Evidence map›Paper›PMID 34750494›Full record

ArticleBritish journal of cancer2022

Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.

Helen Mossop, Michael J Grayling, Ferdia A Gallagher, Sarah J Welsh, Grant D Stewart, James M S Wason

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in British journal of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03741426 (WIndow of Opportunity Clinical Trials Platform for Evaluation of Novel Treatments Strategies in REnal Cell Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 26% of its field
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.

NCT03741426 phase2unknown statusnot on this map

WIndow of Opportunity Clinical Trials Platform for Evaluation of Novel Treatments Strategies in REnal Cell Cancer

TypeinterventionalSponsorCCTU- Cancer ThemeRan2020 to 2025Enrolled60ConditionsRenal Cell CancerArmsOlaparib, Cediranib, Durvalumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
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

6 authors at 2 institutions in 1 country.

Helen Mossop *Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
Michael J Grayling *Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-0680-6668
Ferdia A GallagherDepartment of Radiology, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0003-4784-5230
Sarah J WelshDepartment of Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.ORCID http://orcid.org/0000-0001-5690-2677
Grant D StewartDepartment of Surgery, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK.ORCID http://orcid.org/0000-0003-3188-9140
James M S WasonPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK. james.wason@newcastle.ac.uk.ORCID http://orcid.org/0000-0002-4691-126X
Newcastle University · GBUniversity of Cambridge · GB

Funding

Cancer Research UK 16628Cancer Research UK 27150Medical Research Council MC_UU_00002/6Medical Research Council MR/T024097/1
6 · The paper itself

Abstract

backgroundEfficient 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.

methodsMotivated 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.

resultsThe 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.

conclusionsWe recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials.

Indexed as

Adaptive Clinical Trials as TopicClinical Trials, Phase II as TopicCohort StudiesComputer SimulationHumansMedical OncologyNeoplasmsNon-Randomized Controlled Trials as TopicResearch DesignSample SizeTreatment Outcome

Identifiers

PMID34750494
PMCPMC8770479
OpenAlexW3212840814

What OpenQuestion holds

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Registered trials

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.