Evaluating patients' approach toward participation in a clinical trial: A multicentric study

Clinical trial enrollment remains a challenge as participants have their viewpoints. The study aims to determine the perception of awareness and interest in participation in clinical trials and the reasons for acceptance or declining participation among outpatient department patients.

The study is a prospective questionnaire-based survey of 500 participants from two centers. The questionnaire consisted of three items on awareness regarding clinical trials and 16 items assessing factors affecting participation, with responses recorded in a 3-point Likert scale. The associations between demographic factors, awareness about clinical trials, and interest in participation in clinical trials were evaluated using the univariate model. P < 0.05 were considered to be significant.

The study found that the participants were unaware of the clinical trial (87%), and most study participants had not participated in the clinical trial (99%). Most participants said they would not like to participate (76%) in the clinical trial if given an opportunity. The major reasons for participation identified were that research benefits society (89%), advances medical science (90%), and medicines and investigations will be provided free of cost (88%). The major reasons for nonparticipation were the fear of the side effects of the drug (83%), repeated visits would cause inconvenience (87%), and consume time (86%). The demographic factors that determined awareness regarding clinical trials were lower age (P = 0.0001), higher education levels (P = 0.0001), and higher socioeconomic classes (P = 0.0000). A significantly greater number of participants with lower education levels were associated with lower interest in participation in clinical trials (P = 0.0004).

Our findings provide valuable insights into the public's awareness of clinical trials. The public's awareness and willingness to participate in clinical trials in India are relatively low and significantly influenced by their education and socioeconomic status. Scientific outreach initiatives to spread clinical trials-related knowledge in the future are crucial.