Data from: Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

Jennifer E. Miller, David Korn & Joseph S. Ross
Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design: Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources: Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome...

Registration Year

  • 2016
    1

Resource Types

  • Dataset
    1

Affiliations

  • Massachusetts General Hospital
    1
  • New York University Langone Medical Center
    1
  • Yale School of Medicine
    1