We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Viewpoint |

Biomarkers and Surrogate Endpoints Developing Common Terminology and Definitions

Melissa A. Robb, BSN, MS (RegSci)1; Pamela M. McInnes, DDS, MSc (Dent)2; Robert M. Califf, MD3
[+] Author Affiliations
1Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
2National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland
3US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2016;315(11):1107-1108. doi:10.1001/jama.2016.2240.
Text Size: A A A
Published online


This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common terms and definitions for biomarkers and surrogate endpoints.

Biomarkers, surrogate endpoints, and clinical outcome assessments provide an essential set of tools needed to translate scientific concepts into diagnostic and therapeutic approaches and technologies. Recently, biomarkers have been promoted as offering significant potential for accelerating basic science, drug discovery, and medical product development, as well as improving clinical care.1 Examples of common biomarkers include breast cancer genes 1 and 2, prostate-specific antigen, and hepatitis C virus ribonucleic acid. Although new analytical approaches and omics-based technologies have yielded a rapidly expanding array of biomarkers, precisely how and when they should be used has not been clearly described.

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview




Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

1 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles