Surrogate end points in women's health research: science, protoscience, and pseudoscience.
A surrogate end point (e.g., a laboratory test or image) serves as a proxy for a clinical end point of importance (e.g., fracture, thrombosis, or death). Adoption and use of surrogate end points lacking validation, especially in cardiovascular medicine, have caused thousands of patients' deaths, a serious violation of the ethical principle of beneficence.
David A
DA
Grimes
Kenneth F
KF
Schulz
Elizabeth G
EG
Raymond
D015415:Biomarkers / Q000032:analysis*; D005260:Female; D006287:Health Planning Guidelines; D006801:Humans; D012106:Research / Q000592:standards* / Q000639:trends; D012107:Research Design; D012586:Science / Q000379:methods / Q000592:standards* / Q000639:trends; D054928:Validation Studies as Topic; D016387:Women's Health
D015415:Biomarkers