Biomarkers, putative surrogates, surrogates, and decision making

Circulation: Cardiovascular Imaging

Volumn 6, Issue 1, 2013, Pages 6-7

  Califf, Robert M ^a  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Biomarkers; Decision making; Editorials

Indexed keywords

BIOLOGICAL MARKER; GLUCOSE; LIPID;

ARTERIAL WALL THICKNESS; ATHEROSCLEROSIS; BIOLOGICAL PHENOMENA AND FUNCTIONS CONCERNING THE ENTIRE ORGANISM; BLOOD PRESSURE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); DECISION MAKING; DRUG COST; DRUG DEVELOPMENT; EDITORIAL; FUNCTIONAL STATUS; GLUCOSE BLOOD LEVEL; HUMAN; LONGEVITY; MEASUREMENT; MEDICAL LITERATURE; PRIORITY JOURNAL; PUBLISHING; RISK REDUCTION; TREATMENT OUTCOME; CAROTID ARTERY; ECHOGRAPHY; METHODOLOGY; NOTE; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ATHEROSCLEROSIS; CAROTID ARTERIES; CAROTID INTIMA-MEDIA THICKNESS; DECISION MAKING; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84874524914     PISSN: 19419651     EISSN: 19420080     Source Type: Journal    
DOI: 10.1161/CIRCIMAGING.112.982538     Document Type: Editorial

References (9)

1. Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov. 2010;9:203-214.
2. President's Council of Advisors on Science and Technology. Report to the president on propelling innovation in drug discovery, development, and evaluation. 2012. http://www.whitehouse.gov/sites/default/fles/microsites/ostp/ pcast-fda-fnal.pdf. Accessed December 10, 2012.
3. Peters SAE, den Ruijter HM, Grobbee DE, Bots ML. Results from a carotid intima-media thickness trial as a decision tool for launching a large scale morbidity and mortality trial. Circ Cardiovasc Imaging. 2013;6:20-25.
4. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125:605-613.
5. Institute of Medicine. Evaluating and regulating biomarker use. In: Micheel CM, Ball JR, eds. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: National Academies Press; 2010. http://www.iom.edu/Reports/2010/Evaluation-of-Biomarkers-and-Surrogate- Endpoints-in-Chronic-Disease.aspx. Accessed December 10, 2012.
6. Prentice RL. Surrogate endpoints in clinical trials: defnition and operational criteria. Stat Med. 1989;8:431-440.
7. Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA. 2012;307:1861-1864.
8. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292.
9. Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes. 2012;5:238-240.