Trial reportAnnals of translational medicine2022
Challenges and opportunities in biomarker-driven trials: adaptive randomization.
Trial report in Annals of translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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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
4 citing papers in PubMed.
- Therapy as a State-Generator: Dynamic Phenotypic Landscapes and Adaptive Stress Circuits in Chemotherapy Resistance of Breast Cancer.Antioxidants (Basel, Switzerland) · 2026Review
- Ozone therapy in femoral head necrosis: a perspective on biomarker-guided treatment rationalization and mechanistic exploration.Frontiers in medicine · 2026Article
- MARGO: Machine Learning-Assisted Adaptive Randomization for Group Sequential Trials Based on Overlap Weights.Statistics in medicine · 2025Article
- Personalized Risk-Based Screening Design for Comparative Two-Arm Group Sequential Clinical Trials.Journal of personalized medicine · 2022Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In an era of precision medicine, as advanced technology such as molecular profiling at individual patient level has been developed and become increasingly accessible and affordable, biomarker-driven trials have been received a lot of attention and are expected to receive more attention in order to integrate clinical practice with clinical research. Biomarkers play a critical role to identify patients who are expected to get benefit from a treatment, and it is important to effectively incorporate the biomarkers into clinical trials to understand the biomarker-treatment relationship and increase the efficiency. We investigate incorporating biomarkers in adaptive randomization to identify patients who would respond better to the treatment and optimize the treatment allocation. The covariate-adjusted variants of the existing response-adaptive randomization are used to implement biomarker-driven randomization, and the performance of the biomarker-driven randomization is compared with the existing randomization methods, such as traditional fixed randomization with equal probability and response-adaptive randomization without incorporating biomarkers, under the group sequential design allowing early stopping due to superiority and futility. Various scenarios are taken into account to see the impact of the biomarker-driven randomization in the simulation study. It shows that the overall type I error rate is likely to be inflated by the effect of prognostic biomarkers. Several suggestions and considerations for the challenges are discussed to maintain the type I error rate at the nominal level.
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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.