Commentary
Clinical Pharmacology & Therapeutics (2001) 69, 89–95; doi: 10.1067/mcp.2001.113989
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework*
Biomarkers Definitions Working Group
Arthur J. Atkinson Jr MD1, Wayne A. Colburn PhD, MDS2, Victor G. DeGruttola ScD3, David L. DeMets PhD4, Gregory J. Downing DO, PhD5, Daniel F. Hoth MD6, John A. Oates MD7, Carl C. Peck MD8, Robert T. Schooley MD9, Bert A. Spilker PhD, MD10, Janet Woodcock MD11 and Scott L. Zeger PhD12
- 1Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Md.
- 2MDS Harris, Inc, Phoenix, Ariz.
- 3Harvard School of Public Health, Boston, Mass.
- 4Departmentof Biostatistics, University of Wisconsin, Madison, Wis.
- 5Office of Science Policy National Institutes of Health, Bethesda, Md.
- 6Axys Pharmaceuticals, SSan Francisco, Calif.
- 7Department of Medicine, Vanderbilt University, Nashville, Tenn.
- 8Center for Drug Development Science, Georgetown University, Washington, DC.
- 9Department of Medicine, University of Colorado, Health Sciences Center, Denver, Colo.
- 10Pharmaceutical Research and Manufacturers of America, Washington, DC.
- 11Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Md.
- 12Department of Biostatistics, Johns Hopkins University, School of Public Health and Hygiene, Baltimore, Md.
Correspondence: Downing, Gregory J. DO, PhD, Office of Science Policy, NIH, Bldg 1, Rm 218, One Center Drive, Bethesda, MD 20892 E-mail: downingg@od.nih.gov.
*Portions of this article were previously published as a conference proceedings report: Downing GJ, editor. Biomarkers and surrogate endpoints: clinical research and applications. Amsterdam: Elsevier Scientific; 2000. p. 1-7.
Received 14 November 2000; Accepted 31 December 2000.
