Real-world evidence is being used by the health care sector to support the safe development of new medical interventions including devices, services and biopharmaceuticals. Before, it was only considered in the post-approval phase when bringing a new therapy to market, but now, it is being considered earlier in the clinical trial process. What is real-world evidence, how is it used, why is it important, and how can you start harnessing it?

What is Real World Evidence?

Evidence obtained from analyzing real-world data (RWD) is referred to as real-world evidence (RWE). To generate RWE, the RW data must be analyzed. Different statistical analysis can be done through modeling, or by performing a variety of different studies. Technology, like IBM’s Watson, can also be used for data analysis where it aggregates and reports on insights derived from multifaceted real-world data sets.

This real-world data comes from routine delivery of medical care. For example, RWD can come from clinical data such as electronic health records (EHRs) and electronic Case Report Forms (eCRFs). Patient generated data including medical charts, data gathered from mobile devices or wearables, and Patient Reported Outcomes (PRO). PROs are completed by patients and give researchers firsthand patient perspectives and an understanding of events that go on outside of appointments, operations, and hospital stays. Available public health data such as disease registries, prescription habits, and the use of healthcare services, can give data for the general population.  Lastly, cost data in the form of claims or billing activities can provide a monetary indicator for healthcare spending. Patient identity markers are expressly removed to maintain patient privacy. The RWE extracted from these data sources provide insight into elements that are not included in randomized clinical trials (RCT).

How is RWE used?

Real-world evidence enables researchers to assess the efficacy of medical treatments or interventions while considering other circumstances and variables not always accounted for with RCTs. A randomized controlled trial (RCT) enrolls a small subset of the population and examines how different groups react to a novel therapy in a controlled setting. While RCTs are considered ‘the gold standard’ in clinical testing, they are expensive and take a long time to complete. Rather than using RCTs alone, RWE can provide a more comprehensive insight of how a new treatment option will work in the “real world” and for a more diverse population. By supplementing RCTs with RWE, researchers can gain a better understanding of what works for different sub-populations.

RCT suffer from a narrow pool of trial participants and are not truly representative of the general population. Because RCTs have strict inclusion and exclusion criteria for enrollment, certain populations are expressly not represented in the trial, one such example is pregnant women. It is also the case that trials struggle to recruit candidates from certain ethnic populations, as is common for Hispanic communities. With a lack of diverse representation in clinical trials, the results from RCT do not consider all patient characteristics including age, gender, ethnicity, pregnancy, medical history, etc. However, using RWE can fill in some of these gaps.

Why is RWE important?

Real-world evidence can provide insights into how medicines work in certain patient subgroups that may not have been investigated in RCTs. RWE, for example, can allow researchers to investigate how novel medicines function in patients within specific age ranges, or specific socio-demographic groupings. Real-world evidence can also help researchers comprehend what occurs to a patient over the course of his or her life, not only during the RCT period, to assess the treatment’s effectiveness. How people use a product, what symptoms it does improve, side effects — all of that can be different from what is observed in a controlled trial in a clinic. The healthcare industry is constantly working on improving patient outcomes and reducing hospitalization rates. One way to achieve this is to work on more tailored therapies and personalized medicine. Because RWE insights are so valuable, the FDA employs real-world data and RWE to monitor post-market safety and adverse occurrences, and to support regulatory decisions.

RWE also helps improve healthcare decisions and is used in health economics and outcomes research (HEOR). HEOR measures the outcomes of healthcare interventions and the effect they have on patients to provide data and insights for healthcare decision makers. These decision makers include clinicians, governments, payers, health ministries, patients, to name a few. For these stakeholders, real-world data collection, analysis and reporting is essential.

How to collect and use RWE?

With so many varied data sources (clinical data, patient generated data, public health data, cost data) healthcare stakeholders may choose to use clinical trial and data science services. Evident IQ provides researchers with software to collect real-world data and can provide support to analyze RWD to generate and report on RWE.

