ArticleClinical cancer research : an official journal of the American Association for Cancer Research2019
The Impact of Early-Phase Trial Design in the Drug Development Process.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
What it found
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Who cites it
33 citing papers in PubMed.
- Distributed Pharmacodynamic Architecture in Multi-Component Herbal Formulations: A Flux-Based Framework for Redox-Heterogeneous Diseases.Pharmaceutics · 2026Review
- A Novel Method for Inserting Dose Levels Mid-Trial in Early-Phase Oncology Combination Studies.Statistics in medicine · 2026Article
- Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward.Drugs & aging · 2025Review
- Dose-finding designs for cell therapy cancer clinical trials evaluating drug-combinations.Contemporary clinical trials · 2025Article
- Design of a Phase I Drug Combination Study with Adaptive Allocation Based on Dose-Limiting Toxicity Attribution.Cancers · 2025Article
- Understanding the Role of Patient-Reported Outcomes for Decision-Making in Early-Phase Dose-Finding Clinical Trials.Current oncology (Toronto, Ont.) · 2025Article
- Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes.Statistics in biopharmaceutical research · 2025Article
- Tips for Accelerating BOIN Design.Therapeutic innovation & regulatory science · 2024Article
- Dose-finding based on feasibility and late-onset toxicity in adoptive cell therapy trials.Journal of biopharmaceutical statistics · 2024Article
- A comparison of model-free phase I dose escalation designs for dual-agent combination therapies.Statistical methods in medical research · 2024Article
- Early phase clinical trials in oncology: Realising the potential of seamless designs.European journal of cancer (Oxford, England : 1990) · 2023Article
- Looking ahead in early-phase trial design to improve the drug development process: examples in oncology.BMC medical research methodology · 2023Article
- Application of the patient-reported outcomes continual reassessment method to a phase I study of radiotherapy in endometrial cancer.The international journal of biostatistics · 2023Article
- Concurrent dose-finding of a novel cancer drug with and without a second agent.Journal of clinical and translational science · 2023Article
- Practical implementation of the partial ordering continual reassessment method in a Phase I combination-schedule dose-finding trial.Statistics in medicine · 2022Article
- Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models.CPT: pharmacometrics & systems pharmacology · 2022Article
- Extending the Continual Reassessment Method to accommodate step-up dosing in Phase I trials.Statistics in medicine · 2022Article
- An overview of the BOIN design and its current extensions for novel early-phase oncology trials.Contemporary clinical trials communications · 2022Review
- Adaptive Phase 1 Design in Radiation Therapy Trials.International journal of radiation oncology, biology, physics · 2022Article
- Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial.Contemporary clinical trials communications · 2022Article
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Abstract
purposeMany of the therapeutic agents that are being used currently were developed using the 3+3 decision rule for dose finding. Over the past 30 years, several dose-finding designs have been proposed and evaluated, including the "continual reassessment method" (CRM) and the "Bayesian optimal interval design" (BOIN). This research investigates the role of the choice of an early-phase design on the likelihood that drugs entering the drug development pipeline will have 2 successful phase III trials.
resultsThe results indicate that using the CRM or BOIN, rather than the 3+3, substantially enhances the proportion of effective agents that have successful phase III trials, with the CRM having a greater effect than BOIN. A larger phase II trial magnifies the effect of the phase I design.
conclusionsThe results underscore the importance of the choice of the early-phase designs. Use of the 3+3 results in fewer agents with successful phase III trials compared with the CRM or BOIN. The difference is more pronounced among highly effective agents. In addition, the results show the importance of a sufficiently powered phase II trial.
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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.