UofT Law faculty authors: 

Trudo Lemmens & Carlos Herrera Vacaflor, "Clinical Trials Transparency in the Americas: The Need to Coordinate Regulatory Spheres" (2018) 362 British Medical Journal k2493


Numerous initiatives have contributed to health data transparency in the Americas, but further coordinated effort is needed to ensure the reliability of research for health, argue Trudo Lemmens and Carlos Herrera Vacaflor

Key messages

  • •National health regulatory agencies involved in health related research governance should harmonise and streamline both research ethics committee governance and transparency requirements in different regulatory regimes

  • •Drug regulatory agencies in Pan American Health Organization member states should follow the approach taken by the European Medicines Agency with respect to clinical data used for a regulatory decision—that the data do not constitute commercially confidential information and that the burden of proof is on drug companies to argue why specific data should be kept confidential

  • •Research ethics committees can play a coordinating role in the promotion of transparency standards to the extent that the governance structure of committees reflects their public interest nature

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