The COVID-19 has prompted a lot of rethinking of the conduct of clinical trials. The in-person contact many of these studies require may increase risk to both study staff and research participants. Institutions have taken a variety of approaches, everything from temporarily halting all research, to allowing only those essential to the subjects’ health or wellbeing to continue, to deferring entirely to investigators to decide if and how to continue clinical trials.
The JAMA Network has weighed in with a commentary about continuing research while we deal with the corona virus pandemic. The authors point out that it can be difficult to judge, in a randomized clinical trial, whether study participation provides direct benefit, or is essential to the subjects’ well-being. While a need to monitor for side effects is clear, larger benefit isn’t, as we don’t know about an intervention’s benefits until after the trial is over. In addition, your randomized clinical trial may include a placebo group, who will derive no direct benefit from the intervention (and will, theoretically at least, not have intervention-related side effects to monitor).
We encourage everyone to read the article and give us your thoughts.