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	<title>clinicaltrials Archives - Carenity Pro</title>
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		<title>Carenity, part of the EvidentIQ Group, announces change in leadership</title>
		<link>https://pro.carenity.com/2023/06/01/carenity-part-of-the-evidentiq-group-announces-change-in-leadership/</link>
		
		<dc:creator><![CDATA[Léa Blaszczynski]]></dc:creator>
		<pubDate>Thu, 01 Jun 2023 08:22:21 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Press Releases]]></category>
		<category><![CDATA[carenity]]></category>
		<category><![CDATA[Clinical Data]]></category>
		<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[clinicaltrials]]></category>
		<category><![CDATA[direction]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[life Science]]></category>
		<category><![CDATA[management]]></category>
		<category><![CDATA[rwe]]></category>
		<guid isPermaLink="false">https://www.evidentiq.com/?p=22535</guid>

					<description><![CDATA[<p>Carenity, a prominent patient-centric company and member of the EvidentIQ Group, announces a change in its leadership. Michael Chekroun, founder of Carenity and outgoing President, will be stepping down from his role as of today. Lise Radoszycki, former COO, will be taking the helm as the new President, bringing extensive experience and expertise that will propel the company ...</p>
<p>The post <a href="https://pro.carenity.com/2023/06/01/carenity-part-of-the-evidentiq-group-announces-change-in-leadership/">Carenity, part of the EvidentIQ Group, announces change in leadership</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<div class="fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-1"><p><b>Carenity, a prominent patient-centric company and member of the EvidentIQ Group, announces a change in its leadership.</b></p>
<p><b>Michael Chekroun</b>, founder of <a href="https://www.pressebox.com/redirect/ext?tu=http%3A%2F%2Fwww.carenity.us&amp;rp=eCy4iFpMpcA5YYnyhcsQ3VHY4pLWdqfA8FtcMb1mEuc" target="_blank" rel="noopener">Carenity</a> and outgoing President, will be stepping down from his role as of today.<b> <a href="https://www.pressebox.com/redirect/ext?tu=https%3A%2F%2Fwww.linkedin.com%2Fin%2Flradoszycki%2F&amp;rp=eCy4iFpMpcA5YYnyhcsQ3dYSqtD1356qgZwhGgiZSqI" target="_blank" rel="noopener">Lise Radoszycki</a>, former COO, will be taking the helm as the new President,</b> bringing extensive experience and expertise that will propel the company into its next phase of expansion and development.</p>
<p>Michael Chekroun has played for the past 12 years a central role in building and shaping the company, leading it through successful initiatives, strategic partnerships, and most of all creating a sustainable and innovative model that allows patients to share their experiences while making medical knowledge advance. Michael has chosen to step down, two years after selling his company to <a href="https://www.pressebox.com/redirect/ext?tu=https%3A%2F%2Fwww.evidentiq.com%2F&amp;rp=eCy4iFpMpcA5YYnyhcsQ3TA0X_rvoXKWX_t8Z4W2dfw" target="_blank" rel="noopener">EvidentIQ</a>, to focus on new entrepreneurial projects.</p>
<p>Lise Radoszycki, with a proven track record of success, brings 8 years of experience and a <b>strong vision for Carenity’s future.</b> With a background in data science and biostatistics engineering and having previously occupied crucial leadership roles within the organization, Lise has demonstrated a remarkable ability to effectively implement strategic initiatives and nurture innovation. With her profound industry insights, and exceptional leadership capabilities, Lise is poised to guide Carenity on its continued growth trajectory and ensure that the needs and expectations of patients are better considered by health actors.</p>
<p>Commenting on the leadership transition, Michael said<i> “I am leaving with gratitude and a sense of achievement. I have the conviction that Lise and the team will pursue Carenity’s mission with determination and passion.” </i></p>
<p>Lise expressed her enthusiasm about her new role, stating <i>“I am very honored to be given this opportunity, because this company and its patient-centered values are very important to me. I am committed to driving Carenity&#8217;s growth by prioritizing the patients&#8217; needs in all my decisions, as well as ensuring our clients&#8217; satisfaction by conducting sophisticated RWE studies.”  </i></p>
<p>The board of investors and the entire EvidentIQ team extend their sincere appreciation to Michael for his exceptional leadership, dedication, and numerous contributions. They are confident that Lise will build upon the strong foundation laid by Michael and drive <a href="https://www.pressebox.com/redirect/ext?tu=https%3A%2F%2Fpro.carenity.com%2F&amp;rp=eCy4iFpMpcA5YYnyhcsQ3V4jsrODK3f2V8ROCOBqo6s" target="_blank" rel="noopener">Carenity</a> to even greater success.  </p>
<p><b>About Carenity</b></p>
<p>Carenity, part of the EvidentIQ Group, is a <a href="https://pro.carenity.com/" target="_blank" rel="noopener">leading digital CRO</a> specialized in direct-to-patient studies conducted via its digital social platform supporting +500k patients and caregivers worldwide across 1,200+ illnesses.<br />Since 2011, Carenity’s mission has been to empower patients so they can share their experience with other patients, find information, manage their illness, and generate real-world online research studies.<br />With its innovative platform, Carenity – the Patient Insights Company – delivers timely and compliant direct-to-patient research solutions to the life sciences industry that fuel the development of better medicines and health services.</p>
</p>
<p><a href="https://pro.carenity.com/contact-us/" target="_blank" rel="noopener">Contact us</a> for more information.</p>
</p>
<p>Source: (PresseBox <a href="https://www.pressebox.com/pressrelease/evidentiq-group-gmbh/carenity-part-of-the-evidentiq-group-announces-change-in-leadership/boxid/1160041" target="_blank" rel="noopener">Carenity, part of the EvidentIQ Group, announces change in leadership)</a> (<a href="https://www.pressebox.com/pressrelease/search/keywords/Paris%2C%20France">Paris, France</a>, <time datetime="2023-06-01T08:00:00+02:00">06/01/2023)</time></p>
</p>
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</div></div><style type="text/css">.fusion-body .fusion-builder-column-0{width:100% !important;margin-top : 0px;margin-bottom : 0px;}.fusion-builder-column-0 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 1.92%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 1.92%;}@media only screen and (max-width:1024px) {.fusion-body .fusion-builder-column-0{width:100% !important;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}@media only screen and (max-width:620px) {.fusion-body .fusion-builder-column-0{width:100% !important;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}</style></div></div><style type="text/css">.fusion-body .fusion-flex-container.fusion-builder-row-1{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}</style></div><p>The post <a href="https://pro.carenity.com/2023/06/01/carenity-part-of-the-evidentiq-group-announces-change-in-leadership/">Carenity, part of the EvidentIQ Group, announces change in leadership</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>What is an Integrated Evidence Generation Plan and why you should have one?</title>
		<link>https://pro.carenity.com/2022/11/24/evidence-generation-strategy-planning-an-integrated-approach/</link>
		
