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Big Data in Clinical Research: Standing Room only for Janice Pogue Lecture

The 3rd annual Janice Pogue Lectureship drew large crowds to PHRI on March 18, 2019, who came to hear Prof. Lisa LaVange, PhD, Associate Chair, Department of Biostatistics, the Gillings School of Global Public Health, the University of North Carolina at Chapel Hill (UNC), speak on the topic of Opportunities and Challenges in Clinical Research with the Use of Big Data and Novel Trial Designs.

Prof. LaVange observed that the research landscape is changing in two important ways. First, there is a greater need to understand and process large, complex datasets from sources of varying quality. The availability of new data sources offer several advantages to clinical research, but an understanding of the limitations of their use is also needed. Second, recent advances in precision medicine have necessitated the use of complex innovative trial designs to fully realize the potential of targeted therapies.

With the challenges posed by non-standard data sources and non-traditional trial designs, statisticians have an increasingly important role to play to ensure the research findings are based on valid inference and are reproducible and interpretable, LaVange said. Opportunities for collaboration and innovation are illustrated with examples from different sectors.

Lisa LaVange is also director of the department’s Collaborative Studies Coordinating Center (CSCC), overseeing faculty, staff, and students involved in large-scale clinical trials and epidemiological studies coordinated by the center. From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). There, she oversaw more than 200 statisticians and other staff members involved in the development and application of statistical methodology for drug regulation. She was a leader in developing and assessing the effectiveness and appropriateness of innovative statistical methods intended to accelerate the process from drug discovery to clinical trials to FDA approval and patients’ benefit, with a particular focus on rare diseases. Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. She is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President.

This lectureship honours the late Janice Pogue, an exceptional statistician who created the statistical group at the Population Health Research Institute where she worked for 22 years. [Read the PHRI-authored Janice Pogue obituary in Clinical Trials.]

L to R: PHRI Executive Director Salim Yusuf; Prof. Lisa LaVange; PHRI investigator Jackie Bosch; Janice Pogue’s son, CK, and husband, David.