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Analysis Strengthening Research for Health in the Americas

Clinical trial transparency in the Americas: the need to coordinate regulatory spheres

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k2493 (Published 16 July 2018) Cite this as: BMJ 2018;362:k2493

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  1. Trudo Lemmens, professor and Scholl chair in health law and policy1,
  2. Carlos Herrera Vacaflor, researcher 2
  1. 1Faculty of law and Dalla Lana School of Public Health, University of Toronto, Canada
  2. 2Faculty of law, University of Toronto, Canada
  3. Correspondence to: T Lemmens Trudo.Lemmens@utoronto.ca

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

In its 2009 Policy on Research for Health, the Pan American Health Organization/World Health Organization (PAHO/WHO) reiterated the key role of transparency in ensuring reliable research for health.1 In the wake of several high profile controversies, transparency has been particularly promoted in the context of industry sponsored pharmaceutical trials aimed at producing data for drug regulatory approval.2 In response to these controversies, various stakeholders have pushed for clinical trial registration and access to data submitted to drug regulatory agencies as key transparency tools, to enhance evidence informed decision making by clinicians, regulators, and society.2

Notwithstanding widespread support for transparency, its implementation faces significant challenges. Transparency of pharmaceutical data has been hampered by the qualification of such data as commercially confidential information and by inconsistencies in overlapping regulatory spheres. This article will first discuss key developments related to registering pharmaceutical clinical trials and sharing data submitted to drug regulatory agencies in the Americas. Then, reports …

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