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S33: Spotlight on Rigorous Study Design, Reproducibility and Transparent Reporting

12:15 - 13:15, Brickell, Terrace Level

Emmeline Edwards (1), David Shurtleff (1), Carol Pontzer (1)

(1): National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM), United States   


Developing effective complementary and integrative interventions for symptom management is central to the mission of the National Center for Complementary and Alternative Integrative Medicine (NCCAM). To accomplish its mission NCCAM relies on, and supports a diverse preclinical and clinical research grant portfolio.  The reproducibility of such research, however, has been questioned and, most recently, the spot-light has been on the irreproducibility of pre-clinical research.  This session will highlight these concerns, the likely causes, and provides possible solutions for improving the design, execution and reporting of pre-clinical studies, basic human mechanistic studies, and Phase I clinical studies that serve as the foundation for translating basic research discoveries into improved clinical practice and health.  Dr. David Shurtleff will summarize recent concerns and possible causes for pre-clinical research irreproducibility.  He will describe steps the National Institutes of Health and other organizations, such as scientific journal publishers, are taking to address this problem.  Dr. Emmeline Edwards will discuss the need for a core set of reporting standards for basic human mechanistic studies with a special emphasis on data handling. She will highlight practices related to data handling that can lead to false positives, such as interim data analysis, ad hoc exclusion of data, retrospective primary end-point selection, sample size determination and adequacy of control conditions. Dr. Carol Pontzer, will describe some negative and inconclusive NCCAM sponsored natural products intervention trials to exemplify the importance of rigorous foundational research, evaluation of scientific premise, and analysis and interpretation of clinical trials data.  She will also comment on efforts by scientific journals and reviewers to ensure quality of publications through the enhancement of review guidelines.