As part of clinical trial data collection services, EvidentIQ offers eCRF Setup which simplifies electronic data collection forms, design branching questions, develop in-form and cross-form validations and edit checks to maximize data cleaning at the field level. They also provide configuration support for multilingual eCRF forms, and any localization support needed to configure the application workflow to align with the site’s local processes. Their Patient Reported Outcome (PRO) surveys collect a multitude of data points including treatment preference, quality of life, value of health, disease/treatment burden, and unmet needs. This data is then subject to sophisticated methodologies used to generate unique RWE. Data Linkage is one such method. Data Linkage helps match and merge records from different sources to get a richer dataset and more valuable evidence. EvidentIQ uses significant clinical data expertise, data science analysis, and access to Carenity patient platform, to successfully conduct state of the art data linkage studies. Their innovative data linkage capabilities combine unique self-patient reported data with biomarkers collected by a wearable/sensor through continuous monitoring, bringing RWE to the next level.

Real-world evidence is growing in popularity. Before it was only considered in the post-approval period, but now, it is being considered earlier in the clinical trial process. Using RWE at an early stage in treatment development is a critical consideration for healthcare stakeholders and is driving the trend of gathering more RWE and ultimately improving the safety and effectiveness of medical therapies.

Sources: 

https://veradigm.com/real-world-evidence/

https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

https://www.arbormetrix.com/blog/9-ways-real-world-evidence-is-changing-healthcare/

https://vial.com/blog/articles/what-is-real-world-evidence-in-clinical-trials/?utm_source=organic

https://viseven.com/what-is-rwe-in-pharma/

https://servier.com/en/newsroom/folders/importance-real-world-studies/

https://rwe-navigator.eu/use-real-world-evidence/rwe-importance-in-medicine-development/

https://www.clinicalleader.com/doc/why-all-the-talk-about-real-world-evidence-0003

https://www.statnews.com/sponsor/2017/02/16/real-world-evidence-need-2/

https://www.ispor.org/heor-resources/about-heor

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 is it used for?

Evidence generation 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.

Integrated evidence-generation plan (IEP) is a strategy used where the upfront research plan is developed specifically to find evidence to address the concerns of each stakeholder group (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.

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. Patients need to know how the new treatment will meet their needs and solve their problems.

An IEP 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.

Why it is important to have a plan early?

Early evidence-generation planning 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.

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.

What are the main steps where you could need evidence?

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.

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 Health Economics and Outcomes Research (HEOR) strategy, 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.

During the clinical research and development stage is when patient trials and market access strategies start to be executed. Evidence generation collected from Randomized Clinical Trials (RCT) and patient reported outcomes (PRO) can be paired with Real World Evidence 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.

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.

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. Be proactive with your go-to-market strategy, 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 Carenity Patient Platform. Carenity part of the EvidentIQ Group is a key partner to consider to support your data generation plan.

Take a look at our RWE offer.

Sources

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5047978/

https://www.openhealthgroup.com/news/17-01-2022/key-elements-of-a-real-world-evidence-generation-plan
https://marimacinsight.com/evidence-generation-strategy/
https://www.futuremedicine.com/doi/10.2217/cer-2017-0073
https://www.evidera.com/wp-content/uploads/2017/05/Strategic-Evidence-Generation-Planning-Product-Positioning.pdf
https://www.mckinsey.com/industries/life-sciences/our-insights/integrated-evidence-generation-a-paradigm-shift-in-biopharma

Paris (FRANCE), 09.12.2021: Data Linkage by Carenity, part of EvidentIQ demonstrates the group’s unique position to support sponsors better understanding characteristics and needs of the population, with the goal of promoting the development of better tailored health products and services.

Data Linkage is a method that helps match and merge records from different sources to get a richer dataset. This process always uses the highest standards of privacy and safety. The linkage of information enables the construction of chronological sequences of events and when used at the macro level provide valuable information for policy and research into the health and wellbeing of the population.

EvidentIQ uses significant clinical data expertise, data science analysis, and access to Carenity, their patient platform, to successfully conduct state of the art data linkage studies.

Carenity is a social network specially designed for patients with chronic diseases and their caregivers. It has more than 500,000 members in 6 countries (France, Spain, Italy, Germany, United Kingdom and the United States), which gives EvidentIQ a firsthand access to healthcare ad-hoc data if needed.

By working on projects with top 5 pharma, EvidentIQ is showing its proficiency in data generation and is offering its clients a next-level data linkage experience combining data with patients’ insights in a real-world setting using a proactive approach.

