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Clinical trial registration and reporting: a survey of academic organizations in the United States.

Evan Mayo-WilsonJames HeywardAnthony KeyesJesse ReynoldsSarah WhiteNidhi AtriG Caleb AlexanderAudrey OmarDaniel E Fordnull null
Published in: BMC medicine (2018)
Before the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.
Keyphrases
  • clinical trial
  • adverse drug
  • phase ii
  • public health
  • study protocol
  • phase iii
  • open label
  • randomized controlled trial