Cancer Proteomics pp 237-258 | Cite as
Regulatory Issues in the Co-Development of Oncology Drugs and Proteomic Tests: An Overview
Chapter
Summary
In this article, we review some relevant issues in cancer proteomic biomarker development and validation for targeted cancer therapeutics with emphasis on the importance of developing a clearly stated intended use and indication for use, establishing a reliable laboratory measurement, using robust clinical study designs with representative patient populations and effective controls, and addressing issues of biological validations and potential bias associated with predictive biomarker validation.
Keywords
Cancer proteomics target therapy validation regulationPreview
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References
- 1.Liu ET. Expression genomics and drug development: towards predictive pharmacology. Brief Funct Genomic Proteomic 2005 Feb;3(4):303–21.CrossRefGoogle Scholar
- 2.Lindsey MA. Target discovery. Nat Rev Drug Discov 2003 Oct;2(10):831–8.CrossRefGoogle Scholar
- 3.Chanda SK and Caldwell JS. Fulfilling the promise: drug discovery in the post-genomic era. Drug Discov Today 2003 Feb 15;8(4):168–74.CrossRefGoogle Scholar
- 4.Alaiya A, Al-Mohanna, and Linder S. Clinical cancer proteomics: promises and pitfalls. J Proteome Res 2005 Jul–Aug;4(4):1213–22.CrossRefGoogle Scholar
- 5.Walgren JL and Thompson DC. Application of proteomic technologies in the drug development process. Toxicol Lett 2004 Apr 1;149(1–3):377–85.CrossRefGoogle Scholar
- 6.Pritchard KI, Shepherd LE, O’Malley FP, Andrulis IL, Tu D, Bramwell VH, and Levine MN, for the National Cancer Institute of Canada Clinical Trials Group. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med 2006 May 18;354(20):2103–11.CrossRefGoogle Scholar
- 7.Feng Z, Prentice R, and Srivastava S. Research issues and strategies for genomic and proteomic biomarker discovery and validation: a statistical perspective. Pharmacogenomics 2004 Sep;5(6):709–19.CrossRefGoogle Scholar
- 8.Mehta T, Tanik M, and Allison DB. Towards sound epistemological foundations of statistical methods for high-dimensional biology. Nat Genet 2004 Sep;36(9):943–7.CrossRefGoogle Scholar
- 9.Hayes DF, Bast RC, Desch CE, Fritche H, Jr, Kemeny NE, Jessup M, Locker GY, Macdonald JS, Mennel RG, Norton L, Ravdin P, Taube S, and Winn RJ. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 1996 Oct 16;88(20):1456–66.CrossRefGoogle Scholar
- 10.McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM; Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005 Aug 17;97(16):1180–4.Google Scholar
- 11.Schrorohl AS, Holten-Andersen M, Sweep F, Schmitt M, Harbeck N, Foekens J, and Brunner N, on behalf of the European Organization for Research and Treatment of Cancer (EORTC) Receptor and Biomarker Group. Tumor markers: from laboratory to clinical utility. Mol Cell Proteomics 2003 Jun;2(6):378–87.Google Scholar
- 12.Deyo RA and Jarvik JJ. New diagnostic tests: breakthrough approaches or expensive add-ons? Ann Intern Med 2003 Dec 2;139(11):950–1.Google Scholar
- 13.Bossuyt PM, Reitsma JB, Bruns DE, et al, for the STARD group. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD Initiative. Clin Chem 2003;49:1–6.PubMedCrossRefGoogle Scholar
