ACS (American Cancer Society). 2011. Colorectal cancer facts and figures, 2011–2013. Atlanta, GA: American Cancer Society.
ACS. 2012. Cancer facts and figures, 2012. Atlanta, GA: American Cancer Society.
Altman, D. G., I. Simera, J. Hoey, D. Moher, and K. Schulz. 2008. EQUATOR: Reporting guidelines for health research. Lancet 371(9619):1149–1150.
Altman, D. G., L. M. McShane, W. Sauerbrei, and S. E. Taube. 2012. Reporting recommendations for tumor marker prognostic studies (REMARK): Explanation and elaboration. PLoS Medicine 9(5):e1001216.
Andre, F., L. M. McShane, S. Michiels, D. F. Ransohoff, D. G. Altman, J. S. Reis-Filho, D. F. Hayes, and L. Pusztai. 2011. Biomarker studies: A call for a comprehensive biomarker study registry. Nature Reviews Clinical Oncology 8(3):171–176.
Baggerly, K. A., and K. R. Coombes. 2009. Deriving chemosensitivity from cell lines: Forensic bioinformatics and reproducible research in high-throughput biology. Annals of Applied Statistics 3(4):1309–1334.
Bristow, R. E., R. S. Tomacruz, D. K. Armstrong, E. L. Trimble, and F. J. Montz. 2002. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: A meta-analysis. Journal of Clinical Oncology 20(5):1248–1259.
CDC (Centers for Disease Control and Prevention). 2011. Vital signs: Colorectal cancer screening, incidence, and mortality—United States, 2002–2010. Morbidity and Mortality Weekly Report 60(26):884–889.
CMS (Centers for Medicare & Medicaid Services). 2005. Demonstration of improved quality of care for cancer patients undergoing chemotherapy. Baltimore, MD: Centers for Medicare & Medicaid Services.
Cochrane, A. L. 1972. Effectiveness and efficiency: Random reflections on health services. London: Nuffield Provincial Hospitals Trust.
Edelman, M. J., D. Watson, X. Wang, C. Morrison, R. A. Kratzke, S. Jewell, L. Hodgson, A. M. Mauer, A. Gajra, G. A. Masters, M. Bedor, E. E. Vokes, and M. J. Green. 2008. Eicosanoid modulation in advanced lung cancer: Cyclooxygenase-2 expression is a positive predictive factor for celecoxib + chemotherapy—Cancer and Leukemia Group B trial 30203. Journal of Clinical Oncology 26(6):848–855.
Elkin, E. B., D. A. Marshall, N. A. Kulin, I. L. Ferrusi, M. J. Hassett, U. Ladabaum, and K. A. Phillips. 2011. Economic evaluation of targeted cancer interventions: Critical review and recommendations. Genetics in Medicine 13(10):853–860.
Ferreira-Gonzalez, A., S. Teutsch, M. S. Williams, S. M. Au, K. T. Fitzgerald, P. S. Miller, and C. Fomous. 2008. U.S. system of oversight for genetic testing: A report from the Secretary’s Advisory Committee on Genetics, Health and Society. Personalized Medicine 5(5):521–528.
Freidlin, B., L. M. McShane, and E. L. Korn. 2010. Randomized clinical trials with biomarkers: Design issues. Journal of the National Cancer Institute 102(3):152–160.
Goff, B. A., J. W. Miller, B. Matthews, K. F. Trivers, C. H. Andrilla, D. M. Lishner, and L. M. Baldwin. 2011. Involvement of gynecologic oncologists in the treatment of patients with a suspicious ovarian mass. Obstetrics and Gynecology 118(4):854–862.
Harris, L., H. Fritsche, R. Mennel, L. Norton, P. Ravdin, S. Taube, M. R. Somerfield, D. F. Hayes, J. R. C. Bast, and American Society of Clinical Oncology. 2007. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. Journal of Clinical Oncology 25(33):5287–5312.
