Design Considerations for AIDS Trials

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Abstract
Statisticians and clinicians involved in the design and conduct of trials of new treatments for the acquired immunodeficiency syndrome (AIDS) have realized that some traditional approaches to the clinical-trials process may be unnecessarily rigid and unsuitable for this disease.1 A new and rapidly growing epidemic, affecting relatively young people, produces a particular sense of urgency. Many agents for the treatment of AIDS and human immunodeficiency virus (HIV) infection are becoming available for testing, including vaccines, antiviral drugs, immunostimulant agents, and drugs to prevent or treat opportunistic infections. Past success with other major infectious diseases leads to community expectations of a . . .