ArticleBMC medical research methodology2025
The REFRACT trial: implementation of Bayesian power priors in a randomised, sequential phase II adaptive platform trial.
Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05848765 (Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms
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11 authors.
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Abstract
backgroundREFRACT is a randomised trial aimed at rapidly evaluating multiple novel therapies against standard treatment for relapsed or refractory follicular lymphoma (rrFL) using a minimal number of patients. To this end, we designed a prospective, adaptive, sequentially randomised clinical trial to allow multiple novel therapies to be assessed sequentially against a control arm of investigator choice standard therapy (ICT).
methodsREFRACT uses a Bayesian power priors approach enabling the sharing of control arm data from previous treatment rounds. The design allows for the randomisation ratio to be changed and fixed to 1:4 in later treatment rounds resulting in fewer patients being recruited to the control arm.
resultsFollowing extensive simulations, we arrived at the selected design of three sequential treatment rounds, each with a control group and a novel experimental arm assessed for the primary outcome of complete metabolic response (CMR) at 24 weeks. Patients in Round 1 are randomised using a 1:1 allocation, with Rounds 2 and 3 randomised using a 1:4 allocation, in favour of experimental treatment. Using Bayesian power priors, data from control patients in earlier rounds will be shared to improve the operating characteristics in the current round. Previous control arm patients will be weighted at 75% of an active control patient within the prior, with opportunities for adjustment should control treatments change over time.
conclusionsWith the use of power priors and an adaptive design this trial will sequentially evaluate three novel treatment regimens in a disease that urgently requires additional treatment options. REFRACT opened to recruitment in July 2023.
trial registrationEudraCT: 2022-000677-75; 10-Feb-2022. CLINICALTRIALS: gov: NCT05848765; 08-May-2023.
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