TABLE A-1 Historical Review of the Biomarker–Surrogate Endpoint Literature with Special Reference to the Nomenclature, Initial Reports, Systems of Classification, and Statistical Methods Developed for Their Evaluation

Year

Author

Focus

Field/Summary and Commentary

1963

Mainland

Nomenclature: Substituted variables

Statistics and Medicine In his Elementary Medical Statistics, he discusses substituting variables that are easy to observe for ones that are difficult to observe.

1966

Rushing

Nomenclature: First report of surrogate used in any context

Psychology, Ethics, Social Science, Law

The role of the hospital nurse as a mother surrogate. (Many publications followed in the 1960s and 1970s where surrogate was used in this context of a person’s role in the fields of psychology, ethics, social science, and law.)

1973

Rho et al.

Nomenclature: First report of biomarker

Biology

A search for porphyrin biomarkers in nonesuch shale and extraterrestrial samples. Biomarker here represents biological marker—origins of biological life.

1976

Schlenger

Nomenclature: First report of surrogate AND outcome

Epidemiology

Mortality and morbidity rates as surrogates for “health.”

1977

Karpetsky et al.

Nomenclature: Second report of biomarker

Oncology

Serum RNase level was found to be an indicator of renal function, and was not a biomarker either for the presence or extent of the plasma cell tumor. (Forty of 46 biomarker reports from 1977 to 1985 were in oncology.)

1978

Baker

Nomenclature: Third report of biomarker

Oncology

Preoperative assessment of the patient with breast cancer.

1980

Regelson

Nomenclature: First report of biomarker outside cancer in medicine

General Medicine

Biomarkers in aging: A beginning for a therapeutic approach in Transactions of the Association of Life Insurance Medical Directors of America.



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