Open science is good for researchers, good for innovation, and good for public health.
Clinical research generates tremendous amounts of valuable data. However, for decades, this priceless information has been largely unavailable to the wider community of researchers and its full benefit has gone unrealized. By unlocking these vast storehouses of data, we open a new world of possibilities in which the search for new treatments is accelerated and a better understanding of human health and illness is within reach.
The question at the center of the open-science discussion is not whether data should be shared, but how we can develop responsible methods for doing so. Our collaboration with partners in industry, academia, and other spheres will allow data to be shared in ways that can improve public health worldwide.
Michael J. Pencina, PhDDirector of Biostatistics
DCRI and SAS Support Open Science
This collaboration gives more researchers access to the largest and longest-running cardiovascular database in the world. The DCRI and analytics leader SAS provide researchers worldwide with data management and analytics tools to explore 45 years of cardiovascular patient data collected by the Duke University Health System.
Working Together to Open Clinical Trial Data
DCRI Executive Director Eric Peterson, MD, MPH, and Director of Biostatistics Michael Pencina, PhD, discuss the DCRI’s recent partnership with SAS to promote open access to clinical trial data.
A Critical Juncture for Clinical Data Sharing
Sharing data from clinical trials can produce new insights, establish credibility and honor the contributions of participating patients if researchers answer questions about what gets shared and change attitudes by addressing concerns about how to share responsibly, writes Frank Rockhold, PhD, professor of biostatistics and bioinformatics, in For The Record magazine.
Collaboration: ACCESS CV
The Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies—Cardiovascular (ACCESS CV) was formed to create a strategy to thoughtfully operationalize the recommendations of the International Committee of Medical Journal Editors (ICMJE) and the Institute of Medicine (IOM) for sharing of clinical trial data. The ACCESS CV consortium partners broadly support the concepts of data transparency and open access. The benefits of sharing patient-level data from clinical trials include confirmation of results, opportunities for new discoveries from secondary analyses, and eventually allowing aggregation of data sets from related studies to facilitate high-quality systematic meta-analyses.
Frank Rockhold, PhD, professor of biostatistics and bioinformatics
Frank Rockhold, PhD, is a professor of biostatistics and bioinformatics at the DCRI. A leading biostatistician in the pharmaceutical industry, Rockhold has more than 30 years of diverse experience in clinical trial design, data monitoring, decision sciences, statistical research, and epidemiology.
Rockhold was most recently senior vice president of Global Clinical Safety and Pharmacovigilance at GlaxoSmithKline, and prior to that ran Cardiovascular and Metabolic Development and the Biostatistics, Epidemiology and Healthcare Informatics departments. Earlier in his career, he held positions with Merck Research Laboratories and Lilly Research Laboratories.
He served on the board of directors of the Clinical Data Interchange Standards Consortium, most recently as Chairman, is past president of the Society for Clinical Trials, is a fellow of both the American Statistical Association and the Society for Clinical Trials, and is an accredited professional statistician. Rockhold received his PhD in biostatistics from the Medical College of Virginia, his ScM in biostatistics from The Johns Hopkins University, and his BA in statistics from the University of Connecticut.