The next frontier: Fostering innovation by improving health data access and utilization

Eric NormanArticles

Clinical Pharmacology & Therapeutics, November 1, 2015
A. Oye, G. Jain, M. Amador, R. Arnaout, J. S. Brown, W. Crown, J. Ferguson, E. Pezalla, J. A. Rassen, H. P. Selker, M. Trusheim, and G. Hirsch

Beneath most lively policy debates sit dry-as-dust theoretical and methodological discussions. Current disputes over the EU Adaptive Pathways initiative1, 2 and the proposed US 21st Century Cures Act3 may ultimately rest on addressing arcane issues of data curation, standardization, and utilization. Improved extraction of information on the safety and effectiveness of drugs-in-use must parallel adjustments in evidence requirements at the time of licensing. To do otherwise may compromise safety and efficacy in the name of fostering innovation.

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