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Forum on Drug Discovery, Development, and Translation 2014 Annual Report (2015) / Chapter Skim
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Reflecting Back: Forum Activities in 2014
Pages 4-5

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From page 4...
... There is increasing attention to the need for enhancing the evaluation and communication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. An extensive body of evidence informs regulatory decisions on the safety and efficacy of a proposed product, but in many cases, FDA must draw conclusions from imperfect data.
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From page 5...
... This action collaborative is an ad hoc convening activity under the auspices of the Forum, which provides a venue for joint and collaborative activities among participants to advance development of standards or a system to improve clinical trial performance through accredita tion of clinical trial sites. Participants, who are drawn from multiple sectors and disciplines, are preparing a Perspective paper, to be posted by the IOM, which will summarize their perspectives on a process for standards development, and on the establishment of a mechanism to facilitate coordination of an experimen tal approach to align existing standards and improve clinical trial site standards based on continuous data collection.
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Key Terms

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  • imperfect data
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  • trial performance
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  • trial sites
  • regulatory decision
  • cal trials

  • key considerations
  • potential analytical
  • research roundtable
  • trials enterprise
  • devote time

  • identified key
  • explored potential
  • existing standards
  • increasing attention
  • dence informs


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