Evidence map›Paper›PMID 31334382›Full record

ArticleContemporary clinical trials communications2019

Reporting of master protocols towards a standardized approach: A systematic review.

Ellie G Siden, Jay Jh Park, Michael J Zoratti, Louis Dron, Ofir Harari, Kristian Thorlund, Edward J Mills

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 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

19 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  7. Review
  8. Article
  9. The Role of Master Protocols in Pediatric Drug Development.Therapeutic innovation & regulatory science · 2022
    Review
  10. Bayesian modelling strategies for borrowing of information in randomised basket trials.Journal of the Royal Statistical Society. Series C, Applied statistics · 2022
    Article
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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.

Ellie G SidenMTEK Sciences, 777 West Broadway, Suite 802, Vancouver, BC, V5Z 1J5, Canada.
Jay Jh ParkMTEK Sciences, 777 West Broadway, Suite 802, Vancouver, BC, V5Z 1J5, Canada.
Michael J ZorattiDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, 1280 Main St, 2C Area, Hamilton, ON, L8S 4K1, Canada.
Louis DronMTEK Sciences, 777 West Broadway, Suite 802, Vancouver, BC, V5Z 1J5, Canada.
Ofir HarariMTEK Sciences, 777 West Broadway, Suite 802, Vancouver, BC, V5Z 1J5, Canada.
Kristian ThorlundMTEK Sciences, 777 West Broadway, Suite 802, Vancouver, BC, V5Z 1J5, Canada.
Edward J MillsMTEK Sciences, 777 West Broadway, Suite 802, Vancouver, BC, V5Z 1J5, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. Master protocols refer to a single overarching protocol developed to evaluate multiple hypotheses and may be further categorized as basket, umbrella, and platform trials. However, inconsistencies in reporting persist in the literature. We conducted a systematic review to describe master protocol reporting with the goal of facilitating the further development and spread of these innovative trial designs.

methodsWe searched MEDLINE, EMBASE, and CENTRAL from inception to April 25, 2019 for English articles on master protocols. This was supplemented by hand searches of trial registries and of the bibliographies of published reviews. We used the FDA's definitions of master protocols as references and compared them to self-reported master protocols.

resultsWe identified 278 master protocol publications, consisting of 228 protocols and 50 reviews. Sixty-six records provided unique definitions of master protocol types. We observed considerable heterogeneity in definitions of master protocols, and over half (54%) used oncology-specific language. The majority of self-classified master protocols (57%) were consistent with the FDA's definitions of master protocols.

conclusionThe terms 'master protocol', 'basket trial', 'umbrella trial', and 'platform trial' are inconsistently described. Careful treatment of these terms and adherence to the definitions set forth by the FDA will facilitate better understanding of these trial designs and allow them to be used broadly and to their full potential in clinical research. We encourage trial methodologists to use these trial designations when applicable.

Indexed as

Basket trialsMaster protocolsNomenclaturePlatform trialsUmbrella trials

Identifiers

PMID31334382
PMCPMC6616543

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.