Year: 2015
Type: article
Abstract: Beneath most lively policy debates sit dry-as-dust theoretical and methodological discussions. Current disputes over the EU Adaptive Pathways initiative and the proposed US 21st Century Cures Act may ultimately rest on addressing arcane issues of data curation, standardization, and utilization. Improved extraction of inform ation 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.
DOI: 10.1002/cpt.191
Authors: KA Oye, G Jain, M Amador, R Arnaout, JS Brown, W Crown, J Ferguson, E Pezalla, JA Rassen, HP Selker, M Trusheim, G Hirsch
Institutions: Massachusetts Institute of Technology, International Risk Governance Council, Beth Israel Deaconess Medical Center, Harvard University, Harvard Pilgrim Health Care, Shire (United States), Aetna (United States), Aetion (United States), Tufts University, Tufts Medical Center, Tufts Clinical and Translational Science Institute
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: hybrid
Estimated APC paid: $4,410
OpenAlex ID: W2129286577