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.

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 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.)

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.

What is Real-World Data (RWD) and what are the different sources?

Real-world data is the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, for example:

• Electronic health records (EHRs)
• Claims and billing activities
• Product and disease registries
• Patient-generated data including self-reported data entered by the patient or its relatives (e.g Patient-Reported Outcomes – PROs)
• Data gathered from other sources that can inform on health status, such as mobile devices.

What is Real-World Evidence (RWE)?

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.

What is new in July 2021 FDA guidelines?

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.

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.

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. .

For Medical Devices, the FDA is also relying on RWE to support their decisions and to evaluate risk/benefit.

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.

Some examples to Illustrate how FDA rely on RWE to support regulatory decision-making:

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.

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.

How Carenity can help you?

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.).

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.

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:

• Target Product Profiles (TPP) definition
• Study design optimization and protocol evaluation
• Study feasibility assessment
• Endpoint optimization
• Test of patient materials (Informed Consent Form, Information notice, etc.) and patient services

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).

Contact us for more information: pro@carenity.com

Bibliography :

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

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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices

https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-use-transplant-drug-based-real-world-evidence

https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

https://www.ema.europa.eu/en/about-us/how-we-work/big-data

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.

June 18^th, 2021, Paris (FRANCE). Today Carenity, part of the technology-driven data science group EvidentIQ, announced that its PatientLive solution is broadening its offer by entering the oncology therapeutic area. The PatientLive Oncology platform grants access to real-time insights and reliable answers from cancer patients and caregivers with quick surveys.

PatientLive was created by Carenity in 2016 with the purpose of offering pharma companies a unique, compliant, 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. This is why Patient Live allows users to get quick answers from patients to make better decisions.

Carenity’s mission is to help improve medical knowledge and care for chronic patients, including patients with cancer, which is the driving force behind the opening of 18 new PatientLive conditions. These conditions, both in hematology and solid tumors, are: bladder cancer, breast cancer, colorectal cancer, esophageal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, liver cancer, lung cancer, mouth cancer, multiple myeloma, ovarian cancer, pancreatic cancer, prostate cancer, renal cancer, skin cancer, throat cancer, thyroid cancer, and tongue cancer.

Until today, PatientLive offered access to a worldwide online panel of 500,000 patients and caregivers in the following conditions: ankylosing spondylitis, arterial hypertension, asthma, bipolar disorder, COPD, Crohn’s disease, depression, Diabetes (Types 1 and 2), epilepsy, fibromyalgia, lupus, multiple sclerosis, NASH, obesity, osteoarthritis, psoriasis, and rheumatoid arthritis.

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

“PatientLive has always offered quick responses and has been valued for its simplicity and autonomy of use. We want now to make this available for pharma companies focused on oncology and keep this virtuous circle of Data for Good going.”

More about PatientLive

PatientLive is a SaaS platform that allows users to acquire real-time insights through a five-question survey. Five types of questions are available: single choice, multiple choice, 0 to 5 scale, text field, numeric field, and image/video test. Users can access results in real-time, from day 1. Surveys 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.

Learn more about PatientLive in our webinar or contact us for a free trial.