ArticleStatistics in medicine2009
Using short-term response information to facilitate adaptive randomization for survival clinical trials.
Article in Statistics in medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review.Journal of biopharmaceutical statistics · 2016Pooled it
- A Biomarker Signature-Guided Clinical Trial Design for Precision Medicine.Statistics in medicine · 2025Article
- The Win Ratio Approach in Bayesian Monitoring for Two-Arm Phase II Clinical Trial Designs With Multiple Time-To-Event Endpoints.Statistics in medicine · 2024Article
- A Bayesian adaptive biomarker stratified phase II randomized clinical trial design for radiotherapies with competing risk survival outcomes.Statistical methods in medical research · 2024Article
- Bayesian adaptive design for covariate-adaptive historical control information borrowing.Statistics in medicine · 2023Article
- Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol.Therapeutic innovation & regulatory science · 2023Review
- A Bayesian hierarchical monitoring design for phase II cancer clinical trials: Incorporating information on response duration into monitoring rules.Statistics in medicine · 2021Article
- Response adaptive randomization procedures in seamless phase II/III clinical trials.Journal of biopharmaceutical statistics · 2020Article
- Bayesian selective response-adaptive design using the historical control.Statistics in medicine · 2018Article
- A surrogate-primary replacement algorithm for response-adaptive randomization in stroke clinical trials.Statistical methods in medical research · 2017Article
- A novel evaluation of optimality for randomized controlled trials.Journal of biopharmaceutical statistics · 2017Article
- Clinical trial designs incorporating predictive biomarkers.Cancer treatment reviews · 2016Review
- Adaptive clinical trial designs in oncology.Chinese clinical oncology · 2014Article
- Outcome-adaptive randomization for a delayed outcome with a short-term predictor: imputation-based designs.Statistics in medicine · 2014Article
- Evaluating many treatments and biomarkers in oncology: a new design.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013Article
- Adaptive adjustment of the randomization ratio using historical control data.Clinical trials (London, England) · 2013Article
- Sequential design of phase II-III cancer trials.Statistics in medicine · 2012Article
- Innovative Clinical Trial Designs: Toward a 21st-Century Health Care System.Statistics in biosciences · 2011Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
Increased survival is a common goal of cancer clinical trials. Owing to the long periods of observation and follow-up to assess patient survival outcome, it is difficult to use outcome-adaptive randomization in these trials. In practice, often information about a short-term response is quickly available during or shortly after treatment, and this short-term response is a good predictor for long-term survival. For example, complete remission of leukemia can be achieved and measured after a few cycles of treatment. It is a short-term response that is desirable for prolonging survival. We propose a new design for survival trials when such short-term response information is available. We use the short-term information to 'speed up' the adaptation of the randomization procedure. We establish a connection between the short-term response and the long-term survival through a Bayesian model, first by using prior clinical information, and then by dynamically updating the model according to information accumulated in the ongoing trial. Interim monitoring and final decision making are based upon inference on the primary outcome of survival. The new design uses fewer patients, and can more effectively assign patients to the better treatment arms. We demonstrate these properties through simulation studies.
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Registered trials
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