Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework

Clinical Pharmacology and Therapeutics

Volumn 69, Issue 3, 2001, Pages 89-95

  Atkinson, A J ^a   Colburn, W A ^a   DeGruttola, V G ^a   DeMets, D L ^a   Downing, G J ^a   Hoth, D F ^a   Oates, J A ^a   Peck, C C ^a   Schooley, R T ^a   Spilker, B A ^a   Woodcock, J ^a   Zeger, S L ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; METHOXY ISOBUTYL ISONITRILE TECHNETIUM TC 99M;

DNA MICROARRAY; FOOD AND DRUG ADMINISTRATION; GENE TECHNOLOGY; MASS SPECTROMETRY; NOMENCLATURE; NOTE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; TECHNOLOGY;

ANIMALS; BIOLOGICAL MARKERS; CLINICAL TRIALS; ENDPOINT DETERMINATION; HUMANS; RESEARCH;

EID: 0035100888     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1067/mcp.2001.113989     Document Type: Note

References (29)

1. A survey of the pharmaceutical industry
2. Distinct types of diffuse large B-cell lymphoma identified by gene expression profiling
3. The contribution of clinical pharmacology surrogates and models to drug development: A critical appraisal
4. Efficacy measures: Surrogates or clinical outcomes
5. Slow recovery of human brain MAO B after L-deprenyl (Selegeline) withdrawal
6. Tumor clearance of technetium 99m-sestamibi as a predictor of response to neoadjuvant chemotherapy for locally advanced breast cancer
7. Surrogate markers in AIDS: Where are we? Where are we going?
8. Importance of surrogate markers in evaluation of antiviral therapy for HIV infection
9. Surrogacy in HIV-1 clinical trials
10. A regulatory authority's opinion about surrogate endpoints
11. Surrogate end points in clinical trials: Are we being misled?
12. Mortality and morbidity of patients receiving encainide, flecainide or placebo: The Cardiac Arrhythmia Suppression Trial
13. Surrogate end points, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease
14. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: Final results of the Systolic Hypertension in the Elderly Program (SHEP)
15. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival study (4S)
16. Evaluating novel cardiovascular risk factors: Can we better predict heart attacks?
17. Long-term effects of pravastatin on plasma concentration of C-reactive protein
18. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease
19. Surrogate endpoints: A basis for a rational approach
20. Are surrogate markers adequate to assess cardiovascular disease drugs?
21. New molecular endpoints and methods for routine toxicity testing
22. DNA damage as an intermediate biomarker in intervention studies
23. Estimating the proportion of treatment effect explained by a surrogate marker
24. Statistical validation of intermediate endpoints for chronic diseases
25. Surrogate endpoints
26. Surrogate endpoints in clinical trials: Definition and operational criteria
27. Evaluating surrogate markers
28. Meta-analysis for the evaluation of potential surrogate markers