Hayes, D. F., A. D. Thor, L. G. Dressler, D. Weaver, S. Edgerton, D. Cowan, G. Broadwater, L. J. Goldstein, S. Martino, J. N. Ingle, I. C. Henderson, L. Norton, E. P. Winer, C. A. Hudis, M. J. Ellis, D. A. Berry, and Cancer and Leukemia Group B Investigators. 2007. HER2 and response to paclitaxel in node-positive breast cancer. New England Journal of Medicine 357(15):1496–1506.
Henderson, I. C., D. A. Berry, G. D. Demetri, C. T. Cirrincione, L. J. Goldstein, S. Martino, J. N. Ingle, M. R. Cooper, D. F. Hayes, K. H. Tkaczuk, G. Fleming, J. F. Holland, D. B. Duggan, J. T. Carpenter, E. Frei, 3rd, R. L. Schilsky, W. C. Wood, H. B. Muss, and L. Norton. 2003. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with nodepositive primary breast cancer. Journal of Clinical Oncology 21(6):976–983.
Howlader, N., A. M. Noone, M. Krapcho, N. Neyman, R. Aminou, S. F. Altekruse, C. L. Kosary, J. Ruhl, Z. Tatalovich, H. Cho, A. Mariotto, M. P. Eisner, D. R. Lewis, H. S. Chen, E. J. Feuer, and K. A. Cronin. 2012. SEER cancer statistics review, 1975–2009 (vintage 2009 populations). Bethesda, MD: National Cancer Institute.
Howlader, N., A. M. Noone, M. Krapcho, N. Neyman, S. F. Altekruse, C. L. Kosary, M. Yu, J. Ruhl, Z. Tatalovich, H. Cho, A. Mariotto, D. R. Lewis, H. S. Chen, E. J. Feuer, and K. A. Cronin (Eds.). 2013. SEER cancer statistics review, 1975–2010. Bethesda, MD: National Cancer Institute.
IOM (Institute of Medicine). 2009. Initial national priorities for comparative effectiveness research. Washington, DC: The National Academies Press.
IOM. 2011a. Generating evidence for genomic diagnostic test development: Workshop summary. Washington, DC: The National Academies Press.
IOM. 2011b. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press.
IOM. 2011c. Finding what works in health care: Standards for systematic reviews. Washington, DC: The National Academies Press.
IOM. 2012a. Genome-based diagnostics: Clarifying pathways to clinical use: Workshop summary. Washington, DC: The National Academies Press.
IOM. 2012b. Evolution of translational omics: Lessons learned and the path forward. Washington, DC: The National Academies Press.
IOM. 2012c. Genome-based therapeutics: Targeted drug discovery and development: Workshop summary. Washington, DC: The National Academies Press.
Jacobs, I., D. Oram, J. Fairbanks, J. Turner, C. Frost, and J. G. Grudzinskas. 1990. A risk of malignancy index incorporating CA 125, ultrasound and menopausal status for the accurate preoperative diagnosis of ovarian cancer. British Journal of Obstetrics and Gynaecology 97(10):922–929.
Ladabaum, U., G. Wang, J. Terdiman, A. Blanco, M. Kuppermann, C. R. Boland, J. Ford, E. Elkin, and K. A. Phillips. 2011. Strategies to identify the Lynch syndrome among patients with colorectal cancer: A cost-effectiveness analysis. Annals of Internal Medicine 155(2):69–79.
McShane, L. M., D. G. Altman, W. Sauerbrei, S. E. Taube, M. Gion, G. M. Clark. 2005. Reporting recommendations for tumor marker prognostic studies (REMARK). Nature Clinical Practice Urology 2(8):416–422.
Menon, U., A. Gentry-Maharaj, R. Hallett, A. Ryan, M. Burnell, A. Sharma, S. Lewis, S. Davies, S. Philpott, A. Lopes, K. Godfrey, D. Oram, J. Herod, K. Williamson, M. W. Seif, I. Scott, T. Mould, R. Woolas, J. Murdoch, S. Dobbs, N. N. Amso, S. Leeson, D. Cruickshank, A. McGuire, S. Campbell, L. Fallowfield, N. Singh, A. Dawnay, S. J. Skates, M. Parmar, and I. Jacobs. 2009. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: Results of the prevalence screen of the UK collaborative trial of ovarian cancer screening (UKCTOCS). Lancet Oncology 10(4):327–340.
