I’m Gilda Teissier, Marketing Director at EvidentIQ and I recently met with Thomas Verjus, Global Business Developer at Carenity, part of the EvidentIQ Group.

Decentralized clinical trials (DCT) are one of the latest clinical research innovations and are defined by Mckinsey as studies “centered around patient needs that improve the patient experience. The focus of such a trial is on making it more convenient, closer to the patients, or both by using a combination of virtual and physical elements to conduct the required trial procedures.”

The COVID-19 pandemic accelerated dramatically the adoption of DCT. In this context, many health regulators (FDA, EMA, MHRA,…) adopted urgent and temporary guidance to allow sponsors to adapt their current protocol and be able to conduct clinical trials remotely. But as time passes, all these regulators have realized that the use of “virtual elements” has grown in parallel with acceptance of “virtual medicine,” accelerating shifts in clinical trial design that many feel are long overdue. The shift has been reinforced by growing digital health technologies and also a rising interest in patient centricity from sponsors.

The following interview will give us an overview on the current DCT landscape and their importance, as well as an insight on the EvidentIQ Way.

Gilda: Why are DCT important?

Thomas: Because they help bring new treatments faster on the market and make it easier to reach demographics which would not have been thought attainable before. In a fully decentralized clinical trial, there is a minimum or even no need to go to a study center, which can accelerate the process and give more options on a pandemic, or not, context. Comparing to traditional clinical research, DCT will allow to speed up patient enrollment, increase patient retention and collect better quality of evidence thanks to remote data collection.

Gilda: How are DCT changing the clinical trial landscape?

Thomas: A few clinical trials were already using some virtual components before 2019. DCT have become a growing market since the COVID-19 pandemic. Recent first guidance published by health authorities are also encouraging a rising DCT adoption. In 2022, it is expected that there will be around 1,300 decentralized trials and/or with a virtual component. This will mean an increase of 28% compared to 2021. So, it is pretty clear that if you want to conduct a successful trial this year, DCT is your answer as it appears to be the new gold standard for the industry.

“In 2022, it is expected that there will be around 1,300 decentralized trials and/or with a virtual component.”

Gilda: Which are the main benefits of DCT?

Thomas: There is a long list of DCT benefits, but in a nutshell, I think we can say that the first and most important is the easy access to patients wherever they live. You can conduct online patient recruitment and hence have faster patient enrollment, especially adapted for some specific diseases. This also helps to have better patient engagement and less drop-out as every step of the trial is easier for them, avoiding burden of onsite visits.

Aside from that we can also mention that DCTs have higher data quality for the sponsor, real-time monitoring, less source data verification, fewer intermediaries, a predefined and compliant format of data, among other things.

Benefits of DCT are “easy access to patients wherever they live. […] better patient engagement […] higher data quality for the sponsor…”

Gilda: Which are the challenges of conducting a DCT?

Thomas: Even though they are the future of clinical trials, there are still some issues that need to be perfected. Some conditions may prevent doing DCT even in hybrid mode, not all the population may have access to the necessary technology or might not be tech oriented. At the same time some of the exams might only be conducted at a hospital. And this is without talking about specific ethical or data privacy regulations.

Before starting a DCT, it’s key to be pragmatic here and ask the good questions to define the most adapted DCT strategy – hybrid of fully decentralized depending on virtual components to be selected.

However, despite this, DCT are worth the while and they are proving to be faster and more effective as time passes while bringing a great option to the table, a more diverse panel.

Gilda: Is it true that the costs of running a DCT are lower?

Thomas: Yes, it is, DTCs are a real game-changer, the time & costs to run a trial are substantially reduced thanks to the model. You only need to remember that every aspect of the trial needs to be thought through, so it can go smoothly and save you money.

“DTCs are a real game-changer, the time & costs to run a trial are substantially reduced thanks to the model.”

Gilda: How is EvidentIQ a key player in DCT?

Thomas: At EvidentIQ we offer a direct access to patients with a global platform of 500k patients on 1,200+ conditions to design a patient centric DCT and speed up patient enrollment. We also combine best-in-class technologies and data sciences services to offer an innovative DCT experience. We have a Hybrid or 100% digital model with fully digital CRO services and innovative data sources to optimize your clinical research.

Gilda: Thanks a lot for your time.

For more information and a deeper understanding on this topic be sure to check out our upcoming webinar on this topic which will take place on March 10th at 5pm CET.

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