Quantitative science methods for biomarker validation in chemoprevention trials

Cancer Biomarkers

Volumn 3, Issue 3, 2007, Pages 135-140

  Freedman, Laurence ^a  

^a BAR ILAN UNIVERSITY   (Israel)

Author keywords

Intermediate endpoints; Meta analysis; Phase II chemoprevention studies; Phase III chemoprevention studies; Prentice's criterion; Surrogate endpoints; Surrogate outcomes

Indexed keywords

BIOLOGICAL MARKER; COLESTYRAMINE; CYTOKINE; PLACEBO; TUMOR MARKER; WART VIRUS VACCINE;

ADENOMATOUS POLYP; CANCER PREVENTION; CANCER RESEARCH; CANCER RISK; CELL PROLIFERATION; CLINICAL TRIAL; COLON CARCINOMA; CONDYLOMA; DISEASE MARKER; HELICOBACTER INFECTION; HUMAN; HYPERCHOLESTEROLEMIA; INFLAMMATORY CELL; LUNG CANCER; MOLECULAR MODEL; MULTIPARA; PRIORITY JOURNAL; QUANTITATIVE STUDY; REVIEW; SMOKING; SOMATIC MUTATION; UTERINE CERVIX CANCER; VALIDATION PROCESS;

EID: 34547120211     PISSN: 15740153     EISSN: None     Source Type: Journal    
DOI: 10.3233/CBM-2007-3304     Document Type: Review

References (21)

1. D.P. Byar, The design of cancer prevention trials, Recent Results Cancer Res 111 (1988), 95-98.
2. M.H. Schiffman, H.M. Bauer, R.N. Hoover, A.G. Glass, D.M. Cadell, B.B. Rush et al., Epidemiologic evidence showing that human papillomavirus infection causes most cervical intraepithelial neoplasia, J Natl Cancer Inst 85 (1993), 958-964.
3. J. MacLean, E.P. Rybicki and A.L. Williamson, Vaccination strategies for the prevention of cervical cancer, Expert Rev Anticancer Ther 5 (2005), 97-107.
4. A. Schatzkin and M. Gail, The promise and peril of surrogate end points in cancer research, Nat Rev Cancer 2 (2002), 19-27.
5. R.L. Prentice, Surrogate endpoints in clinical trials: Definition and operational criteria, Stat Med 8 (1989), 431-440.
6. A. Schatzkin, L.S. Freedman, M.H. Schiffman and S.M. Dawsey, Validation of intermediate end points in cancer research, J Natl Cancer Inst 82 (1990), 1746-1752.
7. L.S. Freedman, B.I. Graubard and A. Schatzkin, Statistical validation of intermediate endpoints for chronic diseases, Stat Med 11 (1992), 167-178.
8. M. Buyse and G. Molenberghs, Criteria for the validation of surrogate endpoints, Biometrics 54 (1998), 1014-1029.
9. P.W. Bycott and J.M. Taylor, An evaluation of a measure of the proportion of the treatment effect explained by a surrogate marker, Control Clin Trials 19 (1998), 555-568.
10. P. Flandre and Y. Saidi, Estimating the proportion of treatment effect explained by a surrogate marker, Stat Med 18 (1999), 107-109.
11. G. Molenberghs, M. Buyse, H. Geys, D. Renard, T. Burzykowski and A. Alonso, Statistical challenges in the evaluation of surrogate endpoints in randomized trials, Control Clin Trials 23 (2002), 607-625.
12. J. Benichou, Attributable Risk, in: Encyclopedia of Biostatistics, 2nd, P. Armitage and T. Colton, eds, edition, Wiley, Chichester, UK, pp. 249-262.
13. J.M. Walboomers, M.V. Jacobs, M.M. Manos, F.X. Bosch, J.A. Kummer, K.V. Shah et al., Human papillomavirus is a necessary cause of invasive cervical cancer worldwide, J Pathol 189 (1999), 12-19.
14. A. Schatzkin, L.S. Freedman, S.M. Dawasey and E. Lanza, Interpreting precursor studies: What polyp trials tell us about large-bowel cancer, J Natl Cancer Inst 86 (1994), 1053-1057.
15. J.A. Baron, M. Beach, J.S. Mandel, R.U. Van Stolk, R.W. Halle, R.S. Sandler, R. Rothstein, R.W. Summers, D.C. Shover, G.J. Beck, J.H. Bond and E.R. Greenberg, Calcium supplements for the prevention of colorectal adenomas. Calcium Polyp Prevention Study Group, N Engl J Med 340 (1999), 101-107.
16. A. Schatzkin, E. Lanza, L.S. Freedman, J. Tangrea, M.R. Cooper, J.R. Marshall, P.A. Murphy, J.V. Selby, M. Shike, R.R. Schade, R.W. Burt, J.W. Kikendall and J. Cahill, The polyp prevention trial I: Rationale, design, recruitment, and baseline participant characteristics, Cancer Epidemiol Biomarkers Prev 5 (1996), 375-383.
17. M.J. Daniels and M.D. Hughes, Meta-analysis for the evaluation of potential surrogate markers, Stat Med 16 (1997), 1965-1982.
18. M.H. Gail, R. Pfeffer, H. Van Houwelingen and R.J. Carroll, On meta-analytic assessment of surrogate outcomes, Biostatistics 1 (2000), 231-246.
19. G. Molenberghs, H. Geys and M. Buyse, Evaluation of surrogate endpoints in randomized experiments with mixed discrete and continuous outcomes, Stat Med 20 (2001), 3023-3038.
20. E.L. Korn, P.S. Alberts and L.M. McShane, Assessing surrogates as trial endpoints using mixed models, Stat Med 24 (2005), 163-182.
21. T. Burzykowski, G. Molenberghs and M. Buyse, eds, The Evaluation of Surrogate Endpoints, Springer Verlag, New York, 2005.