Clinical Trials and the COVID-19 Conundrum

Ileana L. Piña, MD, MPH


June 01, 2020

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This transcript has been edited for clarity.

Hello. I'm Ileana Piña, professor of medicine at Wayne State University and Central Michigan University. I'm a heart failure specialist and this is my blog.

We are indisputably in a very difficult time with COVID-19. Maybe you have not thought about this, but we have and we are very concerned about what's going to happen to our clinical trials and our clinical research. Just think about it: You're running along doing fine with a good number of patients that you have enrolled; you are taking care of them and answering important questions. Then, all of a sudden, this happens. What do you do? Do you cancel the study? Do you just stop everything? Stop recruiting but continue the study?

There are many choices but there are some things you might not have thought of—things that trouble us. What if the rate of events changes after COVID-19? Centers right now are saying that they don't have a lot of decompensated patients coming in. There have even been some papers asking, where are the myocardial infarctions? So now the rate of events that you predicted because it gave you power to answer your important question is not there anymore. The rate of events has changed. How are you going to statistically account for a change in the rate of events, whether it's mortality or whether it's hospitalization? How are you going to fit COVID-19 into the rate of events? Are patients not coming in because they are afraid to get infected? These are important questions.

Let me give you some examples. A new trial that has enrolled less than a quarter of patients may be able to just stop and wait and restart recruitment when the country reopens again. However, let's say you needed 2000 patients and now you have 1000. What are you going to do? Are you going to stop the trial? You may not have the power to prove your point. Maybe your point is still a good one. Maybe this study could be positive but you have had to stop. Companies or groups that have already done maybe 75% of their recruitment are in a different situation. Maybe they already have a rate of events so they can stop the trial and do the analysis. You don't want to do the analysis first because you don't want to break the blind. Preserving the blind now becomes an important conversation.

Let's talk about the patients who are enrolled. Whatever the number is, how are you going to do your follow-up visits? Are you going to do it by telehealth, like the way the country is doing office visits? Are you going to do it on the phone? Is it as reliable if you can't see the patient? If your follow-up needs some labs, will the patients be willing to go to a laboratory to get tested? Or will you have to make some arrangements for a home visit by a nurse or a company who will be able to take blood and do the samples? Follow-up may be very different. Studies that have early follow-up, like at a month or 2 months, may be in trouble right now. For those where follow-ups are 3 or 4 months, we may be out of this and they may be able to continue.

Clinical research has been dealt a very heavy blow. We need to come together as a community and think about this, and help each other out in order to not stop all the good work that is being done, and to be able to get the answers that we still desperately need. I hope I leave you with some food for thought. Feel free to discuss with your colleagues. I think they might be very interested too. This is Ileana Piña, signing off. Thank you for joining me today.

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