Evidence map›Paper›PMID 40713083›Full record

ReviewBMJ global health2025

Master protocols in low- and middle-income countries: a review of current use, limitations and opportunities for precision medicine.

Luke O Ouma, Sarah Al-Ashmori, Samuel Sarkodie, Lou Whitehead, Ann Breeze Konkoth, Shaun Hiu, Theophile Bigirumurame, Dorcas Njeri Kareithi, Jingky Lozano-Kuehne, Marzieh Shahmandi and 1 more

Abstract readReview
In one paragraph

Review in BMJ global health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Luke O OumaBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK ouma.ondijo@gmail.com.ORCID http://orcid.org/0000-0001-9145-8719
Sarah Al-AshmoriBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Samuel SarkodieBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Lou WhiteheadBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Ann Breeze KonkothBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Shaun HiuBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Theophile BigirumurameBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Dorcas Njeri KareithiBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-2161-8542
Jingky Lozano-KuehneBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
Marzieh ShahmandiBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.
James M S WasonBiostatistics research group, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaster protocols-umbrella, basket and platform trials, study multiple therapies, multiple diseases or both, offering many advantages, most profoundly that they answer multiple treatment-related questions, which would otherwise take multiple trials. We conducted a review of clinical trial registries to characterise their use in advancing precision medicine in low and middle-income countries (LMICs).

methodsWe searched trial records available in 20 trial registries globally, including ClinicalTrials.gov and WHO ICTRP, to identify umbrella, basket and platform trials launched until 30 September 2023.

resultsWe identified 102 master protocols-29 umbrella trials, 31 basket trials, 36 platform trials, as well as six other designs that partially aligned with the working definition of master protocols, run in 54 different LMICs. Most trials were pharmaceutical industry-sponsored studies (60/102, 58.8%), conducted in oncology settings (56/102, 54.9%), currently ongoing (69/102, 67.6%) in early phase (phase I and II) settings (70/102, 68.6%) and have been planned or launched in the last 5 years (93/102, 91.2%), mainly with international collaborations in high-income countries. China was a site to more than half of all master protocols (53/102, 52%), and only a small proportion of trials (5/102, 4.9%) launched exclusively in LMICs excluding China and European middle-income countries. For most studies, aspects of trial design and trial documentation (including study protocols and analysis plans) were not publicly accessible.

conclusionUnlike high-income countries, where several hundreds of master protocols are ongoing or completed, there is limited use of master protocols in LMICs, partly owing to low penetration of precision medicine research and limited clinical trial infrastructure in most LMICs. The evidence presented here creates a case for supporting precision medicine initiatives in LMICs (especially Africa) and training and capacity building initiatives focused on innovative clinical trial designs like master protocols, especially in therapeutic areas outside oncology.

Indexed as

Clinical ProtocolsClinical Trials as TopicDeveloping CountriesPrecision MedicineResearch DesignHumansRegistriesClinical trialGlobal HealthRandomised control trialReview

Identifiers

PMID40713083
PMCPMC12306224

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.