According to the NIH, clinical trials are research studies that are “aimed at evaluating the medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.” We partnered with the Clinical Trials Transformation Initiative to co-develop the survey. The Clinical Trials Transformation Initiative or CTTI is focused on developing and driving the adoption of practices that will increase the quality and efficiency of clinical trials. The survey ended up including nearly 850 participants enrolled in clinical trials that spanned 17 different therapeutic areas. Survey responses were collected from 5/8/2020–5/11/2020. Evidation Health’s Director of Partnerships, Bray Patrick Lake presented on the findings here. We wanted to share back some findings with the community! See below for more detail regarding our insights.

Many Clinical Trials Are Completely Stopping Due to COVID-19:

Across all therapeutic areas, 15.7% of participants reported that their trials had been stopped and will not start again; the reported stoppage rates ranged from a low of 6.5% of oncology trials to a high of 22.6% of dermatology trials.

INDIVIDUALS ARE WORRIED ABOUT PARTICIPATING IN TRIALS DUE TO FEAR OF COVID-19 EXPOSURE

35% of the 848 individuals reported feeling worried or very worried about going to a hospital or clinic during the COVID-19 pandemic; 9% overall reported stopping their participation in their clinical trial because they worried about exposure to COVID-19. This concern was particularly salient for immunocompromised individuals; of the 258 individuals who are immunocompromised, 52% reported feeling worried or very worried about going to a hospital or clinic during the COVID-19 pandemic; 12.4% (32) reported stopping their participation in their clinical trial because they worried about exposure to COVID-19.

INDIVIDUALS STILL ENROLLED IN CLINICAL TRIALS ARE CONSIDERING STOPPING DUE TO STRESS AND FEAR OF RISK DUE TO COVID-19

14% (121) of the participants were considering stopping their clinical trials for the following reasons:

• 38% feel too stressed out
• 37% trial not worth the risk to self and others
• 24% too hard or not possible to get to the research site
• 11% too hard to get the medications I’m supposed to take for the study

CLINICAL TRIALS ARE ADAPTING TO REACH INDIVIDUALS IN THEIR HOMES

Of the 335 participants who reported going to in-person visits to the research site or hospital before the pandemic, their trials changed in the following ways after the pandemic started:

• 52% experienced changes to their clinical trial; overall, 19% of those participants said the changes improved their participation experience, 31% worsened, and 50% said there was no impact
• 37% had telemedicine visits added to the trial
• 17% began using an activity tracker or mobile device as part of trial
• 13% began receiving some or all study medications by mail
• 6% reported home visits with the research doctor or nurse

INDIVIDUALS FELT DISSATISFIED WITH THE LACK OF COMMUNICATION ABOUT THEIR CLINICAL TRIALS

8.4% of individuals felt dissatisfied with communications received from investigators or sites about how COVID-19 would impact their clinical trial; of those, 40% reported a desire to receive some communication as they didn’t receive any at all.

COVID-19 has emphasized the need to develop direct connections with individuals. Frequent communication is crucial to understand their trial participation experience and how changes may impact them. These patient-centered practices should be incorporated into future and ongoing trials to ensure a seamless transition from site-based research to research conducted outside of clinic walls.