- 14.Schmitt M, Harbeck N, Daidone MG, Brunner N, Duffy MJ, Foekens JA, and Sweep FC. Identification, validation, and clinical implementation of tumor-associated biomarkers to improve therapy concepts, survival, and quality of life of cancer patients: tasks of the Receptor and Biomarker Group of the European Organization for Research and Treatment of Cancer. Int J Oncol 2004 Nov;25(5):1397–406.Google Scholar
- 15.Dervieux T, Meshkin B, and Neri B. Pharmacogenetic testing: proofs of principle and pharmacoeconomic implications. Mutat Res 2005 Jun 3;573(1–2):180–94.Google Scholar
- 16.Lindpaintner K. Pharmacogenetics and the future of medical practice. Br J Clin Pharmacol 2002 Aug;54(2):221–30.CrossRefGoogle Scholar
- 17.Sams-Dodd F. Target-based drug discovery: is something wrong? Drug Discov Today 2005 Jan 15;10(2):139–47.CrossRefGoogle Scholar
- 18.Vogelstein B and Kinzler KW. Cancer genes and the pathways they control. Nat Med 2004 Aug;10(8):789–99.CrossRefGoogle Scholar
- 19.Segal E, Friedman N, Koller D, and Regev A. A module map showing conditional activity of expression modules in cancer. Nat Genet 2004 Oct;36(10):1090–8. Epub 2004 Sep 26.CrossRefGoogle Scholar
- 20.Hackett JL and Gutmann S. Introduction to the Food and Drug Administration (FDA) regulatory process. J Proteome Res 2005 Jul–Aug;4(4):1110–3.CrossRefGoogle Scholar
- 21.Bast RC, Jr, Lilja H, Urban N, Rimm DL, Fritche H, Grey J, Veltri R, Klee G, Allen A, Kim N, Gutman S, Rubin MA, and Hruszkewycz A. Translational crossroads for biomarkers. Clin Cancer Res 2005 Sep 1;11(17):6103–8.Google Scholar
- 22.Gutman S. Regulatory issues in tumor marker development. Semin Oncol 2002 Jun;29(3):294–300.CrossRefGoogle Scholar
- 23.Katz R. FDA: evidentiary standards for drug development and approval. NeuroRx 2004 Jul;1(3):307–16.CrossRefGoogle Scholar
- 24.Katz R. Biomarkers and surrogate markers: an FDA perspective. NeuroRx 2004 Apr;1(2):189–95.CrossRefGoogle Scholar
- 25.Harper CC, Phillip R, Robinowitz M, and Gutman SI. FDA perspectives on pharmacogenetic testing. Expert Rev Mol Diagn 2005 Sep;5(5):643–8.Google Scholar
- 26.Hirschfeld S and Pazdur R. Oncology drug development: United States Food and Drug Administration perspective. Crit Rev Oncol Hematol 2002 May;42(2):137–43.CrossRefGoogle Scholar
- 27.Hammond ME and Taube SE. Issues and barriers to development of clinically useful tumor markers: a development pathway proposal. Semin Oncol 2002 Jun;29(3):213–21.CrossRefGoogle Scholar
- 28.Rebbeck TR. Inherited genetic markers and cancer outcomes: personalized medicine in the postgenomic era. J Clin Oncol 2006, May1; 24(13):1972–4.CrossRefGoogle Scholar
- 29.Piccart-Gebhart MJ. Anthracyclines and the tailoring of treatment for early breast cancer. N Engl J Med 2006 May 18;354(20):2177–9.CrossRefGoogle Scholar
- 30.Walker JV and Nitiss JL. DNA topoisomerase II as a target for cancer chemotherapy. Cancer Invest 2002;20(4):570–89.PubMedCrossRefGoogle Scholar
- 31.Nitiss JL and Beck WT. Antitopoisomerase drug action and resistance. Eur J Cancer 1996 Jun;32A(6):958–66.CrossRefGoogle Scholar
- 32.Knoop AS, Knudsen H, Balslev E, Rasmussen BB, Overgaard J, Nielsen KV, Schonau A, Gunnarsdottir K, Olsen KE, Mouridsen H, and Ejlertsen B. Retrospective analysis of topoisomerase IIa amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil: Danish Breast Cancer Cooperative Group. J Clin Oncol 2005 Oct 20;23(30):7483–90.CrossRefGoogle Scholar
- 33.Mueller R, Parkes RK, Andrulis I, and O’Malley FP. Amplification of the TOP2A gene does not predict high levels of topoisomerase II alpha protein in human breast tumor samples. Genes Chromosomes Cancer 2004 Apr;39(4):288–97.CrossRefGoogle Scholar
