The analysis of adverse events (AE) is an essential part of the assessment of safety in the evaluation of new therapies in clinical trials. There is general agreement among stakeholders including regulators, payers, industry, healthcare professionals and patients that improvements in the evaluation of a drug’s safety would benefit all. Although statistical methodologies have advanced, are implemented in standard software (such as R and SAS) and therefore readily available, statistical AE analyses are often too simplistic and therefore potentially misleading. The “Survival analysis for AdVerse events with VarYing follow-up times” (SAVVY) project aims to improve the analyses of adverse event data in clinical trials through the use of survival techniques appropriately dealing with censoring, competing risks (events before AE occurrence) and varying follow-up times. In an empirical meta-analytic study including randomized controlled clinical trials by a number of sponsor companies, the SAVVY project investigates the potential impact that improved AE analyses might have on the conclusion of the safety assessment compared to the current standard of incidence proportions or incidence densities. In this talk, presented on behalf of the SAVVY Study Group, the rationale, statistical concept and some empirical results of the SAVVY project will be presented.
Since January 2010 Tim Friede is Professor of Biostatistics at the University Medical Center Göttingen where he heads up the Department of Medical Statistics. He graduated in Mathematics (Dipl.-Math.) from the University of Karlsruhe and obtained a PhD (Dr.sc.hum.) from the Faculty of Medicine at the University of Heidelberg. In 2001 he joined the Department of Mathematics and Statistics at Lancaster University as NHS Training Fellow in Medical Statistics and was later promoted to Lecturer in Biostatistics. From 2004 he worked for Novartis Pharma AG, Basel before joining Warwick Medical School as Associate Professor of Medical Statistics in October 2006. In 2015 he joined the newly founded Sino-German Institute for Social Computing (SGISC). At the heart of the new Institute of the Universities of Göttingen, Germany and Nanjing, China lies interdisciplinary research on social networks and BIG DATA.
Tim Friede is Section Editor of PLoS ONE as well as Associate Editor of Biometrical Journal and the Annals of Applied Statistics. From 2009 to 2011 he was Editor-in-Chief of the Biometrical Journal jointly with Professor Leonhard Held (Zurich).
Tim Friede’s methodological research interests are in clinical biostatistics including designs for clinical trials (in particular flexible adaptive designs), systematic reviews / meta-analyses (see Systematic Review Unit) and generalized evidence synthesis as well as applications in rare diseases.