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Value of Data Sharing to Advance Drug Development: A Regulatory Perspective

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Abstract

New tools are needed to evaluate and predict the efficacy and safety of medical products. However, the development of such tools requires collaboration and effective data sharing. In this issue of Therapeutic Innovation & Regulatory Science, scientists from the Critical Path Institute (C-Path) discuss their experiences using patient-level data to facilitate innovation in drug development. We share our perspective on the issues discussed in the C-Path paper and offer suggestions on future efforts.

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References

  1. FDA’s Critical Path Initiative http://wayback.archive-it.org/7993/20180125032208/https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Accessed 24 Sept 2020.

  2. Scientific Public Private Partnerships and Consortia https://www.fda.gov/drugs/science-and-research-drugs/scientific-public-private-partnerships-and-consortia. Accessed 24 Sept 2020.

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  5. Critical Path Institute Data Collaboration Center https://c-path.org/programs/dcc/. Accessed 24 Sept 2020.

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Funding

The authors are Federal Government employees and have received no funding for this paper.

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Authors and Affiliations

  1. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, USA

    Aliza Thompson MD, MS & Ameeta Parekh PhD

Authors
  1. Aliza Thompson MD, MS
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  2. Ameeta Parekh PhD
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The authors have contributed equally towards drafting and revising the content critically for intellectual content.

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Correspondence to Ameeta Parekh PhD.

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The authors have no potential conflicts. COI Forms included.

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Thompson, A., Parekh, A. Value of Data Sharing to Advance Drug Development: A Regulatory Perspective. Ther Innov Regul Sci 55, 850–852 (2021). https://doi.org/10.1007/s43441-021-00275-y

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  • DOI: https://doi.org/10.1007/s43441-021-00275-y

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