2130The patient in clinical research: disposable guinea pig or involved actor?

Abstract

Abstract Background The request for informed consent to join a clinical trial often creates mistrust and hesitation in the patient who should be enrolled. Methods In the last ten years of cardiovascular clinical research we asked an informed consent to 2,586 patients. 59% agreed to join clinical trials, 40% refused. The 1% initially accepted and then withdrew the consent. We asked all the patients who refused the consent to answer a brief interview about the reasons for rejection. Patients who refused to join clinical trials were relatively young (mean age 62±5) and had a high level of education; 619 (60%) had a high school diploma or a degree. Results Of 1031 patients, 629 (61%), accepted to answer the interview; 176 (28%) answered they refused on relatives', friends' or other doctors' advices, or after Internet searches; 157 (25%) answered they didn't agree about how the trials were carried out (double blind control procedure, use of placebo, ecc); 126 (20%) didn't trust official medicine. 63 (10%) couldn't guarantee their presence at the controls. 69 (11%) didn't want to undergo additional medical examinations. 31 (5%) had previous bad research experiences (feeling like a guinea pig, ecc). 7 (about 1%) refused for other reasons. Table 1. Acceptance or refusal to join cardiological intervention or observational clinical trials in the last 10 years Informed consent Immediately after reading and Principal Investigator's explanation After discussion with family, GP or Internet searches Total Accepted 914 (35%) 608 (24%) 1522 (29%) Initially accepted with subsequent withdrawal before randomization 1 (0.03%) 30 (1.2%) 31 (1%) Initially accepted with subsequent withdrawal after randomization 0 2 (0.07%) 2 (0.07%) Refused 151 (6%) 880 (34%) 1.031 (40%) Total 1.066 (41%) 1.520 (59%) 2.586 (100%) Conclusions Recruitment into clinical research studies is still a major challenge; patients are not fully aware of the importance of participation in clinical research studies for the development and implementation of medical advances. Paradoxically, people who refuse to participate in a trial are young and have a high level of education. Researcher's duty is to involve the patient in the trial and clarify the benefits of join the research.