		<dc:creator><![CDATA[Lizzi Bollinger]]></dc:creator>
		<pubDate>Thu, 24 Nov 2022 10:51:58 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Clinical Research]]></category>
		<category><![CDATA[clinicaltrials]]></category>
		<category><![CDATA[epro]]></category>
		<category><![CDATA[evidence]]></category>
		<category><![CDATA[evidence generation]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[HEOR]]></category>
		<category><![CDATA[IEP]]></category>
		<category><![CDATA[life Science]]></category>
		<category><![CDATA[lifecycle]]></category>
		<category><![CDATA[outcomes research]]></category>
		<category><![CDATA[patients]]></category>
		<category><![CDATA[PRO]]></category>
		<category><![CDATA[Randomized Clinical Trials]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[real-world evidence]]></category>
		<category><![CDATA[RTMS]]></category>
		<category><![CDATA[rwe]]></category>
		<guid isPermaLink="false">https://www.evidentiq.com/?p=22335</guid>

					<description><![CDATA[<p>An evidence generation strategy is an advanced plan for generating evidence necessary for all the steps of the product life cycle. Traditionally, research follows consecutive steps which is more of a reactive process. Using an evidence generation strategy allows for proactive planning and execution of a holistic strategy. What is evidence generation and what ...</p>
<p>The post <a href="https://pro.carenity.com/2022/11/24/evidence-generation-strategy-planning-an-integrated-approach/">What is an Integrated Evidence Generation Plan and why you should have one?</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-2"><p>An evidence generation strategy is an advanced plan for generating evidence necessary for all the steps of the product life cycle. Traditionally, research follows consecutive steps which is more of a reactive process. Using an evidence generation strategy allows for proactive planning and execution of a holistic strategy.</p>
<h2>What is evidence generation and what is it used for?</h2>
<p><strong>Evidence generation</strong> is multifaceted and includes various study designs and data sources. Typically, each department involved in the process (e.g., clinical development, medical affairs, and health economics and outcomes research (HEOR)) works in a siloed structure and independent from one another to come up with evidence to support their specific research topics.</p>
<p>Integrated evidence-generation plan (IEP) is a strategy used where the upfront research plan is developed specifically to <strong>find evidence to address the concerns of each stakeholder group</strong> (payers, clinicians, patients). Beyond simply proving if a therapy is effective and safe, pharmaceutical companies need to prove that the new treatment is addressing market gaps that the current products do not meet.</p>
<p>Each of these stakeholders have different needs and questions regarding new treatments. Payers, those who pay for the development of the treatment, want to ensure the final product has a value to the healthcare system and will prove to be profitable when launched. Clinicians look for evidence-based research to show how the new treatment is different from existing options. <strong>Patients need to know how the new treatment will meet their needs and solve their problems</strong>.</p>
<p>An <strong>IEP</strong> will pinpoint these motivations from each group and strategically set up testing to address each one. Considered in the planning are all functions, geographies, and the entirety of the life cycle to meet the needs of the various stakeholders. Demonstrating the economic, clinical and patient burden of a disease is a key need early in the development process and sets the stage to inform stakeholders regarding the potential value of a product.</p>
<h2>Why it is important to have a plan early?</h2>
<p>Early <strong>evidence-generation planning</strong> is key to allowing time to connect all the dots between functions and requirements. It is of vital importance when demonstrating value for the new treatment and it must be demonstrated throughout the lifecycle of the product (early development, clinical research, launch, and post approval) to understand the implications of how the product will address needs at each step along the way.</p>
<p>Impactful data points for each function team (medical, clinical, commercial) can be identified and a roadmap created to ensure the evidence-generation plan includes steps to achieve these data results which will add to the products overall value proposition. A cross-functional and early approach ensures the funding and required expertise is available at all stages.</p>
<h2>What are the main steps where you could need evidence?</h2>
<p>The ultimate goal of the treatment is to hit the market and provide a solution for the patient, add value to the healthcare community in the form of a differentiated treatment, while being profitable for the developer. Therefore, during the development of the product, it is beneficial to incorporate these factors into each stage of the product lifecycle.</p>
<p>In the early stages of development, there is a need to understand the current state of care for the target patient population. This includes conducting market research, literature reviews and developing a <strong>Health Economics and Outcomes Research (HEOR) strategy</strong>, identifying possible clinical trial designs, among other tasks that could benefit from evidence-generation. At this point in the product life cycle, the payer stakeholder is interested in the economic burden of disease in order to justify resources required to develop and adopt a new treatment.</p>
<p>During the clinical research and development stage is when patient trials and market access strategies start to be executed. Evidence generation collected from <a href="https://www.evidentiq.com/products/randomisation-and-trial-supply-management/" target="_blank" rel="noopener">Randomized Clinical Trials</a> (RCT) and <strong>patient reported outcomes</strong> (PRO) can be paired with <a href="https://pro.carenity.com/real-world-evidence-generation/" target="_blank" rel="noopener">Real World Evidence</a> for proof of treatment effectiveness and differentiation of current on-the-market products. Clinicians will be most interested in the data that comes from this stage.</p>
<p>To launch a new product, a medical affairs team may use the evidence to inform their market access strategy and develop communications that target patient needs identified early on in the IEP. The launch stage is where the end prescriber and patient will be convinced of the value of the new treatment based on evidence leveraged through the marketing campaign.</p>
<p>The integrated evidence-generation plan utilizes the research results of all functions: market research, health economics and outcomes research, clinical trials, market access, patient-reported outcomes, literature reviews, etc, and combines them with the strategic objectives and ultimate value proposition. <strong>Be proactive with your go-to-market strategy</strong>, and plan in advance to address the needs of each stakeholder group. Along with a software suite for clinical trials, EvidentIQ offers the ability to run prospective and direct-to-patient studies with patient-reported outcomes through its <a href="https://www.carenity.us/" target="_blank" rel="noopener">Carenity Patient Platform</a>. Carenity part of the EvidentIQ Group is a key partner to consider to support your data generation plan.</p>
<p>Take a look at our <a href="https://pro.carenity.com/real-world-evidence-generation/" target="_blank" rel="noopener">RWE offer</a>.</p>
<p>Sources</p>
<p><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5047978/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5047978/</a></p>
<p><a href="https://www.openhealthgroup.com/news/17-01-2022/key-elements-of-a-real-world-evidence-generation-plan">https://www.openhealthgroup.com/news/17-01-2022/key-elements-of-a-real-world-evidence-generation-plan</a><br />
<a href="https://marimacinsight.com/evidence-generation-strategy/">https://marimacinsight.com/evidence-generation-strategy/</a><br />
<a href="https://www.futuremedicine.com/doi/10.2217/cer-2017-0073">https://www.futuremedicine.com/doi/10.2217/cer-2017-0073</a><br />
<a href="https://www.evidera.com/wp-content/uploads/2017/05/Strategic-Evidence-Generation-Planning-Product-Positioning.pdf">https://www.evidera.com/wp-content/uploads/2017/05/Strategic-Evidence-Generation-Planning-Product-Positioning.pdf</a><br />
<a href="https://www.mckinsey.com/industries/life-sciences/our-insights/integrated-evidence-generation-a-paradigm-shift-in-biopharma">https://www.mckinsey.com/industries/life-sciences/our-insights/integrated-evidence-generation-a-paradigm-shift-in-biopharma</a></p>
</div></div><style type="text/css">.fusion-body .fusion-builder-column-1{width:100% !important;margin-top : 0px;margin-bottom : 0px;}.fusion-builder-column-1 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 1.92%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 1.92%;}@media only screen and (max-width:1024px) {.fusion-body .fusion-builder-column-1{width:100% !important;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}@media only screen and (max-width:620px) {.fusion-body .fusion-builder-column-1{width:100% !important;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}</style></div></div><style type="text/css">.fusion-body .fusion-flex-container.fusion-builder-row-2{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}</style></div></p>
<p>The post <a href="https://pro.carenity.com/2022/11/24/evidence-generation-strategy-planning-an-integrated-approach/">What is an Integrated Evidence Generation Plan and why you should have one?</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>Patient recruitment: what are the best practices to make it a success?</title>
		<link>https://pro.carenity.com/2022/09/19/patient-recruitment-what-are-the-best-practices-to-make-it-a-success/</link>
		
