Clinical Trials in Russia

The conduct of clinical trials has become increasingly a global enterprise. However, regulation of trials is still largely organized on a regional basis. Thus it matters, from the perspective of the credibility of the results, where a specific trial of interest was conducted. So it was of great interest and the cause of perhaps some apprehension when the first vaccine to be approved for COVID-19 came from Russia, based on clinical trials conducted in Russia, a country without a strong tradition of clinical trials and especially randomized clinical trials.¹ In this issue of Clinical Trials we present three contributions focused on the topic of clinical trials in Russia.

First, Pavel Vasilyev and colleagues present an article that addresses, from a historical perspective, the conduct of clinical trials in Soviet Russia.² The authors use as an example Meldonium, a drug that subsequently came to attention in the West due to its use for performance enhancement in sports, primarily by Russian athletes, notably the tennis star Maria Sharapova. The authors painstakingly searched the Russian State Archive of Scientific and Technical Documentation to piece together methodological details and results from a series of clinical trials of this agent, mostly conducted during the 1980s. These clinical trials addressed the drug’s effect on a variety of medical conditions, leading to its subsequent marketing in Russia and neighboring states. This is a fascinating insight into the manner in which medical research was conducted during the Soviet era. The authors describe the variety of methodological techniques used and point to evidence of the use of “elements of” methodological tools pioneered in the West, such as randomization and the use of placebos, strategies that were considered unethical by the Soviet authorities. Nonetheless, to modern eyes, the entire package of trials produced what feels like a very weak and unconvincing body of evidence concerning the drug, a point emphasized by Janet Wittes in her accompanying Commentary.³ She draws an interesting parallel with the research and teaching of probability theory by Soviet scientists faced with the philosophical inconsistencies between the concept of randomness on which probability theory is based and the dogma of Marxist determinism.

Our final contribution from Russia is the Short Communication authored by Dilyara Nurkhametova and her colleagues in the Russian Cochrane Center.⁴ They bring a very modern perspective to the issue, focusing on the critical topic of clinical trial registration. These authors seek to align the standards of clinical trials conducted in Russia with contemporary global standards but are concerned about the quality of the existing clinical trials registration system, organized by the State Registry of Medicines. They compare features of this system with the corresponding World Health Organization standards, finding a number of areas in which this registry could be improved.

Clinical Trials, and its sponsoring Society for Clinical Trials, has been from its inception devoted to developing and promulgating the very best methodological standards for the design and conduct of clinical research, including the aspirational goal of transparency for reporting results. These are universal aims, and we seek to encourage efforts worldwide to attain them.