Reproducible Research

• Activity Number: 256
• Type: Roundtables
• Date/Time: Tuesday, July 31, 2012 : 7:00 AM to 8:15 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Estelle Russek-Cohen*+
• Companies: FDA/CBER
• Keywords: Geonomics ; Clinical Trials ; Personalized medicine

Abstract

There has been a proliferation of journals including those available on-line. In addition, there are appendices offered on-line by major journals so there are fewer limitations on what information can be shared. Funding agencies such as NSF and NIH encourage making study data available. So it is curious that more individuals in the research community aren't revisiting major findings, particularly those that may impact patient care either in the context of a current clinical trial or a future one. NCI held a conference in June of 2011 talking about genomic data and other omics used to develop classifiers to assign patients to treatment in clinical trials and the research motivating the meeting was determined to be faulty and putting patients at risk. Science in December 2011 had an issue devoted to the topic of reproducible research. The purpose of the roundtable is to talk about the challenges of demonstrating reproducibility of research findings so that others may understand or attempt to duplicate the findings particularly when the results may impact clinical trials. This seems critical to the advancement of personalized medicine and high quality science.