Statistical design and evaluation of biomarker studies

Methods in Molecular Biology

Volumn 1102, Issue , 2014, Pages 667-677

  Dobbin, Kevin K ^a  

^a UNIVERSITY OF GEORGIA   (United States)

Author keywords

Experimental design; Power; Sample size; Translational research

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CLINICAL TRIAL (TOPIC); EXPLORATORY RESEARCH; HUMAN; NONHUMAN; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STATISTICAL ANALYSIS; STUDY DESIGN; TRANSLATIONAL RESEARCH;

ANIMALS; CELL LINE; CLINICAL TRIALS AS TOPIC; HUMANS; RETROSPECTIVE STUDIES; STATISTICS AS TOPIC; TUMOR MARKERS, BIOLOGICAL;

EID: 84891789606     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-62703-727-3_36     Document Type: Article

References (19)

1. Rothberg BEG, Bracken MB, Rimm DL (2009) Tissue biomarkers for prognosis in cutaneous melanoma: A systematic review and meta-analysis. J Natl Cancer Inst 101:452-474
2. Simon R (2010) Clinical trial designs evaluating the medical utility of prognostic and predictive biomarkers in oncology. Per Med 7:33-47
3. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM (2005) Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 97:1180-1184
4. Prentice RL (1989) Surrogate endpoints in clinical trials: Discussion, defi nition and operational criteria. Stat Med 8(4):431-440
5. Friedman LM, Furberg CD, DeMets DL (2010) Fundamentals of clinical trials, 4th edn. Springer, New York
6. Cook TD, DeMets DL (2008) Introduction to statistical methods for clinical trials. Chapman and Hall, New York
7. Fleming TR, DeMets DL (1996) Surrogate end points in clinical trials: Are we being misled? Fleming TR and DeMets DL. Ann Intern Med 125(7):605-613
8. Buyse M, Sargent DJ, Grothey A, Matheson A, de Gramont A (2010) Biomarkers and surrogate end points: The challenge of statistical validation. Nat Rev Clin Oncol 7:309-317
9. Dobbin KK, Beer DG, Meyerson M, Yeatman TJ, Gerald WL, Jacobson JW, Conley B, Buetow KH, Heiskanen M, Simon RM, Minna JD, Girard L, Misek DE, Taylor JMG, Hanash S, Naoki K, Hayes DN, Ladd-Acosta C, Enkemann SA, Viale A, Giordano TJ (2005) Interlaboratory comparability study of cancer gene expression analysis using oligonucleotide microarrays. Clin Cancer Res 11:565-572
10. Shoukri MM (2004) Measures of interobserver agreement. Chapman and Hall, Boca Raton
11. Simon RM, Paik S, Hayes DF (2009) Use of archived specimens to evaluate prognostic and predictive biomarkers. J Natl Cancer Inst USA 101(21):1446-1452
12. Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD (2008) Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 26:1626-1634
13. Karapetis CD, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR (2008) K-RAS mutations and benefi t from cetuximab in advanced colorectal cancer. N Engl J Med 359:1757-1765
14. Dancey JE, Dobbin KK, Groshen S, Jessup JM, Hruszkewicz AH, Koehler M, Parchment R, Ratain MJ, Shankar LK, Stadler WM, True LD, Gravell A, Grever MR, Biomarkers Task Force of the NCI Investigational Drug Steering Committee (2010) Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin Cancer Res 16(6):1745-1755
15. McShane LM, Hunsberger S, Adjei AA (2009) Effective incorporation of biomarkers in phase II trials. Clin Cancer Res 15(6):1898-1905
16. Freidlin B, McShane LM, Korn EL (2009) Randomized clinical trials with biomarkers: Design issues. J Natl Cancer Inst 102:152-160
17. Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M, Shak S, Stewart SJ, Press M (2002) Efficacy and safety of trastuzumumab as a single agent in fi rst-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 20(3): 716-726
18. Sparano JA (2006) TAILORx: Trial assigning individualized options for treatment (Rx). Clin Breast Cancer 7(4):347-350
19. Cardoso F, Van't Veer L, Rutgers E, Loi S, Mook S, Piccart-Gebhart MJ (2008) Clinical application of the 70-gene profi le: The MINDACT trial. J Clin Oncol 26(5): 729-735