Phase III clinical trials that integrate treatment and biomarker evaluation.

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

19 citing papers in PubMed.

1. DNA Methylation as Drug Sensitivity Marker in RCC: A Systematic Review.Epigenomes · 2024
   Review
2. Efficient testing of the biomarker positive and negative subgroups in a biomarker-stratified trial.Biometrics · 2024
   Article
3. A scoping review of statistical methods in studies of biomarker-related treatment heterogeneity for breast cancer.BMC medical research methodology · 2023
   Article
4. Design and reporting of phase III oncology trials with prospective biomarker validation.Journal of the National Cancer Institute · 2023
   Article
5. Precision tyrosine kinase inhibitor dosing in chronic myeloid leukemia?Haematologica · 2019
   Article
6. Biomarker-Driven Oncology Clinical Trials: Key Design Elements, Types, Features, and Practical Considerations.JCO precision oncology · 2019
   Review
7. Phase III Precision Medicine Clinical Trial Designs That Integrate Treatment and Biomarker Evaluation.JCO precision oncology · 2019
   Review
8. Accelerating Therapeutic Development through Innovative Trial Design in Colorectal Cancer.Current treatment options in oncology · 2018
   Review
9. Fixed and Adaptive Parallel Subgroup-Specific Design for Survival Outcomes: Power and Sample Size.Journal of personalized medicine · 2017
   Article
10. The Challenge for Development of Valuable Immuno-oncology Biomarkers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Article
11. Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.Journal of personalized medicine · 2017
    Review
12. Value-based and benefit-based strategies in deciding to bring a test into use should be distinguished.Diagnostic and prognostic research · 2017
    Article
13. Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.PloS one · 2016
    Review
14. The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.Computational and mathematical methods in medicine · 2015
    Article
15. Marker Sequential Test (MaST) design.Clinical trials (London, England) · 2014
    Article
16. Biomarker enrichment strategies: matching trial design to biomarker credentials.Nature reviews. Clinical oncology · 2014
    Review
17. Drug-diagnostics co-development in oncology.Frontiers in oncology · 2013
    Review
18. Evaluating many treatments and biomarkers in oncology: a new design.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013
    Article
19. Statistical and practical considerations for clinical evaluation of predictive biomarkers.Journal of the National Cancer Institute · 2013
    Article

Corrections and comments

• Commented on by
  Some practical considerations for phase III studies with biomarker evaluations.2014
• Commented on by
  Reply to S. Goteti et al.2014

Authors and funding

4 authors.

Funding

Abstract

PubMed holds no abstract for this paper.

Indexed as