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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 peoples participation in mobile 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 peoples participation in mobile trials.
Currently randomized clinical trials (RCTs) are a key stage in the development of new drugs. Despite the huge scale of the CT market, general awareness of the issue remains low and the society has formed a number of stereotypes and misconceptions about CTs. The presented review of Russian and foreign studies provides the information on the level of general awareness of clinical research in different countries, as well as among patients and practitioners. The conducted literature analysis demonstrates that awareness of clinical trials remains low both in society at large and among patients or in the professional community of practitioners. According to foreign studies, only 20–30% of respondents have heard anything about medical research while a relatively small percentage of respondents have more complete knowledge of RCTs. Among practitioners, only one in five is sufficiently informed about CTs while, according to different data, only about half fully realize what evidence-based medicine is and understand the importance of CTs as a source of reliable knowledge in everyday practice.
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.
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