Year

Author

Focus

Field/Summary and Commentary

 

Webb and Lin

Nomenclature: First report of biomarker in title of publication

Oncology

Urinary fibronectin: Potential as a biomarker in prostatic cancer.

1982

Waalkes et al.

Biomarkers for clinical application

Oncology

Feasibility study in the development of 17 biological markers for ovarian cancer.

1983

Wood

Nomenclature: First report of surrogate AND endpoint, second report of surrogate AND outcome

Rheumatology

Nature of surrogate endpoints. Relationships considered at two levels: (1) ability of the attribute to act as a surrogate in detection of the underlying state (at a particular point in time); (2) potential of the surrogate to reveal changes in the underlying state as its course unfolds.

1986

Bigger

Second surrogate and endpoint, third surrogate and outcome

Cardiology

Electrophysiological testing to select patients with ventricular arrhythmias for drug trials and to determine anti-arrhythmic drug efficacy. (By the end of the decade, the use of biomarkers as surrogates in cardiology had a number of high-profile failures.)

 

Buccheri et al.

First report of biomarker as measure of tumor burden and predict outcome

Oncology

Clinical value of a multiple biomarker assay (CEA, TPA, b-HCG, LDH) in patients with bronchogenic carcinoma.

1987

Kalish et al.

Third surrogate and endpoint

Oncology

Surrogates as endpoints in bladder cancer trials. Data show that superficial disease endpoints do not predict surrogates for invasive disease endpoints.

 

Schulof et al.

Surrogates markers first used as response to therapy

HIV

Phase I/II trial of thymosin fraction 5 and thymosin alpha one in HTLV-III–seropositive subjects.



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