CANCER PREVENTION—BIOMARKERS AND SURROGATE ENDPOINTS IN CLINICAL TRIALS

Objectives

  • Examine the advantages and disadvantages of using biomarkers as surrogate endpoints in cancer prevention trials
  • Discuss decision criteria for biomarkers to be considered in clinical trials
  • Consider current options substituting for clinical endpoints in chemoprevention strategies
  • Address statistical considerations for the validation of biomarkers as surrogate endpoints
    • What role does preclinical validation play in establishing surrogate status?
    • What approaches should be considered in the evaluation of multiple surrogate endpoints?
    • What strategies can be used to interpret and analyze "macroscale" biomarker data obtained from high-throughput technologies (e.g., gene expression patterns)?
    • How can statistical modeling incorporating epidemiologic data (including biomarkers) be used in the design of large, randomized clinical trials?
  • Identify research needs for high-throughput, sensitive assay systems for biomarkers
    • What can be done to foster technology development?
    • What resources (e.g., animal models, tissue specimens, sera, genetic and protein data) are needed to ensure the accuracy and precision of novel biomarker assays?

Agenda

Moderators: E. Robert Greenberg, M.D., Dartmouth Medical School
W. Ki Hong, M.D., University of Texas M.D. Anderson Cancer Center

Predictive Markers of Cancer in Smokers
Margaret R. Spitz, M.D., University of Texas M.D. Anderson Cancer Center

Retinoic Acid Receptor Beta as an Intermediate Biomarker in Retinoid Chemoprevention Trials
Reuben Lotan, Ph.D., University of Texas M.D. Anderson Cancer Research Center

Theoretical and Practical Considerations in the Use of Surrogate Endpoints in Cancer Prevention Research
Arthur Schatzkin, M.D., Dr. P.H., National Cancer Institute

Evaluating Chemoprevention Strategies: Multiplicity Issues
Susan S. Ellenberg, Ph.D., Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Biomarkers and Surrogate Endpoints in Breast Cancer Prevention Studies
Barbara S. Hulka, M.D., M.P.H., University of North Carolina

Pharmaceutical Industry Perspectives
David Parkinson, M.D., Novartis Pharmaceuticals Corporation

Discussant: David Sidransky, M.D., Johns Hopkins University School of Medicine

General Discussion

 

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