Litcius/Paper detail

Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements

Reshma Ramachandran, Christopher J. Morten, Joseph S. Ross

2021JAMA20 citationsDOI

Abstract

This Viewpoint discusses ways in which the FDA could harness its enforcement tools to bring important missing clinical trial results information to light and demonstrate its commitment to protecting patients through clinical trial transparency.

Topics & Concepts

MedicineEnforcementTransparency (behavior)Clinical trialClinical researchInternet privacyComputer securityPathologyLawPolitical scienceComputer scienceBiomedical Ethics and RegulationHealth and Medical Research ImpactsEthics in Clinical Research