ReviewClinical pharmacology and therapeutics2021
Collaborative Platform Trials to Fight COVID-19: Methodological and Regulatory Considerations for a Better Societal Outcome.
Review in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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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
17 citing papers in PubMed, 35 citations in OpenAlex.
- Trial
- Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed.Contemporary clinical trials · 2022Trial
- Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial.The Lancet. Respiratory medicine · 2021Trial
- On the Inclusion of Non-Concurrent Controls in Platform Trials With an Interim Analysis.Statistics in medicine · 2026Article
- Randomization in the age of platform trials: unexplored challenges and some potential solutions.BMC medical research methodology · 2025Review
- Operating characteristics of unequal allocation ratios in platform trials with the staggered addition of drugs using binary endpoints.Contemporary clinical trials communications · 2025Article
- Why and how should we simulate platform trials? Learnings from EU-PEARL.BMC medical research methodology · 2025Article
- Innovative approaches for vaccine trials as a key component of pandemic preparedness - a white paper.Infection · 2024Review
- Online error rate control for platform trials.Statistics in medicine · 2023Article
- Estimands and Complex Innovative Designs.Clinical pharmacology and therapeutics · 2022Review
- Novel Strategies for the Treatment of COVID-19.Drugs in R&D · 2022Article
- Therapeutic strategies to address monkeypox.Expert review of anti-infective therapy · 2022Article
- On model-based time trend adjustments in platform trials with non-concurrent controls.BMC medical research methodology · 2022Article
- Clinical Evidence Informing Treatment Guidelines on Repurposed Drugs for Hospitalized Patients During the Early COVID-19 Pandemic: Corticosteroids, Anticoagulants, (Hydroxy)chloroquine.Frontiers in public health · 2022Review
- Selection bias, investment decisions and treatment effect distributions.Pharmaceutical statistics · 2021Article
- Article
- Design Considerations for a Phase II Platform Trial in Major Depressive Disorder.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For the development of coronavirus disease 2019 (COVID-19) drugs during the ongoing pandemic, speed is of essence whereas quality of evidence is of paramount importance. Although thousands of COVID-19 trials were rapidly started, many are unlikely to provide robust statistical evidence and meet regulatory standards (e.g., because of lack of randomization or insufficient power). This has led to an inefficient use of time and resources. With more coordination, the sheer number of patients in these trials might have generated convincing data for several investigational treatments. Collaborative platform trials, comparing several drugs to a shared control arm, are an attractive solution. Those trials can utilize a variety of adaptive design features in order to accelerate the finding of life-saving treatments. In this paper, we discuss several possible designs, illustrate them via simulations, and also discuss challenges, such as the heterogeneity of the target population, time-varying standard of care, and the potentially high number of false hypothesis rejections in phase II and phase III trials. We provide corresponding regulatory perspectives on approval and reimbursement, and note that the optimal design of a platform trial will differ with our societal objective and by stakeholder. Hasty approvals may delay the development of better alternatives, whereas searching relentlessly for the single most efficacious treatment may indirectly diminish the number of lives saved as time is lost. We point out the need for incentivizing developers to participate in collaborative evidence-generation initiatives when a positive return on investment is not met.
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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.