Biomarker Validation Through Statistical Techniques

Key takeaways:

The use of biomarkers and surrogate endpoints in drug development.
The concepts of prognostic/predictive biomarkers and surrogate endpoints.
The statistical techniques, criteria and study designs appropriate for the clinical validation of these various types of biomarkers

Speakers:

Marc Buyse, ScD

Founder, Chief Executive Officer, and Chief Scientific Officer

Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe. He is interested in clinical trial design, meta-analysis, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and fraud, statistical monitoring of clinical trials, and medical data sharing (http://publicationslist.org/marc.buyse)

Tomasz Burzykowski, Ph.D.

VP, Research

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Statistical Validation of Biomarkers

June 22, 2010

Key takeaways:

Speakers:

Marc Buyse, ScD

Tomasz Burzykowski, Ph.D.

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When every data point represents a patient, accuracy and integrity aren’t optional — they’re everything. That’s why it’s IDDI.