COVID-19 Changing Clinical Trials

This year was the first time I’ve attended the AHA’s Scientific Sessions, and although I didn’t get the full experience in a busy conference hall, the virtual experience did have some advantages. I was able to attend every session that interested me, either live or later on demand. In-person discussions were substituted with Zoom rooms, and Twitter threads allowed me to interact with people I may not otherwise have seen. I also liked that I could see all the sessions and posters that are available at a glance. When looking at the schedule, I noticed how much focus Scientific Sessions places on clinical trials and was surprised by the number of variety of ongoing trials.

Before Scientific Sessions, my knowledge of clinical trials was limited to the information in the AHA’s “A Guide to Understanding Clinical Trials”. I learned a lot by watching the various talks, late-breaking science presentations, and “Meet the Trialist” Q&A sessions. I also appreciated that these presentations focused not only on positive results of interventional trials but also on the results of null trials as well as implementation trials focused on care delivery. Several other early career bloggers have written blog posts about the individual trials covered at Scientific Sessions. What interested me the most was the intersection of clinical trials and the COVID-19 pandemic.

Dr. Clyde Yancy stated that “we cannot partition the social experience from the scientific reality, because they are intertwined.” COVID-19 has made this fact especially clear, as science is at the forefront of the public conversation and the social disparities in science and medicine are stark. During the Opening Session, two giants of cardiovascular medicine, Dr. Eugene Braunwald and Dr. Nanette Wenger, along with Dr. Yancy and Dr. Robert Harrington discussed some of these issues in the context of clinical trials and the changes that have been brought about or accelerated by COVID-19.

One important change has been the increase in public-private partnerships and the sharing of data between groups. Dr. Wenger noted that in some fields, there has already been the development of consortiums, large networks of study sites, that are consistently maintained so that large trials can be started efficiently. The prevalence of these is only growing as the benefits of data sharing are becoming more obvious.

They also discussed the increase in clinical trial enrollment during the pandemic. Dr. Braunwald noted that there has been an increase in scientific literacy among the general public, and people know more about clinical trials. They also acknowledged the expansion of telehealth, including video visits, virtual consent, remote monitoring, and the inclusion of patient-entered data, which makes it easier for participants. There has also been a streamlining of protocols, leading to COVID-19 vaccine trials to be conducted with unprecedented speed and allowed the continuation of other current trials.

These changes have led not only to an increased number of study participants but also greater diversity. There tend to be gender and racial disparities among participants of clinical trials, but virtual platforms reduce the cost associated with study participation. However, Dr. Wenger made it clear that minority populations remain underrepresented; trial populations for COVID-19 still do not reflect those most affected by the disease. During the Closing Session, Dr. Norrina Allen discussed some of the population science research presented at Scientific Sessions, showing that racial disparities in health can be attributed to social and environmental drivers. She emphasizes that one way to narrow these gaps and increase diversity in trial enrollment is to increase the diversity of research teams and clinical trial leaders. This has been a thread throughout all of the Scientific Sessions – that diversity and inclusive environments in science and medicine leads to greater equity and better health for all.

 

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