OBJECTIVE: To assess the extent to which consumers are involved in the work of clinical trial coordinating centres in the United Kingdom and the nature of consumers' involvement in randomised trials coordinated by these centres. DESIGN: National surveys using structured questionnaires with some open ended sections. SETTING: 103 clinical trial coordinating centres in the United Kingdom identified through a database assembled in 1997 by the NHS clinical trials adviser. PARTICIPANTS: Named contacts at 62 coordinating centres and investigators in 60 trials that were identified as involving consumers. MAIN OUTCOME MEASURES: Number of coordinating centres and number of trials in which consumers were involved and the nature of consumers' involvement. RESULTS: Of the 62 eligible centres, 23 reported that consumers had already been involved in their work, and most respondents were positive about this involvement. 17 centres planned to involve consumers. 15 centres had no plans to involve consumers, but only four of these considered such involvement irrelevant. Responses from investigators about the 48 individual trials were mostly positive, with respondents commenting that input from consumers had helped refine research questions, improve the quality of patient information, and make the trial more relevant to the needs of patients. CONCLUSIONS: Consumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials.
OBJECTIVE: To assess the extent to which consumers are involved in the work of clinical trial coordinating centres in the United Kingdom and the nature of consumers' involvement in randomised trials coordinated by these centres. DESIGN: National surveys using structured questionnaires with some open ended sections. SETTING: 103 clinical trial coordinating centres in the United Kingdom identified through a database assembled in 1997 by the NHS clinical trials adviser. PARTICIPANTS: Named contacts at 62 coordinating centres and investigators in 60 trials that were identified as involving consumers. MAIN OUTCOME MEASURES: Number of coordinating centres and number of trials in which consumers were involved and the nature of consumers' involvement. RESULTS: Of the 62 eligible centres, 23 reported that consumers had already been involved in their work, and most respondents were positive about this involvement. 17 centres planned to involve consumers. 15 centres had no plans to involve consumers, but only four of these considered such involvement irrelevant. Responses from investigators about the 48 individual trials were mostly positive, with respondents commenting that input from consumers had helped refine research questions, improve the quality of patient information, and make the trial more relevant to the needs of patients. CONCLUSIONS: Consumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials.
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Keywords:
Biomedical and Behavioral Research; Empirical Approach