Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.
Br J Cancer
; 126(2): 204-210, 2022 02.
Article
em En
| MEDLINE
| ID: mdl-34750494
ABSTRACT
BACKGROUND:
Efficient trial designs are required to prioritise promising drugs within Phase II trials. Adaptive designs are examples of such designs, but their efficiency is reduced if there is a delay in assessing patient responses to treatment.METHODS:
Motivated by the WIRE trial in renal cell carcinoma (NCT03741426), we compare three trial approaches to testing multiple treatment arms (1) single-arm trials in sequence with interim analyses; (2) a parallel multi-arm multi-stage trial and (3) the design used in WIRE, which we call the Multi-Arm Sequential Trial with Efficient Recruitment (MASTER) design. The MASTER design recruits patients to one arm at a time, pausing recruitment to an arm when it has recruited the required number for an interim analysis. We conduct a simulation study to compare how long the three different trial designs take to evaluate a number of new treatment arms.RESULTS:
The parallel multi-arm multi-stage and the MASTER design are much more efficient than separate trials. The MASTER design provides extra efficiency when there is endpoint delay, or recruitment is very quick.CONCLUSIONS:
We recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Simulação por Computador
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Ensaios Clínicos Fase II como Assunto
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Ensaios Clínicos Controlados não Aleatórios como Assunto
/
Ensaios Clínicos Adaptados como Assunto
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Oncologia
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Neoplasias
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article