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

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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