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Abstract:
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In pharmaceutical industry, statisticians typically focus on the efficacy data in study design and monitoring, while medical monitors and pharmacovigilance colleagues are responsible for safety data interpretation. In contrast to the close collaboration between statisticians and medical colleagues in efficacy data interpretation and trial monitoring, safety data interpretation is usually not considered in statistician’s domain, which is largely due to inadequate medical training for statisticians. However, with complex correlations and confounding effects among safety data, there is a clear need for more sophisticated statistical handling beyond the frequency summary to improve understanding and monitoring of safety data. Adequate understanding of safety data is crucial not only for the benefit-risk assessment for a medical product, but also for patients, health care providers and payers in clinical practice. Recently, innovative statistical methods appeared in handling safety data. In this roundtable session, I’d like to discuss with colleagues and researchers about the challenges and opportunities in support of safety analysis and monitoring in clinical trials.
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