Trial reportBiometrics2023
DROID: dose-ranging approach to optimizing dose in oncology drug development.
Trial report in Biometrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
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Who cites it
16 citing papers in PubMed, 29 citations in OpenAlex.
- Generalized phase I-II designs to increase long term therapeutic success rate.Pharmaceutical statisticsTrial
- Simulation-Calibrated Control of Type I Error Rate in One-Trial Approach with Dose Optimization in Oncology Drug Development.Therapeutic innovation & regulatory science · 2026Article
- Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now?Therapeutic innovation & regulatory science · 2026Article
- Information borrowing in phase II randomized dose-ranging clinical trials in oncology.BMC medical research methodology · 2026Article
- Bayesian model averaging for randomized dose optimization trials in multiple indications.Journal of biopharmaceutical statistics · 2026Article
- Randomized optimal selection design for dose optimization.Biometrics · 2025Article
- BARD: A seamless two-stage dose optimization design integrating backfill and adaptive randomization.Clinical trials (London, England) · 2025Article
- UNITED: A Unified Transparent and Efficient Phase I/II Trial Design for Dose Optimization Accounting for Ordinal Graded, Continuous and Mixed Toxicity and Efficacy Endpoints.Statistics in medicine · 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
- Three steps toward dose optimization for oncology dose finding.Contemporary clinical trials communications · 2024Article
- Review
- Adaptive phase I-II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies.Clinical trials (London, England) · 2024Review
- Statistical and practical considerations in planning and conduct of dose-optimization trials.Clinical trials (London, England) · 2024Review
- A generalized phase 1-2-3 design integrating dose optimization with confirmatory treatment comparison.Biometrics · 2024Article
- Seamless Phase I-II Cancer Clinical Trials Using Kernel-Based Covariate Similarity.Pharmaceutical statisticsArticle
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 1 country.
Funding
Abstract
In the era of targeted therapy, there has been increasing concern about the development of oncology drugs based on the "more is better" paradigm, developed decades ago for chemotherapy. Recently, the US Food and Drug Administration (FDA) initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development. To accommodate this paradigm shifting, we propose a dose-ranging approach to optimizing dose (DROID) for oncology trials with targeted drugs. DROID leverages the well-established dose-ranging study framework, which has been routinely used to develop non-oncology drugs for decades, and bridges it with established oncology dose-finding designs to optimize the dose of oncology drugs. DROID consists of two seamlessly connected stages. In the first stage, patients are sequentially enrolled and adaptively assigned to investigational doses to establish the therapeutic dose range (TDR), defined as the range of doses with acceptable toxicity and efficacy profiles, and the recommended phase 2 dose set (RP2S). In the second stage, patients are randomized to the doses in RP2S to assess the dose-response relationship and identify the optimal dose. The simulation study shows that DROID substantially outperforms the conventional approach, providing a new paradigm to efficiently optimize the dose of targeted oncology drugs. DROID aligns with the approach of a randomized, parallel dose-response trial design recommended by the FDA in the Guidance on Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.
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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.