Meyer, R. 2011. Contrasting explanatory and pragmatic randomized controlled trials in oncology. http://meetinglibrary.asco.org/sites/meetinglibrary.asco.org/files/Educational%20Book/PDF%20Files/2011/zds00111000072.pdf (accessed October 8, 2013).
Molinaro, A. M., R. Simon, and R. M. Pfeiffer. 2005. Prediction error estimation: A comparison of resampling methods. Bioinformatics 21(15):3301–3307.
Moore, R. G., S. MacLaughlan, and J. R. C. Bast. 2010. Current state of biomarker development for clinical application in epithelial ovarian cancer. Gynecologic Oncology 116(2):240–245.
Moore, R. G., M. C. Miller, P. Disilvestro, L. M. Landrum, W. Gajewski, J. J. Ball, and S. J. Skates. 2011a. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstetrics and Gynecology 118(2 Pt 1):280–288.
Moore, H. M., A. B. Kelly, S. D. Jewell, L. M. McShane, D. P. Clark, R. Greenspan, D. F. Hayes, P. Hainaut, P. Kim, E. A. Mansfield, O. Potapova, P. Riegman, Y. Rubinstein, E. Seijo, S. Somiari, P. Watson, H. U. Weier, C. Zhu, and J. Vaught. 2011b. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathology 119(2):92–101.
Muggia, F. M., P. S. Braly, M. F. Brady, G. Sutton, T. H. Niemann, S. L. Lentz, R. D. Alvarez, P. R. Kucera, and J. M. Small. 2000. Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: A gynecologic oncology group study. Journal of Clinical Oncology 18(1):106–115.
Neuss, M. N., C. E. Desch, K. K. McNiff, P. D. Eisenberg, D. H. Gesme, J. O. Jacobson, M. Jahanzeb, J. J. Padberg, J. M. Rainey, J. J. Guo, and J. V. Simone. 2005. A process for measuring the quality of cancer care: The quality oncology practice initiative. Journal of Clinical Oncology 23(25):6233–6239.
O’Connell, M. J., I. Lavery, G. Yothers, S. Paik, K. M. Clark-Langone, M. Lopatin, D. Watson, F. L. Baehner, S. Shak, J. Baker, J. W. Cowens, and N. Wolmark. 2010. Relationship between tumor gene expression and recurrence in four independent studies of patients with stage II/III colon cancer treated with surgery alone or surgery plus adjuvant fluorouracil plus leucovorin. Journal of Clinical Oncology 28(25):3937–3944.
Phillips, K. A. 2008. Closing the evidence gap in the use of emerging testing technologies in clinical practice. Journal of the American Medical Association 300(21):2542–2544.
PricewaterhouseCoopers. 2009. The new science of personalized medicine: Translating the promise into practice. http://www.pwc.com/us/en/healthcare/publications/personalizedmedicine.jhtml (accessed August 31, 2012).
Ramsey, S. D., D. Veenstra, S. R. Tunis, L. Garrison, J. J. Crowley, and L. H. Baker. 2011. How comparative effectiveness research can help advance “personalized medicine” in cancer treatment. Health Affairs 30(12):2259–2268.
Ramsey, S. D., W. E. Barlow, A. M. Gonzalez-Angulo, S. Tunis, L. Baker, J. Crowley, P. Deverka, D. Veenstra, and G. N. Hortobagyi. 2013. Integrating comparative effectiveness design elements and endpoints into a Phase III, randomized clinical trial (SWOG S1007) evaluating Oncotype DX-guided management for women with breast cancer involving lymph nodes. Contemporary Clinical Trials 34(1):1–9.