		<dc:creator><![CDATA[Lizzi Bollinger]]></dc:creator>
		<pubDate>Mon, 19 Sep 2022 16:18:54 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[clinicaltrials]]></category>
		<category><![CDATA[DCT]]></category>
		<category><![CDATA[patient recruitment]]></category>
		<category><![CDATA[patients]]></category>
		<guid isPermaLink="false">https://www.evidentiq.com/?p=21872</guid>

					<description><![CDATA[<p>Patient recruitment has often focused on traditional media methods like TV, newspaper, and radio, which often lead to a low recruitment conversion rate. Digital patient recruitment can target specific communities that are both more likely to be interested in and eligible to participate in the clinical trial which, in turn, can save money and ...</p>
<p>The post <a href="https://pro.carenity.com/2022/09/19/patient-recruitment-what-are-the-best-practices-to-make-it-a-success/">Patient recruitment: what are the best practices to make it a success?</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-3"><p>Patient recruitment has often focused on traditional media methods like TV, newspaper, and radio, which often lead to a low recruitment conversion rate. <strong>Digital patient recruitment</strong> can target specific communities that are both more likely to be interested in and eligible to participate in the clinical trial which, in turn, can save money and keep the clinical trial on schedule.</p>
<h2>What is patient recruitment?</h2>
<p>Patient recruitment is the process of <strong>identifying, screening, and enlisting eligible patients</strong> that are willing to participate in a clinical trial.</p>
<p>There are different methods of patient recruitment. <strong>Traditional advertising media channels</strong> include TV, radio, or brochures. However, the use of these methods often results in a majority of interested patients being ineligible to participate due to specific exclusion criteria. Investigators can use <strong>existing patient databases</strong> to identify possible candidates but only patients who are searching for clinical trials would be registered in these. That leaves a large untapped market. Patients can also be <strong>recruited directly </strong>by their physician or an advocacy group. This recruitment method generally has a higher conversion rate: the number of potential participants informed about the trial vs. number of patients finally recruited to participate. Patients are more likely to be persuaded by a personal connection than a mass marketing advertisement. Both the physician and advocacy group earn the patient’s trust and act as a liaison informing them of the benefits of the trial and calming any hesitations. <strong>Digital marketing</strong> is also becoming more prevalent. This includes advertising online using <strong>keyword targeting</strong><strong>.</strong> 1 in 3 adults have researched online for medical information. Specific ads are pushed to people who use particular keywords when discussing their conditions on social media or while searching for treatments using search engines. Digital tools can help target wider audiences who already are engaged and interested in a particular illness. These methods typically offer more of a return on investment of advertising funds.</p>
<h2>Challenges of patient recruitment</h2>
<p>Bringing new treatments to market as quickly as possible is the goal of every clinical trial team. <strong>Patient recruitment is a critical part of the trial schedule and budget.</strong> If a trial has trouble with patient recruitment, it can extend the length of the trial timeline and incur additional costs. Also, if the trial fails to get enough participants, and the pre-established sample size is not achieved, it could cause the sponsor to abandon the results. Ultimately, efficient patient recruitment can reduce costs and can ensure the trial completion.</p>
<p>One of the<strong> main challenges</strong> to patient recruitment is that the<strong> number of available patients who meet the trial inclusion criteria</strong> is often fewer than expected. Since conversion rates are usually low, around 10%, the size of the initial patient pool will affect the total number of participants. The next challenge is <strong>identifying and targeting the groups that meet eligibility requirements.</strong> Most people are not familiar with what a clinical trial is or how to participate in one. Therefore, in addition to the challenge of finding eligible patients, it is necessary to also educate and convince them to participate. Finally, <strong>patient retention </strong>is another challenge to completing clinical trials. Patients volunteer to participate in clinical trials and can choose at any time to quit. Prolonged interest in the trial is a vital characteristic that one should look for during the recruitment phase.</p>
<h2>How to conduct proper patient recruitment</h2>
<p>After the proper approvals have been processed for the trial, and the research team assembled, then it is time to start patient recruitment.</p>
<ol>
<li data-leveltext="%1." data-font="Calibri" data-listid="1" data-list-defn-props="{" data-aria-posinset="1" data-aria-level="1">The first step to patient recruitment is to <strong>select the eligibility requirements</strong> for participation and to establish a target audience. Once an ‘ideal’ candidate has been identified, research into that persona type will help the recruiter understand how best to market to them. This research should include:-<b>motivation to participate:</b> What will it take to convince the patient to volunteer their time and energy to participate? Are they motivated by money? In the search for a cure? Will the trial help their condition? What is the value proposition you are offering the candidate? Clearly articulate the relevance of the study and emphasize the possible benefits in your marketing materials.-<b>condition area: </b> What condition do they have? The type of condition may affect a patient’s willingness to participate in trials. According to a study, patients with chronic conditions are less likely to participate in trials for new drugs because it can take a long time to find the correct treatment for these conditions. You should tailor the outreach approaches to match the type of condition.-<b>best marketing media</b>: What marketing channel will they most interact with? What age is the ideal candidate for your study? What media type do they want to interact with? Does this person want a brochure, video, blog, pdf to download? The marketing strategy you develop should match these aspects of your candidate.</li>
<li data-leveltext="%1." data-font="Calibri" data-listid="1" data-list-defn-props="{" data-aria-posinset="1" data-aria-level="1">Create a simple process for participation. The intake paperwork should be user-friendly, easy to understand, and accessible. <strong>Electronic enrollment</strong> is one way to simplify this process and gain more interaction with possible participants. <strong>Digital tools</strong> include online screening questionnaires, scheduling services, and trial information materials. It should be easy for a participant to contact someone involved in the trial and ask questions; this can also be done online.</li>