- 34.Sandri MI, Isaacs RJ, Ongkeko WM, Harris AL, Hickson ID, Broggini M, and Vikhanskaya F. p53 regulates the minimal promoter of the human topoisomerase IIalpha gene. Nucleic Acids Res 1996 Nov 15;24(22):4464–70.CrossRefGoogle Scholar
- 35.Brandt TL, Fraser DJ, Leal S, Halandras PM, Kroll AR, and Kroll DJ. c-Myb trans-activates the human DNA topoisomerase IIalpha gene promoter. J Biol Chem 1997 Mar 7;272(10):6278–84.CrossRefGoogle Scholar
- 36.Ross JS, Fletcher JA, Bloom KJ, Linette GP, Stec J, Symmans WF, Pusztai L, and Hortobagyi GN. Targeted therapy in breast cancer: the HER-2/neu gene and protein. Mol Cell Proteomics 2004 Apr;3(4):379–98.CrossRefGoogle Scholar
- 37.Di Leo A, Gancberg D, Larsimont D, Tanner M, Jarvinen T, Rouas G, Dolci S, Leroy JY, Paesmans M, Isola J, and Piccart MJ. HER-2 amplification and topoisomerase IIalpha gene aberrations as predictive markers in node-positive breast cancer patients randomly treated either with an anthracycline-based therapy or with cyclophosphamide, methotrexate, and 5-fluorouracil. Clin Cancer Res 2002 May;8(5):1107–16.Google Scholar
- 38.Jarvinen TA and Liu E. HER-2/neu and topoisomerase IIalpha in breast cancer. Breast Cancer Res Treat 2003 Apr;78(3):299–311.CrossRefGoogle Scholar
- 39.Willis S, Hutchins AM, Hammet F, Ciciulla J, Soo WK, White D, van der Spek P, Henderson MA, Gish K, Venter DJ, and Armes JE. Detailed gene copy number and RNA expression analysis of the 17q12–23 region in primary breast cancers. Genes Chromosomes Cancer 2003 Apr;36(4):382–92.CrossRefGoogle Scholar
- 40.Chaurand P, Sanders ME, Jensen RA, and Caprioli RM. Proteomics in diagnostic pathology: profiling and imaging proteins directly in tissue sections. Am J Pathol 2004 Oct;165(4):1057–68.Google Scholar
- 41.Lindsey MA. Finding new drug targets in the 21st century. Drug Discov Today 2005 Dec;10(23–24):1683–7.CrossRefGoogle Scholar
- 42.Strohman R. Maneuvering in the complex path from genotype to phenotype. Science 2002 Apr 26;296(5568):701–3.CrossRefGoogle Scholar
- 43.Coggon D, Martyn C, Palmer KT, and Evanoff B. Assessing case definitions in the absence of a diagnostic gold standard. Int J Epidemiol 2005 Aug;34(4): 949–52.CrossRefGoogle Scholar
- 44.Colburn WA and Lee JW. Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling. Clin Pharmacokinet 2003;42(12):997–1022.PubMedCrossRefGoogle Scholar
- 45.Colburn WA. Biomarkers in drug discovery and development: from target identification through drug marketing. J Clin Pharmacol 2003 Apr;43(4):329–41.CrossRefGoogle Scholar
- 46.Frank R and Hargreaves R. Clinical biomarkers in drug discovery and development. Nat Rev Drug Discov 2003 Jul;2(7):566–80.CrossRefGoogle Scholar
- 47.Fishman MC and Porter JA. Pharmaceuticals: a new grammar for drug discovery. Nature 2005 Sep 22;437(7058):491–3.CrossRefGoogle Scholar
- 48.Wells KB. Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. Am J Psychiatry 1999 Jan;156(1):5–10.Google Scholar
- 49.Semmes OJ, Feng Z, Adam BL Banez LL, Bigbee WL, Campos D, Cazares LH, Chan DW, Grizzle WE, Izbicka E, Kagan J, Malik G, McLerran D, Moul JW, Partin A, Prasanna P, Rosenweig J, Sokoll LJ, Srivastava S, Srivastava S, Thompson I, Welch MJ, White N, Winget M, Yasui Y, Zhang Z, and Zhu L. Evaluation of serum protein profiling by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for the detection of prostate cancer: I. Assessment of platform reproducibility. Clin Chem 2005 Jan;51(1):102–12.Google Scholar