Russo, P., F. S. Mennini, P. D. Siviero, and G. Rasi. 2010. Time to market and patient access to new oncology products in Italy: A multistep pathway from European context to regional health care providers. Annals of Oncology 21(10):2081–2087.
Saltz, L. B., D. Niedzwiecki, D. Hollis, R. M. Goldberg, A. Hantel, J. P. Thomas, A. L. Fields, and R. J. Mayer. 2007. Rinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: Results of CALGB 89803. Journal of Clinical Oncology 25(23):3456–3461.
Scher, H. I., S. Halabi, I. Tannock, M. Morris, C. N. Sternberg, M. A. Carducci, M. A. Eisenberger, C. Higano, G. J. Bubley, R. Dreicer, D. Petrylak, P. Kantoff, E. Basch, W. K. Kelly, W. D. Figg, E. J. Small, T. M. Beer, G. Wilding, A. Martin, M. Hussain, and Prostate Cancer Clinical Trials Working Group. 2008. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. Journal of Clinical Oncology 26(7):1148–1159.
Simon, R. M., S. Paik, and D. F. Hayes. 2009. Use of archived specimens in evaluation of prognostic and predictive biomarkers. Journal of the National Cancer Institute 101(21): 1446–1452.
Skates, S. J. 2012. Ovarian cancer screening: Development of the risk of ovarian cancer algorithm (ROCA) and ROCA screening trials. International Journal of Gynecological Cancer 22(Suppl 1):S24–S26.
Smith, I. E. 2001. Efficacy and safety of herceptin in women with metastatic breast cancer: Results from pivotal clinical studies. Anticancer Drugs 12(Suppl 4):S3–S10.
Sparano, J. A., and L. J. Solin. 2010. Defining the clinical utility of gene expression assays in breast cancer: The intersection of science and art in clinical decision making. Journal of Clinical Oncology 28(10):1625–1627.
Subramanian, J., and R. Simon. 2010. Gene expression-based prognostic signatures in lung cancer: Ready for clinical use? Journal of the National Cancer Institute 102(7):464–474.
Teutsch, S. M., L. A. Bradley, G. E. Palomaki, J. E. Haddow, M. Piper, N. Calonge, W. D. Dotson, M. P. Douglas, A. O. Berg, and Evaluation of Genomic Applications in Practice and Prevention Working Group. 2009. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: Methods of the EGAPP working group. Genetics in Medicine 11(1):3–14.
Ueland, F. R., C. P. Desimone, L. G. Seamon, R. A. Miller, S. Goodrich, I. Podzielinski, L. Sokoll, A. Smith, J. R. van Nagell, Jr., and Z. Zhang. 2011. Effectiveness of a multivariate index assay in the preoperative assessment of ovarian tumors. Obstetrics and Gynecology 117(6):1289–1297.
USPSTF (U.S. Preventive Services Task Force). 2012. Screening for Prostate Cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine 157(2):120–134.
Vogel, V. G., J. P. Costantino, D. L. Wickerham, W. M. Cronin, R. S. Cecchini, J. N. Atkins, T. B. Bevers, L. Fehrenbacher, E. R. Pajon, Jr., J. L. Wade, 3rd, A. Robidoux, R. G. Margolese, J. James, S. M. Lippman, C. D. Runowicz, P. A. Ganz, S. E. Reis, W. McCaskill-Stevens, L. G. Ford, V. C. Jordan, N. Wolmark, and National Surgical Adjuvant Breast and Bowel Project. 2006. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: The NSABP study of tamoxifen and raloxifene (STAR) P-2 trial. Journal of the American Medical Association 295(23):2727–2741.
Wong, W. B., S. D. Ramsey, W. E. Barlow, L. P. Garrison, Jr., and D. L. Veenstra. 2012. The value of comparative effectiveness research: Projected return on investment of the RxPONDER trial (SWOG S1007). Contemporary Clinical Trials 33(6):1117–1123.
Woodcock, J. 2010. Assessing the clinical utility of diagnostics used in drug therapy. Clinical Pharmacology and Therapeutics 88(6):765–773.
