ReviewStatistics in medicine2017
Implementation of adaptive methods in early-phase clinical trials.
Review in Statistics in medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 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
26 citing papers in PubMed.
- Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- Design of a Phase I Drug Combination Study with Adaptive Allocation Based on Dose-Limiting Toxicity Attribution.Cancers · 2025Article
- SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.EClinicalMedicine · 2025Article
- CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.EClinicalMedicine · 2025Article
- Applications of the partial-order continual reassessment method in the early development of treatment combinations.Clinical trials (London, England) · 2024Article
- Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.BMC medicine · 2023Review
- 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
- Experimental Medicine Approaches in Early-Phase CNS Drug Development.Advances in neurobiology · 2023Article
- Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial.Clinical trials (London, England) · 2021Article
- Flexible Phase I-II design for partially ordered regimens with application to therapeutic cancer vaccines.Statistics in biosciences · 2020Article
- Efficient dose-finding for drug combination studies involving a shift in study populations.Contemporary clinical trials communications · 2020Article
- Tailoring early-phase clinical trial design to address multiple research objectives.Cancer immunology, immunotherapy : CII · 2020Article
- Practical considerations for the implementation of adaptive designs for oncology Phase I dose-finding trials.Future drug discovery · 2019Review
- The Impact of Early-Phase Trial Design in the Drug Development Process.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Article
- Revisiting isotonic phase I design in the era of model-assisted dose-finding.Clinical trials (London, England) · 2018Article
- Adaptive designs in clinical trials: why use them, and how to run and report them.BMC medicine · 2018Article
- A web tool for designing and conducting phase I trials using the continual reassessment method.BMC cancer · 2018Article
- Challenges in implementing model-based phase I designs in a grant-funded clinical trials unit.Trials · 2017Article
- Implementation of a Model-Based Design in a Phase Ib Study of Combined Targeted Agents.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
There has been constant development of novel statistical methods in the design of early-phase clinical trials since the introduction of model-based designs, yet the traditional or modified 3+3 algorithmic design remains the most widely used approach in dose-finding studies. Research has shown the limitations of this traditional design compared with more innovative approaches yet the use of these model-based designs remains infrequent. This can be attributed to several causes including a poor understanding from clinicians and reviewers into how the designs work, and how best to evaluate the appropriateness of a proposed design. These barriers are likely to be enhanced in the coming years as the recent paradigm of drug development involves a shift to more complex dose-finding problems. This article reviews relevant information that should be included in clinical trial protocols to aid in the acceptance and approval of novel methods. We provide practical guidance for implementing these efficient designs with the aim of augmenting a broader transition from algorithmic to adaptive model-guided designs. In addition we highlight issues to consider in the actual implementation of a trial once approval is obtained. Copyright © 2016 John Wiley & Sons, Ltd.
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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.