Initiating Clinical Trials

A Case Study of a Proposed Clinical Trial for Acute Myocardial Infarction

by Glenn T. Hammons, James P. Kahan

Purchase Print Copy

 FormatList Price Price
Add to Cart Paperback36 pages $20.00 $16.00 20% Web Discount

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.

This report is part of the RAND Corporation Note series. The note was a product of the RAND Corporation from 1979 to 1993 that reported other outputs of sponsored research for general distribution.

Our mission to help improve policy and decisionmaking through research and analysis is enabled through our core values of quality and objectivity and our unwavering commitment to the highest level of integrity and ethical behavior. To help ensure our research and analysis are rigorous, objective, and nonpartisan, we subject our research publications to a robust and exacting quality-assurance process; avoid both the appearance and reality of financial and other conflicts of interest through staff training, project screening, and a policy of mandatory disclosure; and pursue transparency in our research engagements through our commitment to the open publication of our research findings and recommendations, disclosure of the source of funding of published research, and policies to ensure intellectual independence. For more information, visit

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.