<li data-leveltext="%1." data-font="Calibri" data-listid="1" data-list-defn-props="{" data-aria-posinset="1" data-aria-level="1">Next, <strong>set goals, milestones, and track the conversion rate</strong>&#8211; how many people see and interact with your marketing vs how many enroll. This will help determine the number of people that need to see your ad before you get enough for your trial- help determine the type of advertising. You may do this through a pilot study and/or through analysis of past trial recruitment statistics.Once you have one persona for each of your ideal candidates, then you may choose to run a <b>pilot study. </b>A pilot study is a scaled down version of the clinical trial requiring fewer participants which tests the trial’s feasibility. If the pilot study fails to recruit enough patients, then it is likely the trial will also fail, and resources would be wasted. The pilot study will also help the researchers identify potential barriers to patient recruitment. Adjustments to the recruitment strategy can be implemented to avoid the same pitfalls during the patient recruitment. This may include changing screening criteria, adding more test sites, or modifying the marketing mix.   If you choose not to do a pilot study, you may analyze data from your past enrollment performance to help you determine a feasible enrollment estimate. This will allow you to adequately manage the finances and staff resources of the study. Pay attention to the number of patients recruited, how long it took to get the first enrollment, and what percentage of the enrollment goal was achieved. Use this past data to identify what form of marketing worked best for the audience.</li>
<li data-leveltext="%1." data-font="Calibri" data-listid="1" data-list-defn-props="{" data-aria-posinset="1" data-aria-level="1"><strong>Create a marketing strategy.</strong> Identify the marketing mix for your message (place-where will you advertise, product-how will you position your trial, price-what is it that you will give the volunteers, promotion- how will you tell your audience about the trial, process-what is the process to be involved, people-who is involved to get your trial participants). Make sure the information is clearly written and easy to understand, pay attention to not use complex medical jargon. Patients need to feel comfortable with the trial and understand the process. The marketing elements should have a clear call to action. Offering them a roadmap of what is expected of them and how the results will be used.</li>
<li data-leveltext="%1." data-font="Calibri" data-listid="1" data-list-defn-props="{" data-aria-posinset="1" data-aria-level="1"><strong>Start recruiting and stay organized.</strong> Execute your carefully planned recruitment. Track all your results and capture, in detail, the contact information from interested patients, even those that may not be eligible because perhaps they will be interested in a future study. Remember to ensure patient privacy and that your data collection/retention is following all privacy laws.</li>
</ol>
<h2>Best practices</h2>
<p><b>Tailor communication strategy. </b>Communication is key to building trust, establishing expectations, explaining processes, and keeping the patients informed. The communication plan starts the first interaction the patient has with the trial. The marketing materials should anticipate and answer the patients’ questions. Do the images and terminology reflect the target population? Take into consideration cultural and language differences of your participants. This will make them feel more at ease and comfortable with the process of the trial.</p>
<p><b>Follow up with patients.</b> Incorporate digital elements like text messages, automated emails or personalized scheduling reminders. These tools can be used to remind patients to take the next steps. Is there constant contact with the trial participant to keep them involved in the trial? Incorporate a range of outreach methods to reach patients and provide them with the necessary information and useful content to keep their interest.</p>
<p><b>Answer every question the patient has regarding the trial. </b>Keep the physician or advocacy group involved and address any doubts, concerns and to convey the benefits of the study. Use social media platforms to keep connected with the audience and inform them of the results via mixed media like infographics and video.</p>
<p><b>Show appreciation for the trial participants. </b>Many are receiving financial compensation but that is not always enough to get a participant to “buy into” the study and continue to give their time. How can this trial benefit them- does it help give them a better understanding of their condition? The trial will also move research forward and can help other patients like them in the future.</p>
<p><b>Keep it interesting. </b>Recruitment and retention are largely affected by the enthusiasm of the lead investigator. If they are showing interest and providing proper follow up because they believe in the success of the study, the participants will too.</p>
<p><b>Include digital tools. </b>Online aspects are used for patient recruitment, retention, and for the trial itself. Digital patient recruitment can target more precisely a larger audience. Follow up messages via email, social media, or text messages are a great way to encourage patients to take the next step and keep them interested. Tracking enrollment numbers and keeping an updated database can help keep investigators organized. The clinical trial itself can be performed ‘decentralized,’ where the patients are all virtual. <b>Digital clinical trials</b> can widen the eligibility pool. If the trial is available remotely, then there are more people that can participate as location is no longer a limitation. In-person aspects of the trial should be coordinated in conjunction with local health sites. Direct-to-patient lab services are also available and can be explored when necessary.</p>
<p>Recruiting enough patients that qualify for clinical trials is always a challenge. Traditional marketing methods often fail to recruit enough trial participants. Now, with the use of digital tools, it is possible to more efficiently and cost effectively target patients willing and able to participate in trials. <strong>EvidentIQ </strong>offers a suite of applications within a single integrated cloud platform for clinical data management, clinical operations, and patient centricity. These digital tools not only help for recruitment but also with patient tracking, communication, retention, and can provide statistics for when planning your next clinical trial.</p>
<p>Take a look at our complete offer<strong> <a style="color: #f01168; text-decoration: underline;" href="https://www.evidentiq.com/products/">here.</a></strong></p>
</div></div><style type="text/css">.fusion-body .fusion-builder-column-2{width:100% !important;margin-top : 0px;margin-bottom : 0px;}.fusion-builder-column-2 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 1.92%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 1.92%;}@media only screen and (max-width:1024px) {.fusion-body .fusion-builder-column-2{width:100% !important;}.fusion-builder-column-2 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}@media only screen and (max-width:620px) {.fusion-body .fusion-builder-column-2{width:100% !important;}.fusion-builder-column-2 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}</style></div></div><style type="text/css">.fusion-body .fusion-flex-container.fusion-builder-row-3{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}</style></div></p>
<p>The post <a href="https://pro.carenity.com/2022/09/19/patient-recruitment-what-are-the-best-practices-to-make-it-a-success/">Patient recruitment: what are the best practices to make it a success?</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>Innovative Real-World-Evidence generation to efficiently combine digital biomarkers and self-reported outcomes</title>
		<link>https://pro.carenity.com/2022/05/18/innovative-real-world-evidence-generation-to-efficiently-combine-digital-biomarkers-and-self-reported-outcomes/</link>
		
