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 Collins; Richard Peto; Tim Peto

doi:10.1056/nejm199011083231912

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 journal › Editorial

128 Scopus citations

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…

Original language	English
Pages (from-to)	1343-1348
Number of pages	6
Journal	New England Journal of Medicine
Volume	323
Issue number	19
DOIs	https://doi.org/10.1056/nejm199011083231912
State	Published - 8 Nov 1990
Externally published	Yes

Funding

Funders	Funder number
National Institute of Allergy and Infectious Diseases	N01AI095030

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Byar, D. P., Schoenfeld, D. A., Green, S. B., Amato, D. A., Davis, R., de Gruttola, V., Finkelstein, D. M., Gatsonis, C., Gelber, R. D., Lagakos, S., Lefkopoulou, M., Tsiatis, A. A., Zelen, M., Peto, J., Freedman, L. S., Gail, M., Simon, R., Ellenberg, S. S., Anderson, J. R., ... Peto, T. (1990). Design Considerations for AIDS Trials. New England Journal of Medicine, 323(19), 1343-1348. https://doi.org/10.1056/nejm199011083231912

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title = "Design Considerations for AIDS Trials",

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…",

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

year = "1990",

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day = "8",

doi = "10.1056/nejm199011083231912",

language = "אנגלית",

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Byar, DP, Schoenfeld, DA, Green, SB, Amato, DA, Davis, R, de Gruttola, V, Finkelstein, DM, Gatsonis, C, Gelber, RD, Lagakos, S, Lefkopoulou, M, Tsiatis, AA, Zelen, M, Peto, J, Freedman, LS, Gail, M, Simon, R, Ellenberg, SS, Anderson, JR, Collins, R, Peto, R & Peto, T 1990, 'Design Considerations for AIDS Trials', New England Journal of Medicine, vol. 323, no. 19, pp. 1343-1348. https://doi.org/10.1056/nejm199011083231912

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AU - Amato, David A.

AU - Davis, Roger

AU - de Gruttola, Victor

AU - Finkelstein, Dianne M.

AU - Gatsonis, Constantine

AU - Gelber, Richard D.

AU - Lagakos, Stephen

AU - Lefkopoulou, Myrto

AU - Tsiatis, Anastasios A.

AU - Zelen, Marvin

AU - Peto, Julian

AU - Freedman, Laurence S.

AU - Gail, Mitchell

AU - Simon, Richard

AU - Ellenberg, Susan S.

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AU - Collins, Rory

AU - Peto, Richard

AU - Peto, Tim

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Design Considerations for AIDS Trials

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