Statistical Issues Arising in AIDS Clinical Trials
作者:
SusanS. Ellenberg,
DianneM. Finkelstein,
DavidA. Schoenfeld,
期刊:
Journal of the American Statistical Association
(Taylor Available online 1992)
卷期:
Volume 87,
issue 418
页码: 562-569
ISSN:0162-1459
年代: 1992
DOI:10.1080/01621459.1992.10475240
出版商: Taylor & Francis Group
关键词: Acquired immune deficiency syndrome;Clinical trials;Human immunodeficiency virus
数据来源: Taylor
摘要:
In the 11 years since AIDS became a defined disease, programs for the development and evaluation of new drugs for this disease have grown rapidly. Although the fundamental principles that drive the design, conduct, and analysis of clinical trials are as applicable to AIDS as to other diseases, there is no question that we have been confronted with unusually difficult challenges in studying therapeutic approaches for this disease. These include the multiple treatment needs of individual patients, identification of appropriate endpoints, rapidly changing “natural history,” and the need for interaction with an informed and vocal patient community that continues to express dissatisfaction with the pace of research. In this context, statisticians have taken a leadership role in identifying and addressing important methodological issues in the evaluation of AIDS drugs.
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