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Forum on Drug Discovery, Development, and Translation 2019 Annual Report (2020) / Chapter Skim
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Action Collaboratives
Pages 14-17

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From page 14...
... input to rigorous, credible evidence for use by a broad range of stakeholders -- including academic and clinical researchers, medical product developers, patient/ disease advocacy groups, and regulatory decision makers -- could better align medical product development and regulation with patient perspectives on disease experience, burden, management, and treatment. Many efforts have been launched to advance a science of patient input.
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From page 15...
... This work helped inform discussions at a public workshop hosted by the Forum on May 9, 2018, on Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda. Following the workshop, collaborative participants assembled a list of gaps and barriers organized by topic based on points raised by workshop participants.
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From page 16...
... In 2018, the collaborative collected, analyzed, and assessed a set of site standards used by industry sponsors to qualify sites for launching the majority of phase II, III, and IV clinical trials and consolidated them to create a harmonized set of baseline standards, which could be considered for broad application across clinical trial sites by research sponsors. In 2019, a working group of the collaborative produced an internal document that summarized the results of this activity and outlined a set of core harmonized clinical trial site standards.
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From page 17...
... These opportunities and challenges were laid out in the IOM report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, which calls on stakeholders to foster a culture of sharing and offers a blueprint for action within and across sectors. The Forum, along with the National Academies' Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, provided momentum and a framework for initiating the consensus study that produced the report and continue to work together to support coordination and collaboration among stakeholders engaged in data-sharing initiatives through convening and other activities.
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Key Terms

  • collaborative participants
  • patient input
  • clinical trials
  • medical product
  • action collaborative

  • sharing clinical
  • trial site
  • site standards
  • trial data
  • trial sites

  • disease advocacy
  • helped inform
  • nonprofit funders
  • harmonized clinical
  • clinical researchers

  • patient experience
  • incorporate patient
  • lived patient
  • collaborative convened
  • data sharing

  • patient perspectives
  • nonprofit disease
  • participants published
  • global data
  • precision health

  • informal phone
  • support coordination
  • stakeholders engaged
  • advocacy organizations
  • effective development


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