Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable.

Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has held faculty appointments at six different universities.    Dr. Rockhold served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials and a past member of the PCORI Clinical Trials Advisory Panel. He is currently Chair of the Board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.

Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.    Frank is widely published in major scientific journals across a wide variety of research topics.

Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, a Fellow of the Royal Statistical Society, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.  

Dr. Tenenbaum is a faculty member in the Division of Translational Biomedical Informatics in the Department of Biostatistics and Bioinformatics. Her primary research interests are  1. Informatics to enable precision medicine; 2. Mental health informatics; 3. Infrastructure and standards to enable research collaboration and integrative data analysis; and 4. Ethical, legal, and social issues that arise in translational research, direct to consumer genetic testing, and data sharing. Current research projects focus on analyzing electronic health record data to better understand mental illness, target resource allocation, guide treatment, and develop targeted therapeutic interventions.

Nationally, Dr. Tenenbaum plays a leadership role in the American Medical Informatics Association, serving as Chair of the Mental Health Informatics Working Group and as an elected member of the Board of Directors. She is an Associate Editor for the Journal of Biomedical Informatics and served on the advisory panel for Nature Publishing Group's Scientific Data initiative.  After earning her bachelor’s degree in biology from Harvard, Dr. Tenenbaum worked as a program manager at Microsoft Corporation in Redmond, WA for six years before pursuing a PhD in biomedical informatics at Stanford University.

Dr. Marsolo is a faculty member in the Department of Population Health Sciences (DPHS) and a member of the Duke Clinical Research Institute (DCRI).  His current research focuses on infrastructure to support the use of electronic health records (EHRs) and other real-world data sources in observational and comparative effectiveness research and public health surveillance, as well as standards and architectures for multi-center learning health systems.  He serves as faculty advisor to the DPHS DataShare Shared Facility and faculty lead for the Pragmatic Health Services Research (PHSR) functional group within the DCRI.  Dr. Marsolo received his PhD in Computer Science from The Ohio State University, with a dissertation on data mining, specifically the modeling and classification of biomedical data. 

Dr. Emily O’Brien is Associate Professor in Population Health Sciences, Associate Professor in Neurology, Core Faculty Member at Duke-Margolis Center for Health Policy,  and Co-Director of Population Health Sciences at the Duke Clinical Research Institute. Her research focuses on comparative effectiveness, patient-centered outcomes, and pragmatic health systems research in cardiovascular and pulmonary disease. Her areas of expertise include: Epidemiology, Pragmatic Clinical Trials, and Clinical Decision Sciences. Dr. O’Brien received her PhD in Epidemiology from the University of North Carolina in Chapel Hill. As principal investigator for projects funded by the FDA, NIH, and PCORI, she has extensive experience working with diverse data sources including registries, epidemiologic cohorts, electronic health records, and administrative claims data. Dr. O’Brien teaches Analytic Methods in the Department of Population Health Sciences PhD program and has co-authored over 160 manuscripts in peer-reviewed journals on topics ranging from epidemiologic methods, comparative effectiveness, and pragmatic clinical trials. She is an associate editor for Circulation: Cardiovascular Quality and Outcomes, Chair of the AHA QCOR Scientific & Clinical Education Lifelong Learning Committee, social media editor for the Journal of the American Heart Association, and a fellow of the American Heart Association.