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(Circulation. 2002;106:880.)
© 2002 American Heart Association, Inc.

Clinical Cardiology: New Frontiers

Lessons Learned From Recent Cardiovascular Clinical Trials: Part II

David L. DeMets, PhD; Robert M. Califf, MD

From the Duke Clinical Research Institute and the Division of Cardiology (R.M.C.), Duke University Medical Center, Durham, NC, and the Department of Biostatistics and Medical Informatics (D.L.D.), University of Wisconsin, Madison, Wis.

Correspondence to Robert M. Califf, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715. E-mail calif001@mc.duke.edu

Key Words: trials • cardiovascular diseases • therapy • outcome assessment • statistics

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
In this second part of a 4-part series about clinical research, we will complete the lessons we have learned during the past 2 decades from our involvement in cardiovascular clinical trials. The final 2 articles will delve into principles we have derived from our lessons that are meant to help practicing clinicians incorporate good clinical trial results into their patient care.

	Structural Issues in the Conduct of Trials

 
The present structure for administering multicenter clinical trials funded by the government was established by the Greenberg Report¹ and first implemented by the Coronary Drug Project.² Referred to as the National Institutes of Health (NIH) clinical trial model (Figure 1), this example became the standard for trials sponsored by the National Heart, Lung and Blood Institute (NHLBI) and by many other NIH institutes.³ Key components of this model include the sponsoring agency, steering committee, data coordinating center, and data monitoring committee (DMC). The steering committee usually is made up of a study chair and other selected (or elected) representatives from the investigators and sponsor. Steering committee members develop the protocol, lead the trial, and publish the results when the trial is completed. The data coordination center is responsible for the management and quality control of the trial data, as well as for interim or final analyses of the baseline, safety, and efficacy data.

View larger version (22K): [in this window] [in a new window]   Figure 1. Clinical trial model that evolved through experience at the National Institutes of Health. Reprinted with permission from Fisher M, Roecker E, DeMets D. The role of an independent statistical analysis center in . . . [Full Text of this Article]

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