Emmi Reijula1, Arja Halkoaho2, Anna-Maija Pietilä3, Tuomas Selander4, Kirsti Martikainen5, Reetta Kälviäinen6, Tapani Keränen7. 1. The University of Eastern Finland, Faculty of Health Sciences, Kuopio University Hospital's Science Service Center, Kuopio, Finland. Electronic address: emmi.reijula@gmail.com. 2. Kuopio University Hospital's Science Service Center, Kuopio, Finland. Electronic address: arja.halkoaho@kuh.fi. 3. The University of Eastern Finland, Faculty of Health Sciences, Kuopio Social and Health Care Services, Kuopio, Finland. Electronic address: anna-maija.pietila@uef.fi. 4. Kuopio University Hospital's Science Service Center, Kuopio, Finland. Electronic address: tuomas.selander@kuh.fi. 5. The Finnish Parkinson Association, Turku, Finland. Electronic address: kirsti.martikainen@fimnet.fi. 6. NeuroCenter at Kuopio University Hospital, Faculty of Health Sciences, School of Medicine, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland. Electronic address: reetta.kalviainen@kuh.fi. 7. Kuopio University Hospital's Science Service Center, Kuopio, Finland; Department of Neurology, Kanta-Häme Central Hospital, Hämeenlinna, Finland. Electronic address: tapani.keranen@uef.fi.
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.
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 epilepsypatients 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.