Socio-Psychological Aspects of Introducing Mobile Technologies into Clinical Trials

Background: High political and economic turbulence, changes in the international relations and cross-national economic ties enhance the demand for developing and launching new pharmacological treatments as a part of nationally independent health care program and import substitution policy. The number of clinical trials is growing rapidly, increasing the need for more effective solutions in organizing these trials — optimizing the time, financial resources and efforts of medical personnel. The global trend of creating a new digital ecosystem in health care also raises the issues of higher patient involvement, taking into account the patient's psychological and physical barriers including the issues of personal data security. Aims: Evaluating the motivation and readiness of current clinical trials participants to switch to mobile technologies and identifying the barriers for these shifts. Method: The survey among 75 participants of clinical trials using offline self-completed questionnaire, data processing using statistical tools for data analysis.

Results: Currently, 56% of respondents who are current participants of traditional medical trials would definitely agree to participate in mobile clinical trials. Compared to the consistency rate between traditional clinical trials estimated as 73%, the shift to a new format will result in 17% additional losses. The serious barrier for participation is the concerns about the security of personal information – it is highly relevant for 37% of respondents and moderately relevant for 44%. The important motivating factor for the participation is the open access to personal medical data - 44% of respondents were highly interested in obtaining this data and 31% are somewhat interested. Conclusion. The results of the pilot study confirmed relatively high readiness of current participants to join mobile clinical trials and use mobile devices and solutions in future trials. However the level of readiness is unequal between different socio-demographic groups. Differentiating parameters are age, former experience of clinical trials and the skills in using digital technologies. Training programs for managers and researchers of clinical trials, provision of devices for non-users, timely technical support during the data collection and transparency in data usages can help to address key issues which slow down the people’s participation in mobile trials.