Early-phase studies of biomarkers: What target sensitivity and specificity values might confer clinical utility?

Clinical Chemistry

Volumn 62, Issue 5, 2016, Pages 737-742

  Pepe, Margaret S ^a   Janes, Holly ^a   Li, Christopher I ^b   Bossuyt, Patrick M ^c   Feng, Ziding ^d   Hilden, Jørgen ^e  

^a Public Health Sciences Division   (United States)

^b USA   (United States)

^c UNIVERSITY OF AMSTERDAM   (Netherlands)

^d UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^e UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

TUMOR MARKER;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER DIAGNOSIS; CANCER RECURRENCE; CANCER SCREENING; CANCER STAGING; COLON CANCER; COST BENEFIT ANALYSIS; DECISION THEORY; FALSE POSITIVE RESULT; FEMALE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MAMMOGRAPHY; OVARY CANCER; PREVALENCE; SENSITIVITY AND SPECIFICITY; TRANSVAGINAL ECHOGRAPHY; BREAST NEOPLASMS; COLONIC NEOPLASMS; MIDDLE AGED; OVARIAN NEOPLASMS;

AGED; BIOMARKERS, TUMOR; BREAST NEOPLASMS; COLONIC NEOPLASMS; FEMALE; HUMANS; MIDDLE AGED; OVARIAN NEOPLASMS; SENSITIVITY AND SPECIFICITY;

EID: 84964833227     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2015.252163     Document Type: Article

References (20)

1. Feng Z, Kagan J, Pepe M, Thornquist M, Rinaudo J, Dahlgren J, et al. Early detection research network spec-imenreference sets:paving the way forrapidevaluation of potential biomarkers. Clin Chem 2013;59:68-74.
2. Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter JD. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design. J Natl Cancer Inst 2008;100:1432-8.
3. Pepe MS, Li CI, Feng Z. Improving the quality of bio-marker discovery research: the right samples and enough of them. Cancer Epidemiol Biomarkers Prev 2015;24:944-50.
4. Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, et al. Phases of biomarker development for early detectionofcancer.JNatl Cancer Inst 2001;93: 1054-61.
5. Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making 2006;26:565-74.
6. Pepe MS. The statistical evaluation of medical tests for classification and prediction. Oxford: Oxford University Press; 2003.
7. Pauker SG, Kassirer JP. Therapeutic decision making: a cost-benefit analysis. N Engl J Med 1975;293:229-34.
8. American Cancer Society. Colorectal cancer. http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-survival-rates (Accessed August 2015).
9. Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Tangen CM, et al. Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report. Ann Intern Med 1995; 122:321-6.
10. U.S. Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2009;151: 715-26.
11. American Cancer Society. Breast Cancer. http://www. cancer.org/Cancer/BreastCancer/DetailedGuide/index (Accessed August 2015).
12. Bennett RL, Sellars SJ, Moss SM. Interval cancers in the NHS breast cancer screening programme in England, Wales and Northern Ireland. Br J Cancer 2011;104: 571-7.
13. Bucchi L, Ravaioli A, Foca F, Colamartini A, Falcini F, Naldoni C. Incidence of interval breast cancers after 650, 000 negative mammographies in 13 Italian health districts. J Med Screen 2008;15:30-5.
14. Menon U, Gentry-Maharaj A, Hallett R, et al. Sensitivity and specificityofmultimodal andultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKC-TOCS). Lancet Oncol 2009;10:327-40.
15. Howlader N, Noone AM, Krapcho M, Garshell J, Miller D, Altekruse SF, et al., editors. SEER Cancer Statistics Review, 1975-2011. Bethesda (MD): National Cancer Institute. http://seer.cancer.gov/archive/csr/1975-2011/(Accessed March 2016).
16. Skates SJ, Gillette MA, LaBaer J, Carr SA, Anderson NL, Liebler DC, et al. Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies. J Proteome Res 2013;12:5383-94.
17. Fitzgerald M, Saville BR, Lewis RJ. Decision curve analysis. JAMA 2015;313:409-10.
18. Pepe MS, Janes HE. Gauging the performance of SNPs, biomarkers and clinical factors for predicting risk of breast cancer. J Natl Cancer Inst 2008;100: 978-9.
19. Pepe MS, Janes H, Li CI. Net risk reclassification p-values: valid or misleading? J Natl Cancer Inst 2014; 107:355.
20. Vickers AJ, Pepe MS. Does the net reclassification improvement help us evaluate models and markers? Ann Intern Med 2014;60:136-7.