From left, first row: Michael Pencina (Duke), Liz DeLong (Duke), Sara Hughes (GSK), John Whittaker (GSK); From left, second row: Robin White (GSK), Kerry Lee (Duke), Stephen George (Duke), Shein-Chung Chow (Duke), Shuyen Ho (GSK), Steve Novick (GSK), Paul McSorley (GSK), Xiaofei Wang (Duke)

The first GlaxoSmithKline (GSK)-Duke Statistics Workshop on Critical Statistical Issues in Drug Development was held October 29, 2013, at the GSK Research Triangle Park location. It was well attended, with more than 100 participants from both Duke and GSK.

Liz DeLong and Michael Pencina of the Duke Clinical Research Institute and Sara Hughes and John Whittaker of GSK gave opening remarks. Stephen George and Kerry Lee from Duke biostatistics and bioinformatics then presented their perspectives on design and analysis issues in drug development. Finally, Paul McSorley and Steve Novick discussed the GSK data sharing (SHARE) program and challenges and issues involved in pre/nonclinical research.

The Duke Biostatistics and Bioinformatics Department and GlaxoSmithKline formed this partnership with a mission to promote research and collaboration by bringing together researchers from industry, academia, and regulatory agencies to discuss important and potentially controversial issues related to the clinical development of drugs and devices. The partnership also encourages collaboration, consulting, and internships and will include workshops dedicated to important and timely topics in the application of statistics to clinical trials.

The 2nd joint GSK-Duke workshop has been tentatively scheduled for October 28 at Duke.