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Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.

Christina YapJan RekowskiMoreno UrsinoOlga SolovyevaDhrusti PatelMunyaradzi DimairoChristopher J WeirAn-Wen ChanThomas F JakiAdrian P ManderThomas R Jeffry EvansRichard Wilson PeckKathryn S HaywardMelanie Jane CalvertKhadija Rerhou RantellShing LeeAndrew KightleySally HopewellDeborah AshbyElizabeth Garrett-MayerJohn Dudley IsaacsRobert GolubOlga KholmanskikhDawn P RichardsOliver BoixJames MatchamLesley SeymourSusan Percy IvyLynley V MarshallAntoine HommaisRong LiuYoshiya TanakaJordan D BerlinAude EspinasseJohann S de Bono
Published in: BMJ (Clinical research ed.) (2023)
Keyphrases
  • clinical trial
  • phase ii
  • study protocol
  • randomized controlled trial
  • quality improvement
  • double blind
  • phase iii