Data Cleaning Issues — Preparing the Data for the DSMB

How you prepare data for monitoring boards can help streamline your cardiovascular approval or delay the entire process. Biostatistics expert Jørgen Seldrup offers veteran guidance on planning and reporting interim analysis data — with the Data Safety and Monitoring Board (DSMB) in mind. Presented at the December 2009 CVCT Forum in Paris, Jørgen focuses on how to balance the need for data cleaning with the demand for study integrity. In this presentation, you’ll learn the best approach to sharing unblinded data — particularly in event-driven trials.

Download Jørgen’s complete presentation at the CVCT Expert Workshop:

Data Safety and Monitoring Committees (DSMCs) in Cardiovascular Trials

Data Cleaning Issues — Preparing the Data for the DSMB

About the Speaker

Jørgen Seldrup combines deep experience in biostatistics, data monitoring committees and cardiovascular medicine. He serves as Senior Director of Quintiles’ Center for Statistics in Drug Development. As a statistical consultant, he advises on drug development plans, all aspects of clinical trial methodology and regulatory defense cases. He has extensive experience with data monitoring committees and has been the biostatistical voice on several R&D due diligence teams.

A native of Denmark, Seldrup earned his postgraduate degree in statistics from Aarhus University. He started his career as the first statistician at Geigy UK Ltd., but later worked as Director of the Clinical Trials & Epidemiology Research Unit (CTERU) for Singapore’s Ministry of Health.

Jørgen pioneered professionalism in biostatistics — he founded PSI (Statisticians in the Pharmaceutical Industry) in 1977 and served as president of ISCB (International Society for Clinical Biostatistics).