		<dc:creator><![CDATA[Léa Blaszczynski]]></dc:creator>
		<pubDate>Wed, 18 May 2022 08:53:17 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Webinars]]></category>
		<category><![CDATA[biomarkers]]></category>
		<category><![CDATA[Clinical Data]]></category>
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		<category><![CDATA[data linkage]]></category>
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		<category><![CDATA[Real World Data]]></category>
		<category><![CDATA[real-world evidence]]></category>
		<category><![CDATA[rwe]]></category>
		<guid isPermaLink="false">https://www.evidentiq.com/?p=21139</guid>

					<description><![CDATA[<p>How to leverage data linkage to get better outcomes? EvidentIQ, a leading clinical data science group, announced its partnership with Feel Therapeutics, a digital therapeutics US-based company. The alliance between these two visionaries of tech has resulted in the building of unique end-to-end solutions to link data and digitize clinical trials through a seamless ...</p>
<p>The post <a href="https://pro.carenity.com/2022/05/18/innovative-real-world-evidence-generation-to-efficiently-combine-digital-biomarkers-and-self-reported-outcomes/">Innovative Real-World-Evidence generation to efficiently combine digital biomarkers and self-reported outcomes</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-4 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-4"><p><em>How to leverage data linkage to get better outcomes?</em></p>
<p>EvidentIQ, a leading clinical data science group, announced its partnership with Feel Therapeutics, a digital therapeutics US-based company. The alliance between these two visionaries of tech has resulted in the building of unique end-to-end solutions to link data and digitize clinical trials through a seamless patient journey supported by direct access to patients, best-in-class technologies and in-house data science expertise.</p>
<ul>
<li>What is Real-World Evidence and the different sources of Real-World Data?</li>
<li>How to collect real-time physiological data 24/7 to monitor emotions, physical activity, and sleep quality: the example of Feel Therapeutics Data Monitoring and Digital Endpoint Discovery Platform</li>
<li>How to efficiently collect self-reported outcomes?</li>
<li>How to combine these two innovative data sources?</li>
</ul>
<p>On May 12th our data linkage webinar took place. We showed you how innovative Real-World-Evidence generation can help to efficiently combine digital biomarkers and self-reported outcomes.</p>
<p>Access the replay! We will walk you through the new data linkage thanks to this partnership, combining best-in-class technologies and expertise of EvidentIQ and Feel Therapeutics.</p>
<p><a role="button" href="https://youtu.be/95l09OY7Emc" target="_blank" rel="noopener"><br />
Access the replay<br />
</a><br />
<a role="button" href="https://news.evidentiq.com/webinar-presentation-data-linkage" target="_blank" rel="noopener"><br />
Download the presentation<br />
</a></p>
<article>Contact us for more information: <a style="color: #14ccad;" href="mailto:info@evidentiq.com" target="_blank" rel="noopener">pro@carenity.com</a></article>
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<p>The post <a href="https://pro.carenity.com/2022/05/18/innovative-real-world-evidence-generation-to-efficiently-combine-digital-biomarkers-and-self-reported-outcomes/">Innovative Real-World-Evidence generation to efficiently combine digital biomarkers and self-reported outcomes</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>Implementing a DCT &#8211; Decentralized Clinical Trial: the road to success</title>
		<link>https://pro.carenity.com/2022/03/16/implementing-a-dct-decentralized-clinical-trial-the-road-to-success/</link>
					<comments>https://pro.carenity.com/2022/03/16/implementing-a-dct-decentralized-clinical-trial-the-road-to-success/#respond</comments>
		
		<dc:creator><![CDATA[Léa Blaszczynski]]></dc:creator>
		<pubDate>Wed, 16 Mar 2022 11:18:40 +0000</pubDate>
				<category><![CDATA[News]]></category>
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		<category><![CDATA[Clinical Data]]></category>
		<category><![CDATA[clinical data management]]></category>
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		<category><![CDATA[DCT]]></category>
		<category><![CDATA[decentralized clinical trial]]></category>
		<category><![CDATA[end-to-end eClinical solution]]></category>
		<category><![CDATA[Patient-Centric]]></category>
		<guid isPermaLink="false">https://evidentiq.com/?p=20079</guid>

					<description><![CDATA[<p>How to leverage both patient centricity and digital innovation in clinical research? Over the past years, clinical research has entered a new area with an increasing adoption of DCT – Decentralized Clinical trial – fully or hybrid, which has been accelerated by the COVID-19 pandemic. Thanks to digital health solutions and the recent evolution of ...</p>
<p>The post <a href="https://pro.carenity.com/2022/03/16/implementing-a-dct-decentralized-clinical-trial-the-road-to-success/">Implementing a DCT &#8211; Decentralized Clinical Trial: the road to success</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-5 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-5"><p><em>How to leverage both patient centricity and digital innovation in clinical research?</em></p>
<p>Over the past years, clinical research has entered a new area with an increasing adoption of DCT – <strong>Decentralized Clinical trial</strong> – fully or hybrid, which has been accelerated by the COVID-19 pandemic. Thanks to digital health solutions and the recent evolution of regulatory framework, DCT means a promising future for clinical trials. However, there are still challenges to define a DCT strategy for a clinical trials.</p>
<p>What are the key success factors to implement a DCT? How to assess what protocol evaluations can be off-site? What are expectations from regulators and IRB/Ethics Committees? How to leverage patient insights to build adapted and patient-centric DCT? How to select the adequate technology components?</p>
<p>On March 10th our Decentralized Clinical Trial webinar took place. We showed you how to leverage both patient centricity and digital innovation in clinical research.</p>
<p>Access the replay! We will walk you through the key steps to implement successfully a DCT and share EvidentIQ’s expertise and state-of-the-art technologies to support your DCT approach.</p>
<p><a role="button" href="https://youtu.be/XpugELx4IiY" target="_blank" rel="noopener"><br />
Access the replay<br />
</a></p>
<article>Contact us for more information: <a style="color: #14ccad;" href="mailto:info@evidentiq.com">info@evidentiq.com</a></article>
</div></div><style type="text/css">.fusion-body .fusion-builder-column-4{width:100% !important;margin-top : 0px;margin-bottom : 0px;}.fusion-builder-column-4 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 1.92%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 1.92%;}@media only screen and (max-width:1024px) {.fusion-body .fusion-builder-column-4{width:100% !important;}.fusion-builder-column-4 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}@media only screen and (max-width:620px) {.fusion-body .fusion-builder-column-4{width:100% !important;}.fusion-builder-column-4 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}</style></div></div><style type="text/css">.fusion-body .fusion-flex-container.fusion-builder-row-5{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}</style></div></p>
<p>The post <a href="https://pro.carenity.com/2022/03/16/implementing-a-dct-decentralized-clinical-trial-the-road-to-success/">Implementing a DCT &#8211; Decentralized Clinical Trial: the road to success</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>Webinar &#8211; Implementing a DCT &#8211; Decentralized Clinical Trial: the road to success &#8211; 10th March 2022</title>
		<link>https://pro.carenity.com/2022/02/18/webinar-implementing-a-dct-decentralized-clinical-trial-the-road-to-success/</link>
					<comments>https://pro.carenity.com/2022/02/18/webinar-implementing-a-dct-decentralized-clinical-trial-the-road-to-success/#respond</comments>
		
		<dc:creator><![CDATA[Léa Blaszczynski]]></dc:creator>
		<pubDate>Fri, 18 Feb 2022 18:27:57 +0000</pubDate>
				<category><![CDATA[Events]]></category>
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		<category><![CDATA[decentralized clinical trial]]></category>
		<guid isPermaLink="false">https://staging.evidentiq.com/?p=18013</guid>

