ReviewTherapeutic innovation & regulatory science2021
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials.
Review in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Basket and umbrella trials in pediatric precision medicine: a systematic review of designs, opportunities, and challenges.BMC medical research methodology · 2026Pooled it
- Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics.Therapeutic innovation & regulatory science · 2024Pooled it
- Current usage and challenges of master protocols-based on survey results by ASA BIOP oncology methodology working group master protocol sub-team.Annals of translational medicine · 2022Trial
- Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed.Contemporary clinical trials · 2022Trial
- Uncertainty and novel clinical trial designs in oncology - when should equipoise matter?Clinical trials (London, England) · 2026Article
- Advancing clinical trials for rare renal cell carcinoma subtypes: Consensus statements from the International Kidney Cancer Symposium North America 2025 think tank.Urologic oncology · 2026Article
- Progress and challenges in expanding access to clinical trials in pancreatic cancer.Communications medicine · 2026Review
- Mapping outcomes in randomised radiology trials: Protocol for a scoping review.Acta radiologica open · 2026Article
- Article
- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- Randomization in the age of platform trials: unexplored challenges and some potential solutions.BMC medical research methodology · 2025Review
- Glycaemic control in labour with diabetes: GILD, a scoping study.Health technology assessment (Winchester, England) · 2025Article
- Master protocols in low- and middle-income countries: a review of current use, limitations and opportunities for precision medicine.BMJ global health · 2025Review
- An efficient vaccine clinical trial: ACTG A5379 hepatitis B vaccine trial in persons with HIV.Vaccine · 2025Article
- Review
- Antibody treatment of hepatocellular carcinoma: a review of current and emerging approaches.Frontiers in immunology · 2025Review
- Article
- Review
- Molecular and modular intricacies of precision oncology.Frontiers in immunology · 2024Review
- A comparison of Bayesian information borrowing methods in basket trials and a novel proposal of modified exchangeability-nonexchangeability method.Statistics in medicine · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Master protocol, categorized as basket trial, umbrella trial or platform trial, is an innovative clinical trial framework that aims to expedite clinical drug development, enhance trial efficiency, and eventually bring medicines to patients faster. Despite a clear uptake on the advantages in the concepts and designs, master protocols are still yet to be widely used. Part of that may be due to the fact that the master protocol framework comes with the need for new statistical designs and considerations for analyses and operational challenges. In this article, we provide an overview of the master protocol framework, unify the definitions with some examples, review the statistical methods for the designs and analyses, and focus our discussions on some practical considerations and recommendations of master protocols to help practitioners better design and implement such studies.
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What OpenQuestion holds
Registered trials
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.