How ANA Research is keeping trial subjects safe

David C. Weisman, MD
Director, ANA Clinical Research Center

The FDA recently released guidance on clinical trials in an age of COVID19. The entire guidance boils down to all parties involved in clinical trials “assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.” Usually these mandates don’t oppose each other. The trials are designed to ensure safety of trial participants, which is enshrined in the spirit of good clinical practice. I’m afraid COVID19, however, brings competing goods into opposition. To maintain trial integrity, subjects sometimes have to come into a research center. Part of this is to figure out the response to the drug, and part of it is for safety. Taking a safety lab could puts a subject in danger of coronavirus contact. Consequences follow either way: no safety labs and no trial data or possible coronavirus exposure?

Clinical researchers must now choose one good over another. A hard decision made harder by the nature of what pandemics do. Pandemics don’t just affect a person, which can be tragic enough, they affect and spread from one to another. So there are even more considerations. A trial subject may be happy to come in for labs and for dosing, so is fine with personal risk. But what if he lives in a senior village on lock down? The consequences grow. If infected, he could represent a threat to hundreds more. His high risk tolerance is for himself, can it be applied to others? In this situation, we can’t put people in harm’s way, but we must also continue to conduct clinical trials. Clinical trials will allow us to find out what works to vaccinate against coronavirus or blunt the symptoms of COVID19, not wishful thinking of TV doctors like Dr. Oz.

In response, we stopped screening into trials. Those currently enrolled are being treated in such a way as to reduce risk drastically (spraying down surroundings, going to one place in the clinic, using masks). We will all get through this. At some point we will get through, and continue to devote ourselves to developing novel treatments for Alzheimer’s, Parkinson’s, MS, pain, and stroke.

Stay distant, stay safe, flatten the curve until we have treatments and a vaccine.