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'We all want to succeed, but we've also got to be realistic about what is happening': an ethnographic study of relationships in trial oversight and their impact.

Anne DaykinLucy Ellen SelmanHelen CramerSharon McCannGillian W ShorterMatthew R SydesCarrol GambleRhiannon MacefieldJ Athene LaneAlison Shaw
Published in: Trials (2017)
Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines.
Keyphrases
  • phase iii
  • study protocol
  • phase ii
  • clinical trial
  • healthcare
  • randomized controlled trial
  • clinical practice
  • open label
  • placebo controlled