Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.
Nina WilsonKatie BiggsSarah BowdenJulia BrownMunyaradzi DimairoLaura FlightJamie HallAnna HockadayThomas JakiRachel LoweCaroline MurphyPhilip PallmannMark A PillingClaire SnowdonMatthew R SydesSofía S VillarChristopher J WeirJessica WelburnChristina YapRebecca MaierHelen HancockJames M S WasonPublished in: BMC medicine (2021)
This work sheds light on additional resources required to adequately support a high-quality adaptive trial. The percentage increase in costs for supporting an adaptive trial was generally modest and should not be a barrier to adaptive designs being cost-effective to use in practice. Informed by the results of this research, guidance for investigators and funders will be developed on appropriately resourcing adaptive trials.