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Biomarker-driven basket trial designs: origins and new methodological developments
1Department of Population and Public Health Sciences, University of Southern California, Los Angeles, California, USA.
Abstract:
Due to increased use of gene sequencing techniques, understanding of cancer on a molecular level has evolved, in terms of both diagnosis and evaluation in response to initial therapies. In parallel, clinical trials meant to evaluate molecularly-driven interventions through assessment of both treatment effects and putative predictive biomarker effects are being employed to advance the goals of precision medicine. Basket trials investigate one or more biomarker-targeted therapies across multiple cancer types in a tumor location agnostic fashion. The review article offers an overview of the traditional forms of such designs, the practical challenges facing each type of design, and then review novel adaptations proposed in the last few years, categorized into Bayesian and Classical Frequentist perspectives. The review article concludes by summarizing potential advantages and limitations of the new trial design solutions.
Insights
This review explores basket trials for precision medicine, examining traditional designs, challenges, and novel Bayesian and Frequentist adaptations for molecularly-driven cancer therapies.
Area of Science:
- Oncology
- Biostatistics
- Clinical Trial Design
Background:
- Advances in gene sequencing have deepened the molecular understanding of cancer, impacting diagnosis and treatment response assessment.
- Precision medicine aims to tailor treatments using molecularly-driven interventions and predictive biomarkers.
- Basket trials are a key design for evaluating targeted therapies across various cancer types irrespective of tumor location.
Purpose of the Study:
- To provide a comprehensive overview of traditional basket trial designs.
- To identify and discuss practical challenges associated with existing basket trial methodologies.
- To review recent innovative adaptations of basket trials from Bayesian and Classical Frequentist viewpoints.
Main Methods:
- Literature review of traditional and novel basket trial designs.
- Categorization of new adaptations into Bayesian and Classical Frequentist approaches.
- Analysis of practical challenges and proposed solutions for basket trial implementation.
Main Results:
- Traditional basket trial designs and their inherent limitations are presented.
- Novel adaptations, including Bayesian and Frequentist methods, offer potential solutions to design challenges.
- The review synthesizes advancements in evaluating biomarker-targeted therapies.
Conclusions:
- Newer basket trial designs aim to improve the efficiency and effectiveness of precision medicine research.
- Understanding the advantages and limitations of these novel designs is crucial for future clinical trial development.
- These adaptations hold promise for advancing the goals of molecularly-targeted cancer therapy.
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