Professor Tobias Welte, one of your particular expertise in research, is participation in clinical trials in general. Of course, the coronavirus situation has brought clinical trials to the forefront of everybody’s mind. What are the main challenges in conducting clinical trials today? Perhaps you could discuss any of the COVID-19 related clinical trials as an example. But it would be important to know your general view.
Coronavirus SARS-CoV-2 is a new virus. And when the pandemic started, more or less, we did not know anything about the virus. You look at the first observational studies and also at the clinical trials. A lot of different substances have been given to patients in parallel. This makes it very difficult to interpret the results of these studies. And it took weeks and months to find the kind of standard treatment, which is anticoagulants—dexamethasone in the more severely ill patients. Antivirals like antibodies are given to severely ill or not so severely ill patients. You need a good control standard, in addition to the investigational track, to get good results. And this is something that had been very, very difficult at the beginning of the COVID-19 pandemic. Many substances did fail in clinical studies, not because they are not effective, but because the study design was not appropriate.
The strength of science is directly related to the control that you are using. And that’s something that has not been done due to different processes. Perhaps it was the urgency of the COVID-19 situation, where clinical physicians felt the necessity to help with what they potentially could help.
Yeah, that’s a problem. If you only have the hydroxychloroquine story in mind. So this was a drug that some physicians, and not only physicians, also the American president was in favor of in the beginning. Hydroxychloroquine was used very widely. But today, we know the efficacy of hydroxychloroquine was low. And the side effects of hydroxychloroquine were big. A lot of very critical side effects, for example, cardiac arrhythmia and other kinds of heart failure. But for a long time, hydroxychloroquine had been used more or less in every patient. It is part of the clinical studies also for other substances. And this is a confounding factor that can bias is the results of the COVID-19 treatment clinical trials.
I think that’s a perfect illustration of the difficulty of using the correct controls in clinical trials. There is significant pressure on physicians on the front line. They have to make a clinical decision in treating the patients. That adds to the pressure to use substances that have not been proven in treatment.
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