Design Considerations for AIDS Trials

David P. Byar, David A. Schoenfeld, Sylvan B. Green, David A. Amato, Roger Davis, Victor de Gruttola, Dianne M. Finkelstein, Constantine Gatsonis, Richard D. Gelber, Stephen Lagakos, Myrto Lefkopoulou, Anastasios A. Tsiatis, Marvin Zelen, Julian Peto, Laurence S. Freedman, Mitchell Gail, Richard Simon, Susan S. Ellenberg, James R. Anderson, Rory CollinsRichard Peto, Tim Peto

Research output: Contribution to journalEditorial

126 Scopus citations


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…

Original languageEnglish
Pages (from-to)1343-1348
Number of pages6
JournalNew England Journal of Medicine
Issue number19
StatePublished - 8 Nov 1990
Externally publishedYes


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