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Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review.

Nachiket GudiPrashanthi KamathTrishnika ChakrabortyAnil G JacobShradha S ParsekarSuptendra Nath SarbadhikariOommen John
Published in: Journal of medical Internet research (2022)
Our review outlines the immediate need for developing a pragmatic data-sharing mechanism that aims to improve research and innovations as well as facilitate cross-border collaborations. Although a one-policy-fits-all approach would not account for regional and subnational legislation, we suggest that a focus on key elements of data-sharing mechanisms can be used to inform the development of flexible yet comprehensive data-sharing policies so that institutional mechanisms rather than disparate efforts guide data generation, which is the foundation of all scientific endeavor.
Keyphrases
  • electronic health record
  • clinical trial
  • big data
  • social media
  • public health
  • health information
  • healthcare
  • randomized controlled trial
  • mental health
  • open label
  • deep learning
  • phase iii
  • double blind