Contact us for more information on Data Linkage by EvidentIQ.

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 2016 with the purpose of offering pharma companies a unique and fast way to get access to real-time patient insights. The Carenity 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.
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&D, Clinical development, Clinical operations, Patient engagement, and Medical affairs.

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.

Michael Chekroun, Chief Strategy and Transformation Officer at the EvidentIQ group and Founder of Carenity, tells us about this offering:

“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.”

More about PatientLive®

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 the development of further non-observational studies and Real World Evidence projects.

Contact us for more information on PatientLive® by EvidentIQ.

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 that certain populations have been more affected than others.

Carenity, part of EvidentIQ group, is a leading digital patient platform with 500,000 patients and caregivers worldwide. In the context of COVID-19, Carenity’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 chronic patients, 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. Will chronic patients be the collateral victims of the epidemic?

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.

Gilda: Michael, what made you conduct this survey in the first place? and who did you interview? Was it a special group?

Michael: The pandemic suddenly sent the world into a state of shock in early 2020. The sense of uncertainty was amplified 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.

“We wanted to know what impact this crisis would have on patients with chronic illnesses“

Gilda: 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?

Michael: We surveyed over 3,500 people in Europe and the United States. The results show that there is a strong motivation to get vaccinated. 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.

“The willingness to be vaccinated differs massively between countries”

Gilda: 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?

Michael: 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 many physicians are already concerned about the deteriorating health of their patients.

Gilda: 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?

Michael: 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. I see a bright future for these innovative services, as the COVID-19 crisis has accelerated the adoption of telehealth services by the general public and health care professionals.

Gilda: Physical and mental health 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?

Michael: 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 the number of digital solutions related to mental health is booming. It is one of the most followed subjects by VCs in the US.

Gilda: 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?

Michael: 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 understand the long-term impact of this virus, the effects of which can last several months and which experts now call “long COVID”. 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.

“The challenge now is to understand the long-term impact of this virus”

Gilda: Thank you Michael

Do you want to discover all the results? Join us on June 17 at 17h CET for our webinar on The Impact of COVID-19 on Patients with Chronic Illnesses! Register here

Number of vaccine refusers highest in France, lowest in the UK

Hamburg, 12.05.2021: Data science group EvidentIQ, with its subsidiary company Carenity, has published a survey with 3,353 participants on the situation of chronic patients during the pandemic. The target group included adults from France, the UK, Germany, Italy and the US. Among other findings regarding the number of canceled medical visits and procedures, or the rise of telehealth services, the difference in preparedness for vaccination per country stood out.

The motivation to get vaccinated does not come as a surprise. 48 percent state they are at risk, 46 percent want to protect others and 41 percent simply want to protect themselves from the virus. Only 18 percent indicate it would be easier to travel when vaccinated. The most frequent chronic conditions among the respondents are Type 2 diabetes (24%), asthma (19%), multiple sclerosis (15%) and COPD (14%). Given the severity of these illnesses, it is surprising that a mere 67 percent in France and 47 percent in Germany do not intend to get vaccinated.

Michael Chekroun, Chief Strategy and Transformation Officer of the EvidentIQ group and Founder of Carenity explains these results:

“When it comes to the COVID-19 vaccines, nearly half of our respondents are afraid of side effects. Another 45 percent name the lack of information as reason for their reluctance to be vaccinated. To some extent this is understandable.”

Chekroun refers to the comparably short development and trial phases of the new vaccines. For these highly regulated trial processes imposed by public entities like EMA and FDA – EvidentIQ provides software infrastructure, scientific services and even access to patients to secure and automate testing procedures.

“Many people are not aware that for extraordinary situations like these there have always been Accelerated Approval Programs to shorten time-to-market for a new treatment. This is obviously where chronic patients are understandably nervous, fearing side effects and requiring more information. Our survey shows that only 4 percent of all respondents generally oppose vaccination.”

Also, the survey shows that 46 percent report that medical visits or procedures have been canceled or postponed in the first wave of COVID-19, while 75 percent report the same for wave 2.

This may explain why roughly 67 percent of patients in the US are open to the use of telehealth consultations, in Europe only 47 percent.

Read the the full interview with Michael Chekroun on the outcome of this survey and get a free copy of the complete results.

Contact us for more information.