What question did this study set out to answer?

Review key design considerations for evaluating predictive cancer markers and formulate rigorous clinical trial architectures to assess their therapeutic utility.

March 18, 2005Journal of Clinical Oncology

Clinical Trial Designs for Predictive Marker Validation in Cancer Treatment Trials

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Authors

DSDaniel J. SargentUniversity of Siena BCBarbara A. ConleyNational Cancer Institute CACarmen J. AllegraUniversity of Florida Health

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Implication

Methodological review demonstrates clinical trial frameworks for validating predictive cancer biomarkers, highlighting optimal designs for biomarker-guided oncology therapies.

Key Points

Review key design considerations for evaluating predictive cancer markers and formulate rigorous clinical trial architectures to assess their therapeutic utility.
Characterized the Marker by Treatment Interaction Design, which evaluates differential treatment efficacy through upfront stratification by marker status.
Characterized the Marker-Based Strategy Design, which randomizes patients to receive therapy determined by marker status versus therapy assigned independently of marker status.
Performed sample size and power calculations for representative oncology scenarios to compare design efficiency and feasibility.
Marker by Treatment Interaction designs directly estimate interaction effects between marker subgroups and assigned treatments within classical randomized settings.
Marker-Based Strategy designs determine the overall population-level clinical utility of adopting a biomarker-driven therapeutic decision strategy over standard care.
Optimal design selection depends on clinical context, including the necessity of evaluating interaction effects, ethical assignment to non-marker-guided therapy, and sample size constraints.

Cite This Study

Sargent et al. (2005) studied this question.

synapsesocial.com/papers/6a0cdfb37aad2cc6fd1f5bb8 https://doi.org/10.1200/jco.2005.01.112

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Implication

Methodological review demonstrates clinical trial frameworks for validating predictive cancer biomarkers, highlighting optimal designs for biomarker-guided oncology therapies.

Clinical Trial Designs for Predictive Marker Validation in Cancer Treatment Trials

Discussion

Member takes

Implication

Key Points

Cite This Study

Clinical Trial Designs for Predictive Marker Validation in Cancer Treatment Trials

Discussion

Member takes

Implication

Key Points

Cite This Study

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