ArticleClinical cancer research : an official journal of the American Association for Cancer Research2011
Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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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.
- Adaptive Signature Design- review of the biomarker guided adaptive phase -III controlled design.Contemporary clinical trials communications · 2019Review
- Novel two-step derivation method for the synchronous analysis of inherited metabolic disorders using urine.Experimental and therapeutic medicine · 2017Article
- Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.Journal of personalized medicine · 2017Review
- Bayesian Two-stage Biomarker-based Adaptive Design for Targeted Therapy Development.Statistics in biosciences · 2016Article
- Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.PloS one · 2016Review
- Subgroup identification for treatment selection in biomarker adaptive design.BMC medical research methodology · 2015Article
- Advancing Clinical Trials to Streamline Drug Development.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015Article
- Comment.Statistics in biopharmaceutical research · 2015Article
- Rapid learning for precision oncology.Nature reviews. Clinical oncology · 2014Review
- Stratification and partial ascertainment of biomarker value in biomarker-driven clinical trials.Journal of biopharmaceutical statistics · 2014Article
- Drug-diagnostics co-development in oncology.Frontiers in oncology · 2013Review
- Run-in phase III trial design with pharmacodynamics predictive biomarkers.Journal of the National Cancer Institute · 2013Article
- Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.Nature reviews. Drug discovery · 2013Review
- Adaptive enrichment designs for clinical trials.Biostatistics (Oxford, England) · 2013Article
- Fool's gold, lost treasures, and the randomized clinical trial.BMC cancer · 2013Article
- How to develop treatments for biologically heterogeneous "diseases".Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Article
- Modeling and predicting clinical efficacy for drugs targeting the tumor milieu.Nature biotechnology · 2012Review
- Drug development and clinical trials--the path to an approved cancer drug.Nature reviews. Clinical oncology · 2012Review
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4 authors.
Funding
Abstract
A critical challenge in the development of new molecularly targeted anticancer drugs is the identification of predictive biomarkers and the concurrent development of diagnostics for these biomarkers. Developing matched diagnostics and therapeutics will require new clinical trial designs and methods of data analysis. The use of adaptive design in phase III trials may offer new opportunities for matched diagnosis and treatment because the size of the trial can allow for subpopulation analysis. We present an adaptive phase III trial design that can identify a suitable target population during the early course of the trial, enabling the efficacy of an experimental therapeutic to be evaluated within the target population as a later part of the same trial. The use of such an adaptive approach to clinical trial design has the potential to greatly improve the field of oncology and facilitate the development of personalized medicine.
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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.