Evidence map›Paper›PMID 37736079›Full record

ArticleBMJ medicine2023

Transparent reporting of adaptive clinical trials using concurrently randomised cohorts.

Ian C Marschner, Mark Jones, James A Totterdell, Robert K Mahar, Thomas L Snelling, Steven Y C Tong, Australasian Covid-19 Trial (ASCOT) study group

Abstract read
In one paragraph

Article in BMJ medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
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

7 authors.

Ian C MarschnerNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0002-6225-1572
Mark JonesSchool of Public Health, University of Sydney, Sydney, NSW, Australia.
James A TotterdellSchool of Public Health, University of Sydney, Sydney, NSW, Australia.
Robert K MaharMelbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.
Thomas L SnellingSchool of Public Health, University of Sydney, Sydney, NSW, Australia.
Steven Y C TongDepartment of Infectious Diseases, University of Melbourne, Melbourne, VIC, Australia.ORCID 0000-0002-1368-8356
Australasian Covid-19 Trial (ASCOT) study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adaptive clinical trials have designs that evolve over time because of changes to treatments or changes to the chance that participants will receive these treatments. These changes might introduce confounding that biases crude comparisons of the treatment arms and makes the results from standard reporting methods difficult to interpret for adaptive trials. To deal with this shortcoming, a reporting framework for adaptive trials was developed based on concurrently randomised cohort reporting. A concurrently randomised cohort is a subgroup of participants who all had the same treatments available and the same chance of receiving these treatments. The reporting of pre-randomisation characteristics and post-randomisation outcomes for each concurrently randomised cohort in the study is recommended. This approach provides a transparent and unbiased display of the degree of baseline balance and the randomised treatment comparisons for adaptive trials. The key concepts, terminology, and recommendations underlying concurrently randomised cohort reporting are presented, and its routine use in adaptive trial reporting is advocated.

Indexed as

clinical trialresearch designstatistics

Identifiers

PMID37736079
PMCPMC10510920

What OpenQuestion holds

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Registered trials

None linked

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.