A Model for Dissemination and Independent Analysis of Industry Data
JAMAPublished 12 October 2011Open access
Harlan M. Krumholz, Joseph S. Ross
Citations43
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Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
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TL;DR
Current clinical research standards lack sufficiently strong requirements for transparency and availability, and there are no uniform international standards requiring that study protocols, statistical analysis plans, and study results be made available, nor that completed clinical trial data be posted for independent analysis.
Keywords
MathematicsEconomics, Econometrics and FinancePharmacology, Toxicology and Pharmaceutics
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