YSPH / HPM Colloquium in Health Services Research: “Updating Insights into Rosiglitazone and Cardiovascular Risk through Shared Data”

Dr. Wallach’s research focuses on synthesizing, evaluating, and establishing the best evidence to inform research, regulatory, and public health decisions. His primary area of research, known as meta-research (i.e. the study of research itself), includes the key thematic areas of research methodology, reporting/transparency, and reproducibility. His work with the Collaboration for Research Integrity and Transparency (CRIT) at Yale focuses on evaluating the tools, standards, and approaches used to assess the safety, efficacy, quality, and performance of FDA-regulated products.

In this talk, Dr. Wallach will present the results from a comprehensive evaluation of the effects of rosiglitazone therapy on cardiovascular risk and mortality using multiple data sources and varying analytical approaches. In 1999, rosiglitazone was approved in the US for the treatment of type 2 diabetes. Although it was originally a blockbuster drug, rosiglitazone has had a tumultuous history, with cardiovascular safety concerns and numerous regulatory actions. This talk will outline potential methodological, data sharing, clinical, and regulatory implications.