NIH Publications on Biomarkers and Surrogate Endpoints

• Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 2001;69:89-95 (105 KB)
• Considerations in the evaluation of surrogate endpoints in clinical trials: Summary of a National Institutes of Health workshop. Controlled Clinical Trials 2001; 22:485–502 (143 KB)
• Information on the conference proceedings Biomarkers and Surrogate Endpoints: Clinical Research and Applications maybe obtained from Elsevier Scientific.

Biomarkers and Surrogate Endpoints in Clinical Trials

• Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications—An NIH-FDA Conference, April 15–16, 1999
• Research Needs for the Design and Analysis of Surrogate Endpoints in Clinical Trials—An NIH Workshop, December 1–2, 1999

Biomarker Knowledge Systems

• Summary of Biomarkers Knowledge System Meeting—September 8, 2000 (126 KB)

NIH Biomarker Research Programs

• NCI Early Detection Research Network Biomarkers Program
• NHLBI RFA (Release Date: June 22, 2000)
• NICHD PA (Release Date: January 18, 2001)

Other Federal Research Agencies

• Biomarkers for the Assessment of Exposure and Toxicity in Children—National Center for Environmental Research, Environmental Protection Agency

Recent Presentations

• July 11, 2000 Presentation at Toxicology Forum
• May 1, 2000 Presentation at the Drug Information Association
• March 1, 2000 Presentation at FDA, Center for Drug Evaluation and Research
• February 23, 2000 Presentation at International Conference on Drug Development

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