- 50.Kapp EA, Schutz F, Connolly LM, Chakel JA, Meza JE, Miller CA, Fenyo D, Eng JK, Adkins JN, Omenn GS, and Simpson RJ. An evaluation, comparison, and accurate benchmarking of several publicly available MS/MS search algorithms: sensitivity and specificity analysis. Proteomics 2005 Aug;5(13):3475–90.Google Scholar
- 51.Omenn GS. Advancement of biomarker discovery and validation through the HUPO plasma proteome project. Dis Markers 2004;20(3):131–4.PubMedGoogle Scholar
- 52.White CN, Chan DW, and Zhang Z. Bioinformatics strategies for proteomic profiling. Clin Biochem 2004 Jul;37(7):636–41.CrossRefGoogle Scholar
- 53.Villanueva J, Phillip J, Chaparro CA, Li Y, Toledo-Crow R, deNoyer L, Fleisher M, Robbins R, and Tempst P. Correcting common errors in identifying cancer-specific serum peptide signatures. J Proteome Res 2005 Jul–Aug;4(4):1060–72.CrossRefGoogle Scholar
- 54.Shin H and Markey MK. A machine learning perspective on the development of clinical decision support systems utilizing mass spectra of blood samples. J Biomed Inform 2006 Apr;39(2):227–48.CrossRefGoogle Scholar
- 55.Listgarten J and Emili A. Statistical and computational methods for comparative proteomic profiling using liquid chromatography-tandem mass spectrometry. Mol Cell Proteomics 2005 Apr;4(4):419–34.CrossRefGoogle Scholar
- 56.Lindon JC, Nicholson JK, Holmes E, et al, for The Standard Metabolic Reporting Structure Working Group. Summary recommendations for standardization and reporting of metabolic analyses. Nat Biotechnol 2005 Jul;23(7):833–8.CrossRefGoogle Scholar
- 57.Zhang Z and Chan DW. Cancer proteomics: in pursuit of “true” biomarker discovery. Cancer Epidemiol Biomarkers Prev 2005 Oct;14(10):2283–6.CrossRefGoogle Scholar
- 58.Simon R. Development and validation of therapeutically relevant multi-gene biomarker classifiers. J Natl Cancer Inst 2005 Jun 15;97(12):866–7.CrossRefGoogle Scholar
- 59.Simon R. Roadmap for developing and validating therapeutically relevant genomic classifiers. J Clin Oncol 2005 Oct 10;23(29):7332–41.CrossRefGoogle Scholar
- 60.Allison DB, Cui X, Page GP, and Sabripour M. Microarray data analysis: from disarray to consolidation and consensus. Nat Rev Genet 2006 Jan;7(1):55–65.CrossRefGoogle Scholar
- 61.Yasui Y, Pepe M, Thompson ML, Adam BL, Wright GL, Jr, Qu Y, Potter JD, Winget M, Thornquist M, and Feng Z. A data-analytic strategy for protein biomarker discovery: profiling of high-dimensional proteomic data for cancer detection. Biostatistics 2003 Jul;4(3):449–63.CrossRefGoogle Scholar
- 62.Tao WA and Asbersold R. Advances in quantitative proteomics via stable isotope tagging and mass spectrometry. Curr Opin Biotechnol 2003 Feb;14(1):110–8.CrossRefGoogle Scholar
- 63.Schlosser G, Pocsfalvi G, Huszar E, Malorni, and Hudecz F. MALDI-TOF mass spectrometry of a combinatorial peptide library: effect of matrix composition on signal suppression. J Mass Spectrom 2005 Dec;40(12):1590–4.CrossRefGoogle Scholar
- 64.Sun W, Wu S, Wang X, Zheng D, and Gao Y. An analysis of protein abundance suppression in data dependent liquid chromatography and tandem mass spectrometry with tryptic peptide mixtures of five known proteins. Eur J Mass Spectrom (Chichester, Eng) 2005;11(6):575–80.CrossRefGoogle Scholar
