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Effective Data Sharing as a Conduit for Advancing Medical Product Development.

Stephen R Karpen1, J Kael White1, Ariana P Mullin1

  • 1Critical Path Institute, 1730 E. River Rd. Ste 200, Tucson, AZ, 85718, USA.

Therapeutic Innovation & Regulatory Science
|January 5, 2021
PubMed
Summary

Patient-level data sharing optimizes medical product development by enabling actionable insights and decision-making. Successful initiatives require broad stakeholder partnerships and a neutral convenor for pre-competitive collaboration.

Keywords:
DataData-sharingDrug development toolsProduct developmentPublic–private partnershipsRegulatory science

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Area of Science:

  • Biomedical research
  • Drug development
  • Regulatory science

Background:

  • Patient-level data sharing can significantly improve medical product development.
  • Successful data sharing is defined as actionable data that aids decision-making during product development and review.

Purpose of the Study:

  • To explore the impact and definition of successful patient-level data sharing in medical product development.
  • To identify challenges and solutions for regulatory data sharing initiatives.
  • To present examples of successful data sharing.

Main Methods:

  • Establishing extensive partnerships among industry, academia, research institutes, patient-advocacy groups, and governmental agencies.
  • Utilizing a neutral third-party organization to provide a pre-competitive space for data sharing.
  • Analyzing regulatory data sharing challenges and solutions.

Main Results:

  • Successful data sharing leads to new development tools and methodologies (e.g., novel clinical trial designs, predictive models, biomarkers).
  • Regulatory data sharing faces unique challenges compared to clinical decision-making data sharing.
  • Commitment from all stakeholders is crucial for successful regulatory data sharing.

Conclusions:

  • Patient-level data sharing is vital for optimizing the medical product development process.
  • Collaborative partnerships and neutral convenors are essential for effective data sharing.
  • Addressing regulatory data sharing challenges is key to realizing its full potential.