Too Many COVID Clinical Trials Creating “Traffic Jams”?
[Thursday, July 9, 2020]

Well, not literally, but the various clinical trials being scheduled this summer to evaluate the various vaccine and therapeutic agents for COVID-19 have created a stiff competition for volunteers among the various contenders. Of the more than 130 vaccines for COVID-19 in development, about 17 vaccines are currently in human trials, of which about 6 will get into large Phase 3 clinical trials each involving tens of thousands of participants in the next month or two. That number is further complicated by the fact that another more than 1200 interventional studies are currently ongoing worldwide. Just in the US, these trials will look to recruit more than 200,000 volunteers from practically all clinical centers in the country in 1-4 months. Clinical trial recruitment is exclusive meaning a participant can only enroll in one trial at a time, and the procedure and follow-up periods will make it impractical for any participant to sequentially enroll in more than one trial. There are two reasons to slow down trials: lack of resources and lack of participant pools. There is seemingly no shortage of resources to conduct these trials. The US government alone has committed multi-billion-dollar investment to get the major Phase 3 trials completed. Many other government, non-profit and corporate entities have similarly committed extensive money and resources to expedite the clinical trials. Last week FDA released a new guidance document highlighting the expectations and flexibility available to COVID vaccine trials. But all these resources have created a unique traffic jam of sorts with all the clinical trial teams trying to reach the same pool of participants. It is ironic that on one hand we hear about the increasing numbers of infections and death in the country, on the other we are worried to not be able to recruit sufficient participants fast enough to meet the very ambitious goal of having working vaccine by the end of this year. Our clinical trial machinery is not equipped to capture the actual incidence of any indication, rather only a fraction of the total patient population gets access to any clinical trial. The COVID trials basically present a sped-up model of what actually happens in the clinical trial environment. The early clinical trials find it easier to recruit participants due to the sheer first option advantage. As more and more similar trials come into being, the competition for patients becomes increasingly aggressive, not just because the patients have more options but also based on the outcome of the trials that came before. So, for all those companies that are striving to get a bigger place in the COVID saga, the early birds will get the best pick. Having a lot of competing trials is not necessarily a bad thing. It will encourage the clinical trial machinery to think creatively and expand the patient pool. It will further bolster clinical trial process awareness, the number of new investigators and clinical sites who will do their first trials and probably stay to do more trials later, virtual clinical trials, electronic data capture, real time data analysis, and adaptive clinical trials. The benefits of the increase competition will stick around a lot longer than the pandemic that caused it.