Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods

Chapter 55

U.S. Department of Veterans Affairs Cooperative Studies Program

William G. Henderson, Philip W. Lavori, Peter Peduzzi, Joseph F. Collins, Mike R. Sather and John R. Feussner

55.1 Introduction

The Department of Veterans Affairs (VA) is in a unique position in the US, and perhaps the world, in conducting multicenter clinical trials. This is due to several factors: (1) its network of 172 medical centers geographically dispersed throughout the country, under one administrative system; (2) a dedicated group of talented physicians and other health professionals serving at these medical centers; (3) a loyal and compliant patient population of nearly four million veterans; (4) a system of experienced coordinating centers that provide biostatistical, data processing, pharmacy, and administrative support; and (5) a research service that recognizes the uniqueness and importance of the program and strongly supports its mission. The VA has conducted multicenter clinical trials for more than half a century, beginning with its first trial, which was organized in 1945 to evaluate the safety and efficacy of chemotherapeutic agents for tuberculosis. This article describes the history of the program, its organization and operating procedures, some of its noteworthy trials, and current challenges and opportunities.

55.2 History of the Cooperative Studies Program (CSP)

The first cooperative clinical trial conducted by the VA was a joint study with the US Armed Forces to evaluate the safety ...