AIDS Clinical Trials: Guidelines for Design and Analysis Book

AIDS CLINICAL TRIALS Edited by Dianne M. Finkelstein and David A. SchoenfeldConducting trials for new drugs or regimens for the treatment of HIV or AIDS presents unique challenges to statisticians and clinical investigators. Not only must they have a clear understanding of the relevant regulatory issues and methods of statistical analysis, but they must also deal with various medical and social pressures that further complicate the design and implementation of clinical trials.AIDS Clinical Trials addresses the critical scientific, clinical, and regulatory issues involved in AIDS drug development and evaluation. The book provides the reader with detailed guidelines on the essential statistical methods for data analysis in AIDS clinical trials, and helps foster an understanding of the complex medical and social concerns surrounding AIDS research.The text opens with discussions of the natural history of HIV and its implications for trials, then goes on to offer an overview of the evaluation process for new drugs— considering in depth the perspectives of the pharmaceutical industry and the U.S. Food and Drug Administration. Subsequent chapters in the text deal with specific aspects of planning and conducting AIDS clinical trials, encompassing everything from protocol development and data issues to quality of life, compliance, and economic considerations in AIDS clinical research.Some of the topics covered in the book include: Design and analysis of Phase I and Phase I/II clinical trials in AIDS The uses of CD4 lymphocyte count to evaluate therapy for HIV disease Sample size calculations for failure time data Design and analysis of equivalence trials Testing drug combinations Pediatric, obstetrical, and gynecological issues in AIDS clinical trials Interim monitoring Evaluation of HIV vaccines The use of surveillance and cohort studies for evaluating AIDS therapiesAIDS Clinical Trials is a much needed practical manual on the design and implementation of trials for new drugs designed to treat AIDS and its complications. It is essential reading for all AIDS physicians, biostatisticians, and clinical researchers testing the viability of new treatments— and an ideal resource for statisticians with medical, industrial, or government agencies concerned with evaluating clinical data on the safety and efficacy of prophylactic and therapeutic agents for AIDS/HIV.Read More