Evidence map›Paper›PMID 35688481›Full record

ArticleBMJ (Clinical research ed.)2022

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Rebecca J Williams, Heather D Dobbins, Tony Tse, Sandy D Chon, David Loose, Gisele A Sarosy, Sheila A Prindiville, Frank W Rockhold, Deborah A Zarin

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

9 authors.

Rebecca J WilliamsNational Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.ORCID 0000-0002-9906-6864
Heather D DobbinsNational Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.
Tony TseNational Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA atse@mail.nih.gov.
Sandy D ChonEssex Management, Coordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
David LooseEssex Management, Coordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Gisele A SarosyCoordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Sheila A PrindivilleCoordinating Center for Clinical Trials, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Frank W RockholdDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Deborah A ZarinMulti-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA.

Funding

National Biomedical Information ServicesZIHLM200888 · NLM · NATIONAL LIBRARY OF MEDICINE · PI PALTOO, DINA · 2009 to 2025
$5200.7M
6 · The paper itself

Abstract

objectiveTo describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.

designQualitative analysis. DATA SOURCES: ClinicalTrials.gov trial registry.

main outcome measuresEstablished goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified.

resultsA reporting approach is proposed that accommodates the complex study design of MPRPs and their results. This approach involves the use of separate registration records for each substudy within one MPRP protocol (with potential exceptions noted).

conclusionsHow the proposed approach allows for clear, descriptive, structured information about each substudy's prespecified design and supports timely reporting of results after completion of each substudy is described and illustrated. Although the focus is on reporting to ClinicalTrials.gov, the approach supports broader application across trial registries and results databases. This paper is intended to stimulate further discussion of this approach among stakeholders, build awareness about the need to improve reporting of MPRPs, and encourage harmonization across trial registries globally.

Indexed as

Clinical Trials as TopicResearch DesignDatabases, FactualHumansQualitative ResearchRegistries

Identifiers

PMID35688481
PMCPMC9186156

What OpenQuestion holds

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LicenceCC BY-NC
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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.