Evidence map›Paper›PMID 42026863›Full record

ReviewCancer medicine2026

Modern Clinical Trials: Seamless Designs and Master Protocols.

Abigail Burdon, Thomas Jaki, Xijin Chen, Pavel Mozgunov, Haiyan Zheng, Richard Baird

Abstract readReview
In one paragraph

Review in Cancer medicine, 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.

Abigail BurdonMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.ORCID https://orcid.org/0000-0002-0883-4160
Thomas JakiMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
Xijin ChenMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
Pavel MozgunovMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
Haiyan ZhengMRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
Richard BairdDepartment of Oncology, University of Cambridge, Cambridge, UK.

Funding

Cancer Research UK RCCCDF-May24/100001Horizon 2020 Framework Programme 965397Medical Research Council MC_UU_00040/03National Institute for Health and Care Research BRC-1215-20014National Institute for Health and Care Research NIHR300576
6 · The paper itself

Abstract

backgroundDrug development is often inefficient, costly and lengthy, yet it is essential for evaluating the safety and efficacy of new interventions. Compared with other disease areas, this is particularly true for Phase II/III cancer clinical trials where many drug candidates fail to advance and reduced regulatory approvals are being seen. In response to these challenges, seamless clinical trials and master protocols have emerged to streamline the drug development process.

methodsSeamless clinical trials, characterised by their ability to transition seamlessly from one phase to another, can lead to accelerating the development of promising therapies while Master protocols provide a framework for investigating multiple treatment options and patient subgroups within a single trial.

resultsWe discuss the advantages of these methods through real trial examples and the principles that lead to their success while also acknowledging the associated regulatory considerations and challenges.

conclusionSeamless designs and master protocols have the potential to improve confirmatory clinical trials. In the disease area of cancer, this ultimately means that patients can receive life-saving treatments sooner.

Indexed as

Clinical Trials as TopicDrug DevelopmentNeoplasmsResearch DesignAntineoplastic AgentsClinical Trials, Phase II as TopicHumansAntineoplastic Agentsadaptive designsefficient trialsinterim analysismaster protocolsseamless phase II/III

Identifiers

PMID42026863
PMCPMC13106893

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.