Evidence map›Paper›PMID 42018561›Full record

ArticlePloS one2026

Understanding how the informed consent process influences the decision to participate in an adaptive platform trial: A scoping review.

Nicole Yada, Luma Samawi, Neill K J Adhikari, Jennifer L Gibson, Robert J Reid, Robert A Fowler

Abstract readScoping Review
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Nicole YadaInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.ORCID https://orcid.org/0000-0001-9409-7613
Luma SamawiInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Neill K J AdhikariInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.ORCID https://orcid.org/0000-0003-4038-5382
Jennifer L GibsonInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Robert J ReidInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Robert A FowlerInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe complex design of adaptive platform trials may be challenging for prospective participants and their families and/or substitute decision makers to understand when approached for informed consent. The purpose of this scoping review is to explore and synthesize literature on how the informed consent process influences the decision to participate in an adaptive platform trial.

methodsA scoping review of empirical literature published in English was conducted using MEDLINE, EMBASE and PsychInfo databases (1976-2025). A key term search strategy examined the overarching concepts of informed consent process and adaptive platform trials. Empirical studies whose participants were adults in a health care delivery or clinical research setting were included. The outcome of interest was factors that affect eligible trial participant decisions to participate in adaptive platform trials. Grey literature was further searched to substantiate and complement the peer reviewed literature.

resultsOf 1085 articles reviewed, four met inclusion criteria. The four papers highlighted challenges in explaining to prospective participants how the randomization ratio may change during the trial and how likely participants are to benefit, as well as the importance of communication outside of the written consent form. Eight grey literature results were included, covering an emerging policy and regulatory discourse, as well as nascent empirical studies examining alternate delivery modalities for consent information.

conclusionsLimited data highlight the importance of empirical investigation into how to facilitate informed participation in adaptive platform trials. More research is needed to understand how this trial design may affect enrollment decisions and therefore associated policies and processes needed to support informed participation in this modernized trial design.

Indexed as

Decision MakingInformed ConsentAdaptive Clinical Trials as TopicHumans

Identifiers

PMID42018561
PMCPMC13102233

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.