As of July 9th, more than 1000 organizations have reported disruption in their clinical trials due to COVID-19. Forty-two percent of sites in the U.S. have said their trials have been stalled.
This has forced researchers to reconsider protocol design in favor of virtual clinical research to prioritize participant safety and maintain study integrity while adhering to social distancing guidelines.
The virtual transformation that once seemed radical is now on the fast track. Of course, it’s a mammoth transition for sponsors, but for patients, most indicators suggest it’s an easy and worthwhile shift. Patients are open to participating in research during the pandemic but prefer the use of digital means for permitting remote participation. It appears many are realizing the numerous benefits of the virtual frontier.
Here are the three biggest reasons why:
1) Safety: Site visits are stressful, especially during a pandemic
A study conducted before the pandemic showed nearly 40 percent of clinical research dropouts deemed site-visits as “very/somewhat” stressful. As COVID-19 continues to ravage the United States, patients aren’t merely stressed about visiting a clinic, they’re fearful it could lead to an infection, hence why they are avoiding doctors’ offices and hospitals altogether. The number of primary care doctors’ office visits has plummeted by 60 percent since the pandemic began. Furthermore, ACRP has reported an alarming increase in site suspensions of 10 percent over the last two months.
Virtual trials remove this fear, allowing patients to partake in a study from the safety of their home while maintaining virtual communications with the study team.
2) Accessibility: No geographic restraints
Experimental treatment options may thus be inaccessible to those who need them the most; 85 percent of patients are willing to participate in clinical research, but nearly 70 percent live more than two hours away from a study center.
Because there is no traditional site involved in a virtual trial, sponsors can write protocols that allow patients to live anywhere. For instance, ObvioHealth recently ran an entirely virtual dermatology study that recruited participants across 48 states in the U.S.
3) Flexibility: Less Disruption to daily life
For some populations, like working or single parents, spare time is hard to come by. While these people may live close to a trial site, their life circumstances – childcare or scheduling concerns – are major barriers to participation.
A 2018 Tufts University report shows that protocol complexity has significantly increased over the past decade – with the total number of endpoints collected rising by 86 percent. This stat signifies the growing burden placed on patients.
When able to participate virtually, patients can complete tasks while “on-the-go” or at-home, with little-to-no disruption to their daily routines.
What does it all mean?
Site visits pose many problems for clinical trial sponsors, especially during the ongoing pandemic. However, research can continue with minimized risk for all involved when done virtually.
Patients are adapting quickly, and as virtual becomes the norm, convincing participants to join traditional trials will be difficult. In the words of one of ObvioHealth’s past study participants: “I had to physically go everywhere, and there was a lot of email back and forth. I definitely prefer anything that has an app.”
To learn more about the urgent need for a virtual transformation in clinical research, click here.
Written by Parth Shah, M.D., Medical Director
Parth is a physician scientist with diverse clinical and research experience. He is an expert in cardio-metabolic and endocrine diseases and is passionate about improving patient care via advancements in research. Dr. Shah serves as an investigator in sponsored and investigator initiated studies. He has great experience in all phases of clinical trials from planning and development to its execution. Dr. Shah is skilled at providing medical input to cross functional teams such as clinical operations, IT, business development, biostatistics, pharmacovigilance, etc.
Dr. Shah has published many manuscripts in credible, peer-reviewed medical journals and presented research at prestigious medical conferences.
He earned a Bachelor of Science from Youngstown State University, Doctor of Medicine from Washington University of Health and Science, and served as a clinical fellow/researcher at Mercy Health/Jewish Hospital.