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Forum on Drug Discovery, Development, and Translation 10 Year Review: 2011-2020 (2021) / Chapter Skim
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Action Collaboratives
Pages 30-33

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From page 30...
... Clinical Trial Site Standards Harmonization35 The cost and duration of clinical trials have escalated dramatically in the past 20 years, hampering the introduction of new therapies; driving recruitment to developing countries; and raising questions about generalizability, data quality, and participant protections. While some sites in the United States are extremely efficient in launching new trials and in identifying participants, many still suffer from Action collaboratives are long delays in contracting and Institutional Review Board approvals, and enrollment ad hoc, participant-driven targets are frequently missed.
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From page 31...
... Converting traditionally anecdotal patient 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 32...
... 39 Broadly defined by the National Center for Chronic Disease Prevention and Health Promotion as "conditions that last 1 year or more and require ongoing medical attention or limit activities of daily living or both." See https://www.cdc.gov/chronicdisease/about/index.htm. 40 See https://www.cdc.gov/chronicdisease/index.htm.
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From page 33...
... Action Collaboratives 33
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Key Terms

  • patient input
  • action collaboratives
  • trial site
  • clinical trial
  • site standards

  • medical product
  • chronic diseases
  • identify gaps
  • clinical trials
  • external thought

  • prevalent chronic
  • thought leaders
  • impede progress
  • activities associated
  • ongoing medical

  • credible evidence
  • prioritize gaps
  • nam perspectives
  • national clinical
  • chronic disease

  • harmonize clinical
  • traditionally anecdotal
  • daily living
  • escalated dramatically
  • trials infrastructure

  • site accreditation
  • product developers
  • chronic conditions
  • anecdotal patient
  • align medical


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