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Abstract:
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Regulatory agencies have issued guidance for evaluating the long-term cardiovascular (CV) safety of new anti-diabetes therapies to ensure that the new therapies do not increase CV risk to an unacceptable extent. Different strategies to address pre-marketing and post-marketing CV risk requirements have been proposed and implemented. Cardiovascular outcome trials (CVOTs) provide an opportunity to evaluate safety signals beyond CV risk and better assess the benefit-risk profile in diabetic patients with a high risk for CV events, but they also present numerous challenges. Key statistical issues and challenges encountered at the design and analysis stages of CVOTs include complex multiplicity scenarios, how to address pre-marketing and post-marketing requirements efficiently; design of CVOT for non-inferiority and superiority testing; subgroup analysis and patient retention and missing data. In this presentation, I will share work of the American Statistical Association Biopharmaceutical Section Safety Working Group on these issues and discuss solutions to address these challenges.
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