Methods of Marker Development: Literature Resources

CCR Focus

Clinical Cancer Research 18(6) March 15, 2012

• Molecular Diagnostics: Are We There Yet?
  Susan E. Bates
  Clin Cancer Res 18: 1514
• Leveling the Playing Field: Bringing Development of Biomarkers and Molecular Diagnostics up to the Standards for Drug Development
  George Poste, David P. Carbone, David R. Parkinson, Jaap Verweij, Stephen M. Hewitt, and J. Milburn Jessup
  Clin Cancer Res 18(6): 1515-1523
• Impact of Preanalytic Factors on the Design and Application of Integral Biomarkers for Directing Patient Therapy
  Stephen M. Hewitt, Sunil S. Badve, and Lawrence D. True
  Clin Cancer Res; 18(6): 1524–1530
• Bridging the Gap: Moving Predictive and Prognostic Assays from Research to Clinical Use
  P. Michael Williams, Tracy G. Lively, J. Milburn Jessup, and Barbara A. Conley
  Clin Cancer Res; 18(6): 1531–1539
• Development and Use of Integral Assays in Clinical Trials
  Richard L. Schilsky, James H. Doroshow, Michael LeBlanc, and Barbara A. Conley
  Clin Cancer Res 18(6): 1540-1546
• Lessons Learned from the Investigational Device Exemption Review of Children’s Oncology Group Trial AAML1031
  Soheil Meshinchi, Stephen P. Hunger, Richard Aplenc, Peter C. Adamson, and J. Milburn Jessup
  Clin Cancer Res; 18(6): 1547–1554
• Biomarker Discovery, Development, and Implementation in France: A Report from the French National Cancer Institute and Cooperative Groups
  Fabrice Andre, Frederique Nowak, Monica Arnedos, Ludovic Lacroix, Patrice Viens, and Fabien Calvo
  Clin Cancer Res; 18(6): 1555–1560

Additional Resources

• Hayes, DF, Trock B, Harris AL. Assessing the clinical impact of prognostic factors: When is "statistically significant" clinically useful? Breast Cancer Res and Treatment 52: 305-19, 1998.
• McGuire, WL. Breast cancer prognostic factors: Evaluation guidelines. J Natl Cancer Inst 83(3): 154-5, 1991.
• Levine MN, Browman GP, Gent M, Roberts R, Goodyear M. When is a prognostic factor useful?: A guide for the perplexed. J. Clin Oncol 9(2): 348-56, 1991.
• Tosteson, ANA, Weinstein MC, Wittenbert, J, Begg CB. ROC Curve regression analysis: the use of ordinal regression models for diagnostic test assessment. Environmental Health Perspectives102 supp 8, 73-8, 1994.
• Simon R and Altman DG. Statistical aspects of prognostic factor studies in oncology. Br. J Cancer 69: 979-85, 1994.
• Fleming TR and DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Int Med 125: 605-13, 1996.
• Lin DY, Fleming TR and De Gruttola V. Estimating the proportion of treatment effect explained by a surrogate marker. Statistics in Medicine 16: 1515-27, 1997.
• Hayes DF, Bast RC, Desch CE, Fritsche H, Kemeny NE, Jessup JM, Locker GY, Macdonald JS, Mennel RG, Norton L, Ravdin P, Taube S, Winn RJ. Tumor Marker Utility Grading System: A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 88(20): 1456-66, 1996.
• Charleson ME, Ales KL, Simon R, MacKenzie CR. Why predictive indexes perform less well in validation studies: Is it magic or methods? Arch Intern Med 147: 2155-61, 1987.
• Gasparini G, Gion M. Molecular-targeted anticancer therapy: Challenges related to study design and choice of proper endpoints. The Cancer Journal 6(3): 117-31, 2000.
• Golub TR, Slonim DK, Tamayo P, Huard C, Gaasenbeek M, Mesirov JP, Coller H, Loh ML, Downing JR, Caligiuri MA, Bloomfield CD, Lander ES. Molecular classification of cancer: Class discovery and class prediction by gene expression monitoring. Science 286: 531-36, 1999.
• Eisen MB, Spelllman PT, Brown PO, Botstein D. Cluster analysis and display of genome-wide expression patterns. PNAS 95(25) 14863-68, 1998.