Surrogate endpoints (biomarkers), that are customarily used in clinical investigate to exam new drugs, should not be devoted as a ultimate magnitude to approve new health interventions in cardiovascular medicine, according to a new investigate by Yale School of Medicine researchers in JAMA.
Biomarkers generally impute to diseases, symptoms, and signs during clinical trials that are compared with other, some-more difficult diseases and symptoms (clinical outcomes).
In a Yale study, lead author and inner medicine proprietor during Yale School of Medicine Dr. Behnood Bikdeli and his colleagues examined a intensity undo between biomarkers and clinical outcomes by screening before publications in a margin of cardiovascular medicine. They found that nonetheless a broker endpoint trials published in a highest-impact journals frequently demonstrated high efficacy of a tested drug, reduction than one third of them had a clinical outcomes hearing of a drug for a same purpose published. Additionally, when there was a successive clinical outcomes trial, approximately half unsuccessful to countenance a certain impact of a drug on a biomarker. Bikdeli records that while a new commentary usually request to a margin of cardiovascular medicine, doctors and researchers in other fields, such as oncology, reason identical reservations about regulating biomarkers to approve new drugs.
Other authors of a investigate are Natdanai Punnanithinont, Yasir Akram, Ike Lee, Nihar R. Desai, Joseph S. Ross, and Harlan M. Krumholz.
Source: Yale University
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