Compliance with legal requirement to report clinical trial results on a cohort study

  title={Compliance with legal requirement to report clinical trial results on a cohort study},
  author={N. DeVito and S. Bacon and B. Goldacre},
  journal={The Lancet},
  • N. DeVito, S. Bacon, B. Goldacre
  • Published 2020
  • Medicine
  • The Lancet
  • BACKGROUND Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto within 1 year of completion. The first trials covered by the Final Rule of this act became due to report… CONTINUE READING
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    Compliance with results reporting at
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