Participant Preferences for the Provision of Registration Trials Results

Soichiro Tajima, Akiyo Akaishi, Toshiko Miyamoto, Rumi Katashima, Kenichi Nakai, Takao Mitsui, Hiroaki Yanagawa

Abstract


Background: Clinical trials leading to drug approval (registration trials) play a central role in the drug development process, and attention has recently been paid to providing trial results to participants. In the present study, we examined the preferences of participants of registration trials for the provision of trial-related information.

Methods: We used questionnaires to survey the preferences of registration trial participants at Tokushima University Hospital and Tokushima National Hospital. Of the 15 questions, 6 related to participant characteristics and the trials in which they participated, while 9 questions were concerned with preferences for the provision of information. A five-point scale (strongly agree, agree, neutral, disagree, and strongly disagree) was used, and positive answers (strongly agree and agree) were considered to indicate a positive preference.

Results: Of the 58 subjects, 1 declined, giving a response rate of 98%. More than 70% of participants preferred to obtain information, even if they had served as controls. More than 80% of participants agreed to obtain information relating to trial results, even if the results were negative, and more than 80% of participants agreed to obtain information on the labeling state of the agent, even if development had ceased. Although more than 60% of participants agreed for the provision of information on their allocation and around more than 70% agreed to the provision of information on registration trials status, significantly fewer participants with difficult-to-treat diseases (for example, neurological and malignant diseases) agreed to obtain information compared with participants with other types of diseases (for example, acute, chronic, and psychological diseases). More than 50% of participants desired information to be provided directly by the physician, while a considerable number of participants desired information by means of clinical research coordinators (CRCs) (24.4%) or by posted letter (33.3%).

Conclusion: The present results suggest the preferences for the provision of individual and overall information concerning research results. However, further study is warranted to determine participant preferences more precisely and the effect of the CRC-initiated infrastructure for providing information on patient satisfaction and for promoting registration trials.




doi: http://dx.doi.org/10.4021/jocmr1494w


Keywords


Registration trials; Results; Disclosure; Participants; Preference

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