CLINICAL TRIALS
THE AGGREGATE SAFETY ASSESSMENT PLAN A valuable tool for clinical trial safety planning The Drug Information Association / American Statistical Association Interdisciplinary Safety Evaluation working group has proposed an Aggregate Safety Assessment Plan (ASAP). The ASAP promotes a consistent approach to safety data collection and analyses across studies. The ASAP is a valuable tool for sponsors to enhance characterisation of the emerging product safety profile. Barbara A Hendrickson, Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie
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ecently, a Drug Information Association / American Statistical Association-sponsored Interdisciplinary Safety Evaluation working group published a recommended approach to the aggregate assessment of clinical trial safety data. The proposed Aggregate Safety Assessment Plan (ASAP) has several components including identification of the safety topics of interest, how the safety data will
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P H A RM A F O C U S A S I A
ISSUE 46 - 2022
