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Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers.

Shao-Fan HsiehVictoria Yorke-EdwardsMacey L MurrayCarlos Diaz-MontanaSharon B LoveMatthew Robert Sydes
Published in: Clinical trials (London, England) (2023)
Monitoring information was reported in only approximately half of the protocol papers. Suboptimal reporting of monitoring hinders the clinical community from having the full information on which to judge the validity of a trial and jeopardises the value of protocol papers and the credibility of the trial itself. Greater efforts are needed to promote the transparent reporting of monitoring to journal editors and authors.
Keyphrases
  • study protocol
  • randomized controlled trial
  • phase iii
  • clinical trial
  • phase ii
  • adverse drug
  • healthcare
  • health information
  • open label
  • quality improvement