Abstract:
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The 2015 draft guidance on the FDA IND safety reporting final rule states that sponsors should periodically review accumulating safety data collected across multiple studies (completed and ongoing), analyze the data in the aggregate, and make a judgment about the likelihood that the drug caused any SAEs. Ongoing review of aggregate clinical trial safety data is a collaborative process, which requires dynamic, interactive collaboration among Safety, Clinical, Epidemiology, and Statistics. Quantitative frameworks can be designed to help multi-disciplinary Safety Management Teams (SMTs) to judge the strength of evidence contained in data from ongoing blinded studies and completed unblinded studies, to stimulate their discussion and to improve their evaluations of the accumulating data. SMTs will be able to continuously evaluate evidence of relative risk elevation using measures of evidence in the accumulating data, in combination with other available information, to make fully informed decisions that protect patients from unnecessary harm while allowing the trials to lead to conclusive results.
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