Initiating Clinical Trials

This Note describes the development of a grant application submitted to the National Institutes of Health proposing a randomized controlled trial to assess the comparative effectiveness of continued care in a coronary care unit (CCU) vs. care in a monitored hospital bed after 24 hours in a CCU for uncomplicated acute myocardial infarction, and the review and recommendation for disapproval of the application by the Clinical Trials Review Committee (CTRC) of the National Heart, Lung, and Blood Institute. The reasons for the recommendation for disapproval of the application by the CTRC were determined and are analyzed in the context of proposed clinical trials of current medical practices. The case study led to the following conclusions: (1) The effectiveness of intensive care for uncomplicated acute myocardial infarction has never been rigorously evaluated despite the importance and expense of this medical practice. (2) Flaws in the design of the study and incomplete preparation by the investigators led to disapproval of the proposal. (3) Clinical trials, and especially randomized clinical trials of current medical practices that are widely accepted by the medical community, will be difficult to carry out.