ReviewClinical trials (London, England)2024
Statistical and practical considerations in planning and conduct of dose-optimization trials.
Review in Clinical trials (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- From Phase Ib/II to Seamless Phase II/III: A Simulation-Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase.Clinical pharmacology and therapeutics · 2026Article
- A review of seamless phase I/II trial designs towards oncology dose optimization with examples of clinical pharmacology considerations in early drug development.European journal of clinical pharmacology · 2026Review
- BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity.Therapeutic innovation & regulatory science · 2026Article
- Generalized Pairwise Comparisons in Dose Optimization Oncology Trials: Beyond Safety to Multi-outcome Dose Selection.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Utility-Based Dose Selection for Stereotactic Body Radiation Therapy in Hepatocellular Carcinoma.International journal of radiation oncology, biology, physics · 2026Article
- Information borrowing in phase II randomized dose-ranging clinical trials in oncology.BMC medical research methodology · 2026Article
- A Novel Method for Inserting Dose Levels Mid-Trial in Early-Phase Oncology Combination Studies.Statistics in medicine · 2026Article
- A robust Bayesian dose optimization design with backfill and randomization for phase I/II clinical trials.Statistical methods in medical research · 2025Article
- BARD: A seamless two-stage dose optimization design integrating backfill and adaptive randomization.Clinical trials (London, England) · 2025Article
- Practical Considerations for Using the TITE-BOIN Design to Handle Late-Onset Toxicity or Fast Accrual in Phase I Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- Posterior Predictive Design for Phase I Clinical Trials.Journal of the American Statistical Association · 2025Article
- COMIC: A Bayesian Dose Optimization Design for Drug Combination in Multiple Indications With Application to CAR-T Therapies.Statistics in medicine · 2025Article
- ROMI: a randomized two-stage basket trial design to optimize doses for multiple indications.Biometrics · 2024Article
- Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The U.S. Food and Drug Administration launched Project Optimus with the aim of shifting the paradigm of dose-finding and selection toward identifying the optimal biological dose that offers the best balance between benefit and risk, rather than the maximum tolerated dose. However, achieving dose optimization is a challenging task that involves a variety of factors and is considerably more complicated than identifying the maximum tolerated dose, both in terms of design and implementation. This article provides a comprehensive review of various design strategies for dose-optimization trials, including phase 1/2 and 2/3 designs, and highlights their respective advantages and disadvantages. In addition, practical considerations for selecting an appropriate design and planning and executing the trial are discussed. The article also presents freely available software tools that can be utilized for designing and implementing dose-optimization trials. The approaches and their implementation are illustrated through real-world examples.
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Registered trials
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