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.

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