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January 5, 2016PLoS Medicine210 citationsOpen Access

Developing Global Norms for Sharing Data and Results during Public Health Emergencies

KMKayvon ModjarradVMVasee MoorthyPMPiers Millett

Key Points

  • The aim is to establish global norms for sharing clinical trial data during public health emergencies.
  • Review of WHO mandates and data sharing practices
  • Analysis of the impact of recent WHO positions on data disclosure
  • Recommendations for implementation by stakeholders
  • WHO advocates for key outcomes of all interventional trials to be shared within 12 months of completion
  • Increased acceptance of open-access norms among sponsors, investigators, and journals
  • Calls for action from the global health community to adhere to these standards

Abstract

Among the core functions of the World Health Organization (WHO) are to provide "leadership on matters critical to health" and to shape "the research agenda and stimulate the generation, translation, and dissemination of valuable knowledge" in the interest of global public health These mandates have converged, of late, in the area of data sharing. In April 2015, the WHO adopted a position on the timely, public disclosure of clinical trial results 2, adding to other calls that nondisclosure of research data must no longer be tolerated. The global norm advocated by the WHO is to release key outcomes of all interventional clinical trials in an open-access, searchable database within 12 months of primary completion. The WHO has since called on sponsors, investigators, journals, and other bodies to do all in their power to implement this standard. Even as this position is becoming widely accepted, it has become

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Cite This Study

Modjarrad et al. (2016) studied this question.

synapsesocial.com/papers/6a100625b6f5ee0401603478https://doi.org/10.1371/journal.pmed.1001935
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