Клинические исследования ранних фаз глазами здоровых добровольцев

Abstract

Early phase clinical research is an essential step in the development of novel medicinal products. Its main subjects are healthy volunteers. The research quality and outcomes directly depend on how and among whom healthy volunteers are selected and how well the volunteers follow the requirements. Selection of healthy volunteers for participation in early phase clinical research can be influenced by a number of various factors and ethical problems. Better comprehension of volunteer’s expectations, potential fears, limiting factors and motives will promote adherence to respective ethical standards and, as a rule, result in qualitative research practice. In this article, authors have tried to analyze the attitude of healthy volunteers towards various aspects of participation in clinical research using own research experience and available literature data. Surveys of healthy volunteers, individual observations and interviews of researchers with participants represented data to be analyzed. Basic variables of interest included the social and demographic portrait of a healthy volunteer, motivation and barriers to research participation, perception of risks by volunteers and their attitude to adverse events, and financial aspects.