Therapeutic Misconception and undue inducement among Patients participating in clinical trials at Moi University clinical Research Center, Eldoret

Abstract

Background: Therapeutic misconception threatens the principles of autonomy and justice as well as the validity of research findings and intent of clinical equipoise. It negatively affects recruitment and retention of potential clinical research participants. The prevalence of therapeutic misconception and undue inducements in western Kenya and how it is affected by recruitment and consenting procedures is not known. Objective: To describe recruitment and consenting process of clinical trials research participants and to determine the prevalence of therapeutic misconception and undue inducement at Moi University Clinical Research Center (MUCRC). Methods: This was a cross sectional study carried out at MUCRC which involved both quantitative and qualitative methods. The study population were all patients who were seeking care at Academic Model Providing Access To Healthcare (AMPATH) and have been enrolled in clinical trials at MUCRC. The semi-structured questionnaire was used. Therapeutic misconception was assessed by evidence of any three of the following elements: participation in research to impress the health care provider (HCP), inability to differentiate between placebo and treatment arms, lack of belief in randomization, lack of clinical equipoise, believe that HCP serve their medical interest. The undue inducement was assessed by presence of at least two of the following elements: Clinical trials’ participant considers transport reimbursement as financial gain/income; could receive better medical care. Quantitative data was entered into Microsoft Access database and analyzed using Stata while qualitative data was manually analyzed per the thematic areas. Data was presented in the form of graphs, pie charts and tables and verbatim. Results: A total of 113 patients participating in clinical trials were sampled. The mean age was 47±8 years and 56 (49.5%) were male. Eighty five (75%) participants were married and 55 (48.7%) had primary level of education. On recruitment characteristics, nine (7.9%) participated in clinical trials once weekly and forty two (37.7%) once monthly. One hundred (89.4%) were participating in clinical trials for the first time. Sixteen (14%) participants could not understand the difference between medical and research procedures, one (0.9%) participated in research to impress the HCP, three (2.7%) could not differentiate research treatment arms, 7 (6%) reported that treatment arm can be changed if it seems to help the other person (lack of randomization), 19 (17%) reported that a HCP always serves their medical interest (lack of clinical equipoise), and 45 (39.8%) could not tell the difference between placebo (control arm) and drug (treatment arm) intervention. All participants felt that they were getting special medical care though they knew they are in a clinical trial, not medical treatment. Half (50.4%) reported that consenting process were handled by clinicians. Two (1.8%) participants felt like withdrawing from the study but not yet decided during the course of this study. The prevalence of therapeutic misconception and undue inducement were 16.8% and 58.4%, respectively. Conclusion: Recruitment procedures involved seeking informed consent in private room and majority 42 (37%) had one clinical trial visit per month. Therapeutic misconception (16.8%) and undue inducement (58.4%) are prevalent among clinical trials research participants in MUCRC. Recommendation: Acceptable standards of research compensation should be implemented to minimize therapeutic misconception and undue inducement.