Evidence map›Paper›PMID 26993469›Full record

ReviewTrials2016

Adaptive designs undertaken in clinical research: a review of registered clinical trials.

Isabella Hatfield, Annabel Allison, Laura Flight, Steven A Julious, Munyaradzi Dimairo

Abstract readReview
In one paragraph

Review in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 2 pooled it
–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

50 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Article
  5. A Pragmatic Bayesian Adaptive Trial Design Based on the Value of Information: The Value-Driven Adaptive Design.Medical decision making : an international journal of the Society for Medical Decision Making · 2026
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Expected Value of Sample Information to Guide the Design of Group Sequential Clinical Trials.Medical decision making : an international journal of the Society for Medical Decision Making · 2022
    Article
  20. 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

5 authors.

Isabella HatfieldSchool of Mathematics & Statistics, Newcastle University, Herschel Building, Newcastle upon Tyne, NE1 7RU, UK.
Annabel AllisonScHARR, University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK.
Laura FlightScHARR, University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK.
Steven A JuliousScHARR, University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK.
Munyaradzi DimairoScHARR, University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK. m.dimairo@sheffield.ac.uk.

Funding

Department of Health DRF-2012-05-182
6 · The paper itself

Abstract

Adaptive designs have the potential to improve efficiency in the evaluation of new medical treatments in comparison to traditional fixed sample size designs. However, they are still not widely used in practice in clinical research. Little research has been conducted to investigate what adaptive designs are being undertaken. This review highlights the current state of registered adaptive designs and their characteristics. The review looked at phase II, II/III and III trials registered on ClinicalTrials.gov from 29 February 2000 to 1 June 2014, supplemented with trials from the National Institute for Health Research register and known adaptive trials. A range of adaptive design search terms were applied to the trials extracted from each database. Characteristics of the adaptive designs were then recorded including funder, therapeutic area and type of adaptation. The results in the paper suggest that the use of adaptive designs has increased. They seem to be most often used in phase II trials and in oncology. In phase III trials, the most popular form of adaptation is the group sequential design. The review failed to capture all trials with adaptive designs, which suggests that the reporting of adaptive designs, such as in clinical trials registers, needs much improving. We recommend that clinical trial registers should contain sections dedicated to the type and scope of the adaptation and that the term 'adaptive design' should be included in the trial title or at least in the brief summary or design sections.

Indexed as

RegistriesResearch DesignClinical Trials as TopicData CollectionHumansQuality ControlTerminology as TopicAdaptive designClinical trialFlexible design

Identifiers

PMID26993469
PMCPMC4799596

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.