How to conduct clinical trial during an epidemic: Lessons from the who solidarity trial

The process of conducting this trial during on emerging pandemic is a good case study for future medical researchers. The trial was essentially started with four drugs: remdesivir, hydroxychloroquine, lopinavir and interferon beta-1a. Thus, the end point of the trial was not defined by the clinical efficacy of one particular drug but rather, clinical improvement of the patient (by whatever means) was the sole purpose. This is in sharp contrast to usual clinical trials where the effects of one particular drug is analysed for a long time. A cloud based data management system was used which also factored in local availability of the trial drug(s) before assigning a study subject to a particular arm of therapy. Thus, the need to spend time on procuring a particular drug for the trial was avoided. So, wastage of valuable time in experimenting with futile therapies could be avoided. If anything is not showing significant clinical result within a short time, it must be abandoned and other options looked for. Thus, during a medical emergency, the standard protocol of blinding or using placebo as control was skipped to save time. Since the drugs had different formulations (oral or iv) both the doctor and the patient knew which therapy was being tried. But during an emerging epidemic, when the probable number of persons infected is essentially unknown, this method of calculating sample size is not useful.