Evidence map›Paper›PMID 31322732›Full record

ArticleBiometrics2020

A response-adaptive randomization procedure for multi-armed clinical trials with normally distributed outcomes.

S Faye Williamson, Sofía S Villar

Abstract read
In one paragraph

Article in Biometrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Response-adaptive randomization in clinical trials: from myths to practical considerations.Statistical science : a review journal of the Institute of Mathematical Statistics · 2023
    Article
  4. Article
  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

S Faye WilliamsonDepartment of Mathematics and Statistics, Lancaster University, Lancaster, UK.ORCID 0000-0002-1800-6625
Sofía S VillarMRC Biostatistics Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK.ORCID 0000-0001-7755-2637

Funding

Medical Research Council MC_UU_00002/3
6 · The paper itself

Abstract

We propose a novel response-adaptive randomization procedure for multi-armed trials with continuous outcomes that are assumed to be normally distributed. Our proposed rule is non-myopic, and oriented toward a patient benefit objective, yet maintains computational feasibility. We derive our response-adaptive algorithm based on the Gittins index for the multi-armed bandit problem, as a modification of the method first introduced in Villar et al. (Biometrics, 71, pp. 969-978). The resulting procedure can be implemented under the assumption of both known or unknown variance. We illustrate the proposed procedure by simulations in the context of phase II cancer trials. Our results show that, in a multi-armed setting, there are efficiency and patient benefit gains of using a response-adaptive allocation procedure with a continuous endpoint instead of a binary one. These gains persist even if an anticipated low rate of missing data due to deaths, dropouts, or complete responses is imputed online through a procedure first introduced in this paper. Additionally, we discuss how there are response-adaptive designs that outperform the traditional equal randomized design both in terms of efficiency and patient benefit measures in the multi-armed trial context.

Indexed as

AlgorithmsAdaptive Clinical Trials as TopicBiometryClinical Trials, Phase II as TopicComputer SimulationEndpoint DeterminationHumansModels, StatisticalNeoplasmsPatient DropoutsRandomized Controlled Trials as TopicTreatment Outcomeadaptive designscontinuous endpointdichotomizationGittins indexmissing dataunknown variance

Identifiers

PMID31322732
PMCPMC7078926

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.