Abstract
BackgroundThe rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics.MethodsA Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial.ResultsA total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively).ConclusionPrevious and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.
Highlights
The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess
Design and validation of the survey We report the second section of a multicenter survey on clinical trial perceptions, which focused on ethical compliance and protection issues of industry-sponsored research trials (ISRT), along with the overall perception of participating in a trial
Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively), the time research physicians took to explain the research study (41.2 and 54%, respectively), the researcher or staff availability (23.7 and 74%, respectively) the sense of humanity of the research physician (22 and 77.2%, respectively), and the outcomes obtained through the medical care received (23.8 and 73.5% respectively). In this multicenter, cross-sectional, comparative survey study conducted in a developing country, participants of ISRT were more aware than controls of the responsibility and function of the Ethics committees (EC) in pharmaceutical industry trials, the higher quality of their medical services and the researcher’s physicians, the protection by the EC, safety and overall satisfaction during protocol participation, and the reasons behind economical reimbursement
Summary
The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. In the last 10 years, clinical trial registry in González-Saldivar et al BMC Medical Ethics (2019) 20:2 the large populations interested in protocol participation as an alternative for their health care. The rapid increase of ISRT in developing countries has led to potential complex ethical issues and cases of researcher misconduct [1]. Widespread poverty, lack of education and very limited access to good-quality health services in many developing countries make the ethical conduction process of these protocols uncertain, during recruitment and informed consent (IC) phases [1]. Even though some studies have assessed the opinion of experts regarding these topics, there is a paucity of evidence concerning the participant’s perception [9–11]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
