ReviewJournal of personalized medicine2017
Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.
Review in Journal of personalized medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 25 papers, 1 of them a synthesis that pooled it.
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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Design and analysis of umbrella trials: Where do we stand?Frontiers in medicine · 2022Pooled it
- Smart nanoparticle delivery systems for curcumin: a targeted strategy to enhance anticancer efficacy and bioavailability.Journal of materials science. Materials in medicine · 2026Review
- Biomarker-guided adaptive enrichment design with threshold detection for clinical trials with time-to-event outcome.Journal of biopharmaceutical statistics · 2025Article
- Interpreting results from biomarker-guided clinical trials: avoiding "negative" or "failed" terminology.BMC medicine · 2025Article
- The PERMIT guidelines for designing and implementing all stages of personalised medicine research.Scientific reports · 2024Article
- Alpha-fetoprotein, glypican-3, and kininogen-1 as biomarkers for the diagnosis of hepatocellular carcinoma.International journal of clinical and experimental pathology · 2024Review
- Study designs for clinical trials applied to personalised medicine: a scoping review.BMJ open · 2022Article
- Article
- Can Systems Biology Advance Clinical Precision Oncology?Cancers · 2021Review
- Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial.BMC cancer · 2021Article
- Translational precision medicine: an industry perspective.Journal of translational medicine · 2021Review
- Time to reality check the promises of machine learning-powered precision medicine.The Lancet. Digital health · 2020Article
- Transforming clinical trials in rheumatology: towards patient-centric precision medicine.Nature reviews. Rheumatology · 2020Review
- Modeling neuroaffective biomarkers of drug addiction: A Bayesian nonparametric approach using dirichlet process mixtures.Journal of neuroscience methods · 2020Article
- Specific requirements for translation of biological research into clinical radiation oncology.Molecular oncology · 2020Review
- How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development.Micromachines · 2020Article
- Biomarker-guided trials: Challenges in practice.Contemporary clinical trials communications · 2019Article
- Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials.Journal of personalized medicine · 2019Review
- Effects of biomarker diagnostic accuracy on biomarker-guided phase 2 trials.Contemporary clinical trials communications · 2019Article
- Adaptive Signature Design- review of the biomarker guided adaptive phase -III controlled design.Contemporary clinical trials communications · 2019Review
Corrections and comments
- Erratum issued
Authors and funding
3 authors.
Funding
Abstract
Biomarker-guided treatment is a rapidly developing area of medicine, where treatment choice is personalised according to one or more of an individual's biomarker measurements. A number of biomarker-guided trial designs have been proposed in the past decade, including both adaptive and non-adaptive trial designs which test the effectiveness of a biomarker-guided approach to treatment with the aim of improving patient health. A better understanding of them is needed as challenges occur both in terms of trial design and analysis. We have undertaken a comprehensive literature review based on an in-depth search strategy with a view to providing the research community with clarity in definition, methodology and terminology of the various biomarker-guided trial designs (both adaptive and non-adaptive designs) from a total of 211 included papers. In the present paper, we focus on non-adaptive biomarker-guided trial designs for which we have identified five distinct main types mentioned in 100 papers. We have graphically displayed each non-adaptive trial design and provided an in-depth overview of their key characteristics. Substantial variability has been observed in terms of how trial designs are described and particularly in the terminology used by different authors. Our comprehensive review provides guidance for those designing biomarker-guided trials.
Indexed as
Identifiers
What OpenQuestion holds
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.