The importance of planning for a seamless transition in an adaptive phase II randomised trial
نویسندگان
چکیده
Methods NEO-ESCAPE was a randomised two arm phase II study in inoperable ovarian cancer designed as an external pilot to inform a future phase III randomised controlled trial. The primary objective was to assess the feasibility of two new extended chemotherapy regimens with 44 patients required on each arm. If one or both treatment arms proved feasible, the trial would continue to recruit to the feasible treatment arm(s) to improve the estimates of outcomes to be used in the phase III trial. Stopping rules were essential to enable pre-planned decisions on the futility of continuing to the required 44 patients on each arm. Simulations to assess futility were used in the decision making process.
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