RESEARCH STRATEGIES, STUDY DESIGNS AND STATISTICAL APPROACHES TO BIOMARKERS VALIDATION FOR CANCER DIAGNOSIS AND DETECTION

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Meeting Dates:
July 28-29, 2004

Meeting Site:
Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878
(301) 590-0044
www.gaithersburgmarriott.com

Mission:
The National Cancer Institute in cooperation with the Food and Drug Administration (FDA), invite you to participate in the workshop to be held in Gaithersburg, MD on July 28-29, 2004. The workshop is designed to review the basic considerations underpinning the study design, statistical methodologies and validation approaches to rapidly advancing field of cancer biomarker and consider approaches to their validation for clinical utility, including randomized controlled-trial (RCT)- based and non-RCT based validation designs.

Invited speakers and discussion panelists will address the various aspects of biomarker validation: high throughput, high-dimensional data analysis deriving from genomic and proteomic technologies and statistical considerations on study designs for data collection including preprocessing of data.

The workshop participants will also discuss the FDA guidelines for technology and biomarker evaluation, analytical performance characteristics, biomarker validation regulatory requirements for commercialization, unconventional approaches to data validation and analysis, approaches to piggybacking validation study to ongoing prevention and treatment trials, case-control study designs based on completed trials, and suitability of samples for proteomics and genomic assays for validation study;

A major goal of this workshop is to stimulate discussions related to statistical considerations of cancer biomarker validation for cancer detection and diagnosis and to develop a position paper on state-of-the-art in biomarker validation study.