Volunteers in bioequivalence clinical trials: premises for participation. Part 1

Abstract

Clinical trials, as an integral stage of the creation of any drug, require volunteers who are ready to go through the testing stage. Clearly, participation in a trial of any drug carries certain health risks, which makes it difficult to recruit volunteers. Development companies use various methods to stimulate potential participants, including regular monitoring of health status, creation of comfortable living conditions, free treatment, financial compensation for risks, etc. Particularly relevant for manufacturing companies is the recruitment of volunteers in case of conducting a bioequivalence phase study, when an already known drug, planned for release under a different brand (name), is being tested. The article presents the results of interviews with volunteers in order to study their motivation to participate in clinical trials of the bioequivalence phase, their experience of such participation, as well as opinions regarding the organization of clinical trials in the Russian Federation. The results of the study demonstrate a high level of interest among the volunteers to regularly participate in bioequivalence studies due to their relative safety for health, as well as financial interest and comfortable organization of the trial process. The socio-demographic profile of the “bioequivalence phase volunteer” is described, and the tendency towards the formation of a community of volunteers with experience of repeated participation in clinical trials for financial reward is identified.