Comparable indicators of therapeutic misconception between epilepsy or Parkinson's disease patients between those with clinical trial experience and trial non-participants

Abstract

Purpose: Study design, personal persuasions, and experiences can influence willingness to participate in clinical trials (CTs). A study assessed differences between Parkinson's disease (PD) or epilepsy patients having participated in CTs and non-participants in knowledge of and attitudes toward CTs. Also considered were factors in willingness to take part and how CT participants experienced the informed consent process.

Method: Random samples of members of Finland's PD (n = 2000) and epilepsy (n = 1875) patient organisations were posted a questionnaire on their views about CTs. Of the 1050 questionnaires returned, 845 met inclusion criteria. In total, 126 had participated in CTs.

Results: While over 90% of respondents knew that participation is always voluntary, CT participants were more often aware that one can withdraw (p<0.001). In both groups, most did not recognise the possibility of randomisation, and 57% in both CT participants and non-participants indicated that CTs are aimed primarily at seeking the best medication for the participant. Nevertheless, 83% of CT participants indicated ability to understand the information provided.

Conclusions: While most in our study agreed that patients should be asked to participate in CTs, only 15% of subjects had done so. The discrepancy between willingness to participate and recruitment figures could be minimised by improving knowledge of CTs and communication between patients and researchers. Additionally, the groups displayed comparable false CT-related assumptions, raising questions about whether these subjects fully understood the clinical research's ultimate goal and CT participants had given true informed consent. These issues have practical and ethics implications for clinical investigators.

Keywords: Clinical trials; Epilepsy; Informed consent process; Parkinson’s disease; Therapeutic misconception; Trial participation.