- 65.Wang W, Zhou H, Lin H, Roy S, Shaler TA, Hill LR, Norton S, Kumar P, Anderle M, and Becker CH. Quantification of proteins and metabolites by mass spectrometry without isotopic labeling or spiked standards. Anal Chem 2003 Sep 15;75(18):4818–26.CrossRefGoogle Scholar
- 66.Feng Z and Yasui Y. Statistical considerations in combining biomarkers for disease classification. Dis Markers 2004;20(2):45–51.PubMedGoogle Scholar
- 67.Zolg JW and Langen H. How industry is approaching the search for new diagnostic markers and biomarkers. Mol Cell Proteomics 2004 Apr;3(4):345–54.CrossRefGoogle Scholar
- 68.Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, Winget M, and Yasui Y. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst 2001 Jul 18;93(14):1054–61.CrossRefGoogle Scholar
- 69.Sledge GW, Jr. What is targeted therapy? J Clin Oncol 2005 Mar 10;23(8): 1614–5.CrossRefGoogle Scholar
- 70.Paik S. Clinical trial methods to discover and validate predictive markers for treatment response in cancer. Biotechnol Annu Rev 2003;9:259–67.PubMedGoogle Scholar
- 71.McShane LM, Altman DG, and Sauerbrei W. Identification of clinically useful cancer prognostic factors: what are we missing? J Natl Cancer Inst 2005 Jul 20;97(14):1023–5.Google Scholar
- 72.Conley BA and Taube SE. Prognostic and predictive markers in cancer. Dis Markers 2004;20(2):35–43.Google Scholar
- 73.Jansen AC, van Aalst-Cohen ES, Hutten BA, Buller HR, Kastelein JJ, and Prins MH. Guidelines were developed for data collection from medical records for use in retrospective analyses. J Clin Epidemiol 2005 Mar;58(3):269–74.CrossRefGoogle Scholar
- 74.Colantonio DA and Chan DW. The clinical application of proteomics. Clin Chim Acta 2005 Jul 24;357(2):151–8.CrossRefGoogle Scholar
- 75.Hu J, Coombes KR, Morris JS, and Baggerly KA. The importance of experimental design in proteomic mass spectrometry experiments: some cautionary tales. Brief Funct Genomic Proteomic 2005 Feb;3(4):322–31.CrossRefGoogle Scholar
- 76.Sargent DJ, Conley BA, Allegra C, and Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 2005 Mar 20;23(9):2020–7.CrossRefGoogle Scholar
- 77.American Society of clinical Oncology. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology. J Clin Oncol 1996 Feb;14(2):671–9.Google Scholar
- Hirschfeld S and Pazdur R. Oncology drug development: United States Food and Drug Administration perspective. Crit Rev Oncol Hematol 2002 May;42(2):137–43.CrossRefGoogle Scholar
- 79.Colburn WA. Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development. J Clin Pharmacol 2000 Dec;40(12 Pt 2):1419–27.Google Scholar
- 80.Floyd E and McShane TM. Development and use of biomarkers in oncology drug development. Toxicol Pathol 2004 Mar–Apr;32 Suppl 1:106–15.CrossRefGoogle Scholar
- 81.Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989 Apr;8(4):431–40.CrossRefGoogle Scholar
- 82.Fleming TR and DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996 Oct 1;125(7):605–13.Google Scholar
- 83.Buyse M and Molenberghs G. Criteria for the validation of surrogate endpoints in randomized experiments. Biometrics 1998 Sep;54(3):1014–29.CrossRefGoogle Scholar
- 84.Buyse M, Molenberghs G, Burzykowski T, Renard D, and Geys H. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics 2000 Mar;1(1):49–67.CrossRefGoogle Scholar
