Olga Zvonareva1, Natalia Kutishenko2, Evgeny Kulikov3, Sergey Martsevich2. 1. Department of Health, Ethics and Society, Maastricht University, Maastricht, The Netherlands Research Centre for Policy Analysis and Studies of Technologies (PAST-Centre), National Research Tomsk State University, Tomsk, The Russian Federation o.zvonareva@maastrichtuniversity.nl. 2. Department of Preventive Pharmacotherapy, National Research Center for Preventive Medicine, Moscow, The Russian Federation. 3. Siberian State Medical University, Tomsk, The Russian Federation.
Abstract
BACKGROUND: The Russian Federation is one of the emerging clinical trial regions where the numbers of international clinical trials have been significantly rising over the course of recent years. PURPOSE: Our aims were to describe and explain risk-benefit calculus by clinical trial participants in Russia and to analyse the significance of the results for the ethical regulation of globalizing clinical trials. METHODS: In-depth semi-structured interviews were conducted with 21 individuals participating in trials for cardiovascular disease. Analysis was based on the inductive constant comparative method. RESULTS: Interviewed participants perceived multiple benefits in trial enrolment including regular check-ups, provision and explanation of individual test results, the opportunity to ask investigators for advice and the provision of treatment recommendations for those with limited access to a physician outside of the trial. Participants tried to manage risks of trial enrolment by paying attention to how they felt and reporting changes to investigators. Regular monitoring, the opportunity to drop out of the trial and health insurance provision in case of adverse events were viewed as further minimizing individual risks. Importantly, interviewed trial participants did not assess the risks and benefits of a single trial independently of wider social situation or particularities of their own health condition. Value of trial enrolment benefits for participants was enhanced by the healthcare system that was viewed as being unresponsive to the needs of people with cardiovascular disease. Therefore, in their risk-benefit assessment, participants weighed enrolment risks against the risks of dealing with their fragile health without continuous contact with a medical professional. LIMITATIONS: A relatively small number of interviews was conducted, only participants of cardiovascular disease trials were interviewed and the extent to which the described perspectives are generalizable is not established. CONCLUSION: The risk-benefit assessment as performed by most interviewed trial participants involved multiple components, including the ones unrelated to the trial itself, and was largely context-dependent. Perspectives of research participants can enrich frameworks for the evaluation of trial risks and benefits.
BACKGROUND: The Russian Federation is one of the emerging clinical trial regions where the numbers of international clinical trials have been significantly rising over the course of recent years. PURPOSE: Our aims were to describe and explain risk-benefit calculus by clinical trial participants in Russia and to analyse the significance of the results for the ethical regulation of globalizing clinical trials. METHODS: In-depth semi-structured interviews were conducted with 21 individuals participating in trials for cardiovascular disease. Analysis was based on the inductive constant comparative method. RESULTS: Interviewed participants perceived multiple benefits in trial enrolment including regular check-ups, provision and explanation of individual test results, the opportunity to ask investigators for advice and the provision of treatment recommendations for those with limited access to a physician outside of the trial. Participants tried to manage risks of trial enrolment by paying attention to how they felt and reporting changes to investigators. Regular monitoring, the opportunity to drop out of the trial and health insurance provision in case of adverse events were viewed as further minimizing individual risks. Importantly, interviewed trial participants did not assess the risks and benefits of a single trial independently of wider social situation or particularities of their own health condition. Value of trial enrolment benefits for participants was enhanced by the healthcare system that was viewed as being unresponsive to the needs of people with cardiovascular disease. Therefore, in their risk-benefit assessment, participants weighed enrolment risks against the risks of dealing with their fragile health without continuous contact with a medical professional. LIMITATIONS: A relatively small number of interviews was conducted, only participants of cardiovascular disease trials were interviewed and the extent to which the described perspectives are generalizable is not established. CONCLUSION: The risk-benefit assessment as performed by most interviewed trial participants involved multiple components, including the ones unrelated to the trial itself, and was largely context-dependent. Perspectives of research participants can enrich frameworks for the evaluation of trial risks and benefits.
Authors: Joyce L Browne; Connie O Rees; Johannes J M van Delden; Irene Agyepong; Diederick E Grobbee; Ama Edwin; Kerstin Klipstein-Grobusch; Rieke van der Graaf Journal: Trop Med Int Health Date: 2019-01-08 Impact factor: 2.622
Authors: Oana P Zaharia; Stefanie Lanzinger; Joachim Rosenbauer; Wolfram Karges; Karsten Müssig; Sebastian M Meyhöfer; Volker Burkart; Michael Hummel; Dirk Raddatz; Michael Roden; Julia Szendroedi; Reinhard W Holl Journal: Front Endocrinol (Lausanne) Date: 2022-06-03 Impact factor: 6.055