Titlebook: Data Monitoring in Clinical Trials; A Case Studies Appro David L. DeMets,Curt D. Furberg,Lawrence M. Friedm Book 2006 Springer-Verlag New Y

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Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Resultsducing overall mortality, thus vindicating the recommendations of the DSMB to keep the trial open until the planned follow-up had been completed. This paper is a review of the DSMB process for this study, and how the Board dealt with the challenges of interpretation of apparently contradictory evide

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Challenges in Monitoring the Breast Cancer Prevention Trial multiple endpoints of interest, other concerns that were addressed included a reassessment of study sample size and power subsequent to a lengthy suspension of accrual during the trial and handling the occurrence of an unexpected ocular toxicity in association with tamoxifen. Although there were nu

Individual

Data Monitoring Experience in the Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Farst was to review all reported Serious Adverse Events (SAEs) on a monthly basis and produce a short report to the sponsor aimed for regulatory agencies. This was done because the sponsor had received a waiver for expedited reporting of SAEs from regulatory agencies including the U.S. Food and Drug A