					<description><![CDATA[<p>How to leverage both patient centricity and digital innovation in clinical research? Over the past years, clinical research has entered a new area with an increasing adoption of DCT – Decentralized Clinical trial – fully or hybrid, which has been accelerated by the COVID-19 pandemic. Thanks to digital health solutions and the recent evolution ...</p>
<p>The post <a href="https://pro.carenity.com/2022/02/18/webinar-implementing-a-dct-decentralized-clinical-trial-the-road-to-success/">Webinar &#8211; Implementing a DCT &#8211; Decentralized Clinical Trial: the road to success &#8211; 10th March 2022</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-6 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-6"><p>How to leverage both patient centricity and digital innovation in clinical research?</p>
<p>Over the past years, clinical research has entered a new area with an increasing adoption of DCT – Decentralized Clinical trial – fully or hybrid, which has been accelerated by the COVID-19 pandemic. Thanks to digital health solutions and the recent evolution of regulatory framework, DCT means a promising future for clinical trials. However, there are still challenges to define a DCT strategy for clinical trials.</p>
<p>What are the key success factors to implement a DCT? How to assess what protocol evaluations can be off-site? What are expectations from regulators and IRB/Ethics Committees? How to leverage patient insights to build adapted and patient-centric DCT? How to select the adequate technology components?</p>
<p>Come join us, we will walk you through the key steps to successfully implement a DCT and share EvidentIQ’s expertise and state-of-the-art technologies to support your DCT approach.</p>
<p>Don’t hesitate, register now!</p>
<p><a href="https://www.evidentiq.com/contact/">Contact us</a> for more information.</p>
<p><a role="button" href="https://app.livestorm.co/evidentiq/implementing-a-dct-decentralized-clinical-trial-the-road-to-success" target="_blank" rel="noopener"><br />
Register Now<br />
</a></p>
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<p>The post <a href="https://pro.carenity.com/2022/02/18/webinar-implementing-a-dct-decentralized-clinical-trial-the-road-to-success/">Webinar &#8211; Implementing a DCT &#8211; Decentralized Clinical Trial: the road to success &#8211; 10th March 2022</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>The expanding role of Real-world Evidence in early clinical development</title>
		<link>https://pro.carenity.com/2021/11/17/rwd-in-clinical-development-fda/</link>
					<comments>https://pro.carenity.com/2021/11/17/rwd-in-clinical-development-fda/#respond</comments>
		
		<dc:creator><![CDATA[Thierry Escudier]]></dc:creator>
		<pubDate>Wed, 17 Nov 2021 13:28:23 +0000</pubDate>
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		<category><![CDATA[FDA]]></category>
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		<category><![CDATA[Real World Data]]></category>
		<category><![CDATA[real-world evidence]]></category>
		<guid isPermaLink="false">https://staging.evidentiq.com/?p=14890</guid>

					<description><![CDATA[<p>Why collecting Real World Data is important to optimize clinical trials and get new medical product approved? In clinical development, the traditional approach to demonstrate efficacy and safety of a new drug has always been in performing the traditional Randomized Clinical Trials (RCT) programs since this is considered by Regulatory Agencies as the best ...</p>
<p>The post <a href="https://pro.carenity.com/2021/11/17/rwd-in-clinical-development-fda/">The expanding role of Real-world Evidence in early clinical development</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-7 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-7"><h2>Why collecting Real World Data is important to optimize clinical trials and get new medical product approved?</h2>
<p>In clinical development, the traditional approach to demonstrate efficacy and safety of a new drug has always been in performing the traditional Randomized Clinical Trials (RCT) programs since this is considered by Regulatory Agencies as the best compromise to get sufficient, well-structured data from a subgroup of the future patient population in a reasonable time frame. However, these programs are highly cost-consuming and require the involvement of human resources (physicians, clinical research associates, etc.)</p>
<p>When a drug is assessed, Regulators and Health Technology Assessment (HTA) bodies require getting a far more extended set of data from a larger population and closer to normal life conditions. Having access to real life data enable to have a better understanding of disease and treatment burden, patient experiences, preferences to be able to establish how much the drug will cover unmet needs.</p>
<h2>What is Real-World Data (RWD) and what are the different sources?</h2>
<p>Real-world <em><strong>data</strong></em> is the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, for example:</p>
<ul>
<li>Electronic health records (EHRs)</li>
<li>Claims and billing activities</li>
<li>Product and disease registries</li>
<li>Patient-generated data including self-reported data entered by the patient or its relatives (e.g Patient-Reported Outcomes – PROs)</li>
<li>Data gathered from other sources that can inform on health status, such as mobile devices.</li>
</ul>
<h2>What is Real-World Evidence (RWE)?</h2>
<p>Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective). RWE is increasingly used in drug development and evaluation as shown by the recent guidelines published by the FDA.</p>
<h2>What is new in July 2021 FDA guidelines?</h2>
<p>Since 2016, after the publication of the 21st century Cure Acts, the FDA is taking into account RWD for the evaluation of new drugs/medical devices, mostly to monitor post-marketing safety or support extension of indications.</p>
<p>In July 2021, the FDA published guidelines to illustrate the interest of implementing RWD during clinical development phase and not only at the end of that lengthy phase. There are many approaches from including RWD in the RCT up to implement specific trials in parallel to the pivotal program. RWE is not a substitute for RCTs but should be seen as complementary, each type of study design providing information the other cannot.</p>
<p>Due to long processes during new drug/medical device development, pharmaceutical companies should evaluate the best approach to collect data as early as possible. Indeed bringing patient perspective into clinical projects can accelerate clinical trials, save costs and ensure the success of new products. .</p>
<p>For Medical Devices, the FDA is also relying on RWE to support their decisions and to evaluate risk/benefit.</p>
<p>EMA (European Medicines Agencies) is also working with European National Agencies on a strategic plan for 2023 road map in favor of the use of RWE in clinical development considering the benefit of having access upfront to real world data.</p>
<h2>Some examples to Illustrate how FDA rely on RWE to support regulatory decision-making:</h2>
<p>In July 2021, U.S. Food and Drug Administration approved a new indication for Prograf (tacrolimus) based on an observational, non-interventional study providing real-world evidence (RWE) of effectiveness. FDA approved Prograf for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation.</p>
<p>In a more recent time, FDA has decided for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in specific subset of population: the decision was partly based on real-world data on the vaccine’s effectiveness over a sustained period of time provided by both U.S. and international sources, including the CDC (Centers for Disease Control and Prevention), the UK and Israel.</p>
<h2>How Carenity can help you?</h2>
<p>Carenity, part of the EvidentIQ group, offers Real-World Evidence solutions to collect and analyze self-reported patient information (ePROs, patient preference information using Discrete-Choice Experiment designs, e-diaries, etc.).</p>
<p>Carenity relies on its global digital platform that engages more than 500,000 patients and caregivers in Europe and North America to conduct prospective non-interventional studies (cross-sectional and longitudinal designs). Theses observational studies can generate meaningful information about quality of life, disease and treatment burden, product effectiveness, patient preferences, etc.</p>
<p><strong>Carenity supports its Life Sciences Industry clients at each step of the clinical development to ensure the success of patient recruitment and retention thanks to patient-centric decision-making:</strong></p>
<ul>
<li>Target Product Profiles (TPP) definition</li>
<li>Study design optimization and protocol evaluation</li>
<li>Study feasibility assessment</li>
<li>Endpoint optimization</li>
<li>Test of patient materials (Informed Consent Form, Information notice, etc.) and patient services</li>
</ul>
<p>Carenity also offers PatientLive®, a self-service platform to collect real-time patient insights. This unique solution allows to get fast answers from patients and caregivers and make better decisions via a quick poll (1-5 questions).</p>
<p>Contact us for more information: <a href="mailto:pro@carenity.com">pro@carenity.com</a></p>
<p>Bibliography :</p>
<p>https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence</p>
<p>https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biologics-guidance</p>
<p>https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices</p>
<p>https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-use-transplant-drug-based-real-world-evidence</p>
<p>https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations</p>
<p>https://www.ema.europa.eu/en/about-us/how-we-work/big-data</p>
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<p>The post <a href="https://pro.carenity.com/2021/11/17/rwd-in-clinical-development-fda/">The expanding role of Real-world Evidence in early clinical development</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>PatientLive® opens its doors to the clinical market</title>
		<link>https://pro.carenity.com/2021/10/25/patientlive-opens-door-clinicalmarket/</link>
					<comments>https://pro.carenity.com/2021/10/25/patientlive-opens-door-clinicalmarket/#respond</comments>
		
