Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You and Your Team.

Learn More →

Surrogate Outcomes in Clinical Trials

Surrogate Outcomes in Clinical Trials VIEWPOINT A Cautionary Tale URROGATE OUTCOMES in particular, their ubiquity in day- WILL HISTORY are often used as prox- to-day clinical work and their power REPEAT ITSELF? ies for hard clinical out- to confer an often false sense of un- comes, as they enable derstanding and control. There are reasons to hope that the S smaller, faster, and thus Surrogate measurement is a rou- situation may improve. On the one cheaper clinical trials. In addition, tine part of clinical practice; for ex- hand, lessons from the rosiglita- pharmaceutical companies argue that ample, using hemoglobin A to 1c zone debacle have recently led the using surrogates means that fewer pa- monitor diabetes mellitus therapy US Food and Drug Administration tients are exposed during testing, and means that short-term effects of to push companies to conduct clini- beneficial new medications reach the treatment are visible, whereas the cal trials with hard clinical end market faster. Their main disadvan- true outcomes may be years into the points for new oral hypoglyce- tage is that favorable effects on sur- future. This situation confuses the mics. On the other hand, newer rogates do not automatically trans- actual disease and its surrogate, and drugs in http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Surrogate Outcomes in Clinical Trials

Loading next page...
 
/lp/american-medical-association/surrogate-outcomes-in-clinical-trials-wNU8CD3jEu
Publisher
American Medical Association
Copyright
Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2013.3037
pmid
23529157
Publisher site
See Article on Publisher Site

Abstract

VIEWPOINT A Cautionary Tale URROGATE OUTCOMES in particular, their ubiquity in day- WILL HISTORY are often used as prox- to-day clinical work and their power REPEAT ITSELF? ies for hard clinical out- to confer an often false sense of un- comes, as they enable derstanding and control. There are reasons to hope that the S smaller, faster, and thus Surrogate measurement is a rou- situation may improve. On the one cheaper clinical trials. In addition, tine part of clinical practice; for ex- hand, lessons from the rosiglita- pharmaceutical companies argue that ample, using hemoglobin A to 1c zone debacle have recently led the using surrogates means that fewer pa- monitor diabetes mellitus therapy US Food and Drug Administration tients are exposed during testing, and means that short-term effects of to push companies to conduct clini- beneficial new medications reach the treatment are visible, whereas the cal trials with hard clinical end market faster. Their main disadvan- true outcomes may be years into the points for new oral hypoglyce- tage is that favorable effects on sur- future. This situation confuses the mics. On the other hand, newer rogates do not automatically trans- actual disease and its surrogate, and drugs in

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Apr 22, 2013

References