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Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review.

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Area of Science:

  • Clinical trial data sharing
  • Regulatory frameworks
  • Public health research

Background:

  • Clinical trial data sharing is scientifically valuable but remains limited globally.
  • Harmonization efforts are increasing, particularly highlighted by the COVID-19 pandemic.
  • Data exclusivity, funder regulations, and weaker institutional mechanisms in low- and middle-income countries (LMICs) hinder data sharing.

Purpose of the Study:

  • To identify regulatory frameworks and policies governing clinical trial data sharing.
  • To explore key elements of data-sharing mechanisms within existing regulatory documents.
  • To suggest focal areas for policy interventions to facilitate clinical trial data sharing.

Main Methods:

  • A JBI scoping review approach was employed.
  • Searches included electronic databases and gray literature.
  • Included records described clinical trial data-sharing policies, guidelines, or SOPs; findings were synthesized narratively.

Main Results:

  • Four articles and 13 policy documents were identified; none originated from LMICs.
  • Most policies mandated data-sharing agreements (65%), required informed consent (47%), and included review committees (71%).
  • Data-sharing models include controlled- and open-access; incentives and distinctions in consent requirements need clarification.

Conclusions:

  • A pragmatic data-sharing mechanism is urgently needed to enhance research, innovation, and cross-border collaboration.
  • Flexible, comprehensive data-sharing policies should focus on key elements, accommodating regional legislation.
  • Institutional mechanisms should guide data generation, rather than disparate efforts, to support scientific endeavors.