Problematic issues of clinical trials of drugs in the context of the COVID-19 pandemic

Abstract

In the review the main problematic issues that arose during clinical trials of drugs in the context of the COVID-19 pandemic, when health systems functioned in conditions of force majeure and a lack of resources (human and financial), were examined and summarized. In such a situation, difficulties arose with the
design of studies to assess the effectiveness and safety of drugs for the prevention and treatment of COVID-19, with the recruitment and maintenance of subjects, adherence to research protocols, ethical principles, ensuring the safety of subjects and medical personnel, confidentiality and data integrity. It is
noted that the vast majority of clinical trials, especially at the beginning of a pandemic, were recorded and conducted with questionable methodological quality.
The article also analyzes the main strategies for rapid implementation of medicines for the prevention and treatment of new coronavirus disease into the practice, in particular: testing of known drugs for a new prescription; conducting coordinated clinical trials with the aim of their scaling, accelerating the recruitment of subjects, increasing the reliability of the evidence base; development of a balanced system of information exchange and sharing of data obtained by individual test participants; introduction of temporary alternatives to external monitoring, including the use of electronic means of communication; rapid spread of R&D data on major preprint servers such as medRxiv and bioRxiv; restructuring of control and permitting structures activities by using procedures for rapid approval and introduction of new treatment into medical practice, accelerating examinations and making regulatory decisions without reducing requirements for efficiency and safety.