		<dc:creator><![CDATA[Sabine Birkner]]></dc:creator>
		<pubDate>Mon, 25 Oct 2021 12:47:54 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Press Releases]]></category>
		<category><![CDATA[clinicaltrial]]></category>
		<category><![CDATA[clinicaltrials]]></category>
		<category><![CDATA[life Science]]></category>
		<category><![CDATA[patient Poll]]></category>
		<category><![CDATA[patients]]></category>
		<category><![CDATA[realworldevidence]]></category>
		<category><![CDATA[sciencesponsors]]></category>
		<category><![CDATA[survey]]></category>
		<guid isPermaLink="false">https://staging.evidentiq.com/?p=15936</guid>

					<description><![CDATA[<p>PatientLive® is a unique solution that allows to quickly survey an online community of 500,000 patients and caregiversstudies Paris (FRANCE), 25.10.2021. Today EvidentIQ announced that its PatientLive® software is opening its doors to the clinical market. The PatientLive® platform grants access to real-time insights and reliable answers from patients and caregivers through quick polls. PatientLive® was created by Carenity, part of the EvidentIQ group, in ...</p>
<p>The post <a href="https://pro.carenity.com/2021/10/25/patientlive-opens-door-clinicalmarket/">PatientLive® opens its doors to the clinical market</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-8 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-8"><p><strong>PatientLive® is a unique solution that allows to quickly survey an online community of 500,000 patients and caregiversstudies</strong></p>
<p><a style="color: #14ccad;" href="https://www.pressebox.de/pressemitteilung/suche/schlagwoerter/Paris%20%28FRANCE%29">Paris (FRANCE)</a>, 25.10.2021. <strong>Today EvidentIQ announced that its PatientLive® software is opening its doors to the clinical market. The PatientLive® platform grants access to real-time insights and reliable answers from patients and caregivers through quick polls.</strong></p>
<p><a style="color: #14ccad;" href="https://www.patient-live.com/" target="_blank" rel="noreferrer noopener">PatientLive®</a> was created by <a style="color: #14ccad;" href="https://pro.carenity.com/" target="_blank" rel="noreferrer noopener">Carenity</a>, part of <a style="color: #14ccad;" href="https://www.evidentiq.com/" target="_blank" rel="noreferrer noopener">the EvidentIQ group</a>, in 2016 with the purpose of offering pharma companies a unique and fast way to get access to real-time patient insights. The <a style="color: #14ccad;" href="https://www.patient-live.com/" target="_blank" rel="noreferrer noopener">Carenity</a> team believes that guesswork is no longer enough but knows that time is also valuable. Therefore PatientLive® allows to collect real-time patient insights at a fast pace, in order to help make better strategic decisions regarding clinical patient-centric projects.<br />
Carenity’s mission is to bring patient perspective into clinical projects to accelerate clinical trials, save costs and ensure the success of new products. With this revolutionary software, the life science industry can leverage real-time patient insights at each phase of the clinical development like early R&amp;D, Clinical development, Clinical operations, Patient engagement, and Medical affairs.</p>
<p>PatientLive® can help understand patient experience (burden, Quality of life) to define Target Product Profiles, evaluate patient’s acceptance of protocol evaluation parameters and flow chart, incorporate study endpoints that are valuable from a patient perspective, optimize the design of clinical trials to facilitate patient recruitment and retention, identify preliminary feasibility for clinical projects, ensure study materials are patient-centric and easy to understand (ICF testing), and test concepts of services and tools to increase patient retention on clinical trials.</p>
<p>Michael Chekroun, Chief Strategy and Transformation Officer at the EvidentIQ group and Founder of Carenity, tells us about this offering:</p>
<p>“PatientLive® has always offered quick responses and has been characterized for its simplicity and autonomy of use. We want now to make this available for the clinical markets and keep this virtuous circle of Data for Good going.”</p>
<p><a href="https://www.patient-live.com/" target="_blank" rel="noopener"><strong>More about PatientLive®</strong></a></p>
<p>PatientLive® is a unique solution that allows to quickly survey an online community of 500,000 patients and caregivers in the US and Europe with up to 36 conditions available, letting users acquire real-time insights via a five-question poll. Five types of questions including images and videos are available: single choice, multiple choice, 0 to 5 scale, text field, and numeric field. Polls on PatientLive® initiate patients data generation on topics including: disease/treatment burden, unmet needs, quality of life, services and communication message testing, and information and service needs. These early insights are invaluable for PatientLive® users as they enable better patient-centric solutions and materials and may guide <strong>the development of further non-observational studies and Real World Evidence projects.</strong></p>
<p><a style="color: #14ccad;" href="https://pro.carenity.com/contact-us/" target="_blank" rel="noopener">Contact us</a> for more information on PatientLive® by EvidentIQ<a href="mailto:info@evidentiq.com">.</a></p>
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<p>The post <a href="https://pro.carenity.com/2021/10/25/patientlive-opens-door-clinicalmarket/">PatientLive® opens its doors to the clinical market</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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		<title>Interview &#8211; What is the impact of COVID-19 on chronic patients?</title>
		<link>https://pro.carenity.com/2021/05/12/interview-what-is-the-impact-of-covid-19-on-chronic-patients/</link>
		
		<dc:creator><![CDATA[Gilda Teissier]]></dc:creator>
		<pubDate>Wed, 12 May 2021 14:51:00 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Clinical Research]]></category>
		<category><![CDATA[Clinical Trial Data]]></category>
		<category><![CDATA[Clinical trial systems]]></category>
		<category><![CDATA[clinicaltrials]]></category>
		<category><![CDATA[covid-19]]></category>
		<category><![CDATA[life Science]]></category>
		<category><![CDATA[patient centricity]]></category>
		<guid isPermaLink="false">https://www.evidentiq.com/?p=21323</guid>

