Public involvement in the design and conduct of clinical trials: A narrative review of case examples

2012 Conference

Abstract:
Clinical trials test the effectiveness of health care interventions. The public should be actively involved in the design and conduct of clinical trials. We searched the literature to find examples of public involvement in the design and conduct of individual clinical trials. This presentation describes how the public were involved in the nine trials we identified through our literature search. We found that the public contributed to the design of trials by:

• reviewing consent procedures and patient information sheets
• suggesting additional trial outcomes
• reviewing a trial’s data collection procedures
• making recommendations on the timing and location of follow-up data collection.

We found that the public can contribute to the conduct of clinical trials through membership of the Trial Steering Committee and by delivering the trial protocol after completing relevant training. We will discuss the concerns that researchers have raised about public involvement in the design and conduct of trials, as well as the good practice recommendations that have been put forward. This presentation will provide important evidence for researchers, the public and funders on how the public can make substantial contributions to the design and conduct of clinical trials.

I would like to acknowledge the contributions of Wendy Baird (Director of the NIHR Research Design Service for Yorkshire and the Humber) and Anthea Sutton (Information Specialist, University of Sheffield) to this work.