MAIM
发表于 2025-4-1 02:18:16
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厨师
发表于 2025-4-1 06:38:47
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
含糊
发表于 2025-4-1 13:29:31
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
发表于 2025-4-1 16:55:16
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