					<description><![CDATA[<p>I'm Gilda Teissier, Executive Marketing Director at EvidentIQ and I recently met with Michael Chekroun, Founder and CEO at Carenity and Chief Strategy and Transformation Officer at EvidentIQ Group for this interview. COVID-19 has been among us for more than a year now and it has impacted the life of every person in the world. It goes without saying ...</p>
<p>The post <a href="https://pro.carenity.com/2021/05/12/interview-what-is-the-impact-of-covid-19-on-chronic-patients/">Interview &#8211; What is the impact of COVID-19 on chronic patients?</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><div class="fusion-fullwidth fullwidth-box fusion-builder-row-9 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling" style="background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#eae9e9;border-style:solid;" ><div class="fusion-builder-row fusion-row fusion-flex-align-items-flex-start" style="max-width:1216.8px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_1 1_1 fusion-flex-column"><div class="fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column" style="background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;"><div class="fusion-text fusion-text-9"><p>I&#8217;m Gilda Teissier, Executive Marketing Director at EvidentIQ and I recently met with <a href="https://www.linkedin.com/in/michael-chekroun-00252a/" target="_blank" rel="noopener">Michael Chekroun</a>, Founder and CEO at <a href="https://www.linkedin.com/company/carenity" target="_blank" rel="noopener">Carenity</a> and Chief Strategy and Transformation Officer at <a href="https://www.linkedin.com/company/evidentiq" target="_blank" rel="noopener">EvidentIQ Group</a> for this interview.</p>
<p><strong>COVID-19 has been among us for more than a year now and it has impacted the life of every person in the world. It goes without saying that certain populations have been more affected than others.</strong></p>
<p><a href="https://www.carenity.us/" target="_blank" rel="nofollow noopener">Carenity</a>, part of <a href="https://www.evidentiq.com/" target="_blank" rel="nofollow noopener">EvidentIQ group</a>, is a leading digital patient platform with <strong>500,000 patients </strong>and caregivers worldwide. In the context of COVID-19, Carenity&#8217;s mission has been more than ever to support its patient community and to help healthcare actors quickly access the best possible data to provide the highest quality of care to patients. In this sense, Carenity has set up an online survey to measure the impact of COVID-19 on access to care and quality of life in real-time for <strong>chronic patients</strong>, a population that is particularly vulnerable in a context of pandemic and lockdown. While attention is primarily focused on those affected by COVID-19, the risk of poor, insufficient access to care for chronic patients is real, with potential dramatic consequences. <strong>Will chronic patients be the collateral victims of the epidemic?</strong></p>
<p>This survey was conducted at three different periods in the following 6 countries: France, the UK, Germany, Italy, Spain, and the US. The first survey was conducted during the first lockdown in Q2 2020, the second after the summer 2020, and the last from December 2020 until April 2021. The results from all three surveys have been shared with both the patient and healthcare communities. Today we have the opportunity to get some deeper insights on the key results thanks to Michael Chekroun, Founder and CEO of Carenity and Chief Strategy and Transformation Officer at EvidentIQ Group.</p>
<p><strong>Gilda:</strong> Michael, what made you conduct this survey in the first place? and who did you interview? Was it a special group?</p>
<p><strong>Michael: </strong>The pandemic suddenly sent the world into a state of shock in early 2020. The sense of <strong>uncertainty was amplified</strong> by the lockdown measures that followed in many countries. At Carenity, we wanted to know what impact this crisis would have on patients with chronic illnesses, both in terms of access to care and impact on their quality of life, to find quick solutions to protect an already fragile population.</p>
<h2><i>&#8220;</i>We wanted to know what impact this crisis would have on patients with chronic illnesses<i>&#8220;</i></h2>
<p><strong>Gilda:</strong> One of the central questions was about patients’ intention to be vaccinated. What did you find out about people’s willingness to get vaccinated and what do you think are the reasons?</p>
<p><strong>Michael: </strong>We surveyed over 3,500 people in Europe and the United States. The results show that there is a<strong> strong motivation to get vaccinated.</strong> 48% of respondents said it is because they were at risk, 46% wanted to protect others and 41% just wanted to protect themselves from the virus. That said, the survey indicates that the willingness to be vaccinated differs massively between countries.</p>
<h2><i>&#8220;The willingness to be vaccinated differs massively between countries&#8221; </i></h2>
<p><strong>Gilda:</strong> When it comes to medical consultations and healthcare professionals, have you seen an improvement in the situation with regard to medical visits or procedures being canceled or postponed since the first lockdown? What do you think is the reason for this?</p>
<p><strong>Michael: </strong>Nearly half of those surveyed reported that their medical visits or procedures were canceled or postponed during the 1st wave of the virus, during the spring of 2020, while 75% reported experiencing the same difficulties in late 2020 and early 2021. It is difficult to estimate the long-term impact, but<strong> many physicians are already concerned about the deteriorating health of their patients.</strong></p>
<p><img fetchpriority="high" decoding="async" src="https://www.evidentiq.com/wp-content/uploads/2021/05/1620734106416-1024x485.png" alt="" width="800" height="379" /></p>
<p><strong>Gilda:</strong> There are many digital solutions now offering teleconsultation services. Based on the barometer’s findings, do you think there is a real market out there for video consultation platforms?</p>
<p><strong>Michael: </strong>Yes, absolutely. Roughly 67% of patients in the US would be willing to use telehealth consultations and in Europe 47% of respondents are open to telehealth. <strong>I see a bright future for these innovative services</strong>, as the COVID-19 crisis has accelerated the adoption of telehealth services by the general public and health care professionals.</p>
<p><strong>Gilda:</strong> <strong>Physical and mental health</strong> have been an important element and a casualty of this pandemic. Have these two aspects also worsened for people living with chronic illnesses and to what extent?</p>
<p><strong>Michael: </strong>The pandemic is expected to have a long-term effect on the mental health of people populations around the world, especially the youngest and most fragile. Again, it is difficult to estimate the long-term impact, but we can already see that <strong>the number of digital solutions related to mental health is booming.</strong> It is one of the most followed subjects by VCs in the US.</p>
<p><strong>Gilda:</strong> Information is essential when faced with uncharted territory such a pandemic, and most of all when living with a chronic condition. Has people with chronic conditions been given enough information? What do patients think?</p>
<p><strong>Michael: </strong>Information is not the problem. We have been literally inundated with information about the virus, its impact, its variants and its treatments. So much so that everyone feels able to judge the effectiveness or the safety of a particular vaccine. Moreover, a majority of the patients surveyed consider themselves well informed about the virus or the vaccines. The challenge now is to <strong>understand the long-term impact of this virus</strong>, the effects of which can last several months and which experts now call &#8220;long COVID&#8221;. Even if we can see the light at the end of the tunnel thanks to vaccination, we must remain cautious in a field where knowledge evolves daily.</p>
<h2><i>&#8220;The challenge now is to understand the long-term impact of this virus&#8221;</i></h2>
<p><strong>Gilda:</strong> Thank you Michael</p>
<p><strong>Do you want to discover all the results?</strong> Join us on <strong><u>June 17 at 17h CET</u></strong> for our <strong>webinar</strong> on The Impact of COVID-19 on Patients with Chronic Illnesses! <a href="https://app.livestorm.co/carenity-com/webinar-3-the-impact-of-covid-19-on-chronic-patients-5pm-cet" target="_blank" rel="nofollow noopener">Register here</a></p>
<p><img decoding="async" src="https://www.evidentiq.com/wp-content/uploads/2021/05/1620734975312-1024x568.png" alt="" width="800" height="444" /></p>
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<p>The post <a href="https://pro.carenity.com/2021/05/12/interview-what-is-the-impact-of-covid-19-on-chronic-patients/">Interview &#8211; What is the impact of COVID-19 on chronic patients?</a> appeared first on <a href="https://pro.carenity.com">Carenity Pro</a>.</p>
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