- 85.Burzykowski T, Molenberghs G, Buyse M, Geys H, and Renard D. Validation of surrogate endpoints in multiple randomized clinical trials with failure time end points. Appl Stat 2001 50:405–22.Google Scholar
- 86.DeGruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Firedman L, Gail M, Prentice R, Wittes J, and Zeger S. Consideration in the evaluation of surrogate endpoints in clinical trials: summary of a National Institutes of Health Workshop. Control Clin Trials 2001, 22:485–502.CrossRefGoogle Scholar
- 87.Xu J, Zeger SL. Joint analysis of longitudinal data comprising repeated measures and times to events. Appl Stat 2001 50:375–387.Google Scholar
- 88.Mayer D. Essential Evidence-Based Medicine. Cambridge University Press, UK, USA, Australia, Spain, South America; Bk&CD-Rom edition (June 17, 2004).Google Scholar
- 89.Fletcher RH and Fletcher SW. Clinical Epidemiology: The Essentials. Lippincott Williams & Wilkins, Philadelphia, Baltimore, New York, London, Buenos Aires Hong Kong, Sidney, Tokyo; 4th edition (March 2005)Google Scholar
- 90.Lesko LJ and Atkinson AJ, Jr. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol 2001;41:347–66.PubMedCrossRefGoogle Scholar
- 91.Gelmon KA, Eisenhauer EA, Harris AL, Ratain MJ, and Workman P. Anticancer agents targeting signaling molecules and cancer cell environment: challenges for drug development? J Natl Cancer Inst 1999 Aug 4;91(15):1281–7.CrossRefGoogle Scholar
- 92.Schilsky RL. End points in cancer clinical trials and the drug approval process. Clin Cancer Res 2002 Apr;8(4):935–8.Google Scholar
- 93.Williams G, Pazdur R, and Temple R. Assessing tumor-related signs and symptoms to support cancer drug approval. J Biopharm Stat 2004 Feb;14(1): 5–21.CrossRefGoogle Scholar
- 94.Fox E, Curt GA, Balis FM. Clinical trial design for target-based therapy. Oncologist 2002;7(5):401–9.PubMedCrossRefGoogle Scholar
- 95.Johnson JR, Williams G, and Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 2003 Apr 1;21(7):1404–11.CrossRefGoogle Scholar
- 96.Meyerson LJ, Wiens B, LaVange LM, and Koutsoukos AD. Quality control of oncology clinical trials. Hematol Oncol Clin North Am 2000 Aug;14(4):953–71, x.CrossRefGoogle Scholar
- 97.Cooper R and Kaanders JH. Biological surrogate end-points in cancer trials: potential uses, benefits and pitfalls. Eur J Cancer 2005 Jun;41(9):1261–6.CrossRefGoogle Scholar
- 98.Kelloff GJ and Sigman CC. New science-based endpoints to accelerate oncology drug development. Eur J Cancer 2005 Mar;41(4):491–501.CrossRefGoogle Scholar
- 99.Korn EL, Arbuck SG, Pluda JM, Simon R, Kaplan RS, and Christian MC. Clinical trial designs for cytostatic agents: are new approaches needed? J Clin Oncol 2001 Jan 1;19(1):265–72.Google Scholar
- 100.Park JW, Kerbel RS, Kelloff GJ, Barrett JC, Chabner BA, Parkinson DR, Peck J, Ruddon RW, Sigman CC, and Slamon DJ. Rationale for biomarkers and surrogate end points in mechanism-driven oncology drug development. Clin Cancer Res 2004 Jun 1;10(11):3885–96.CrossRefGoogle Scholar
- 101.Sargent D and Allegra C. Issues in clinical trial design for tumor marker studies. Semin Oncol 2002 Jun;29(3):222–30.CrossRefGoogle Scholar
- 102.Pajak TF, Clark GM, Sargent DJ, McShane LM, and Hammond ME. Statistical issues in tumor marker studies. Arch Pathol Lab Med 2000 Jul;124(7):1011–5.Google Scholar
- 103.Lagakos SW. The challenge of subgroup analyses-Reporting without distorting. N Engl J Med 2006 April 20, 354(16):1667–9.CrossRefGoogle Scholar
- 104.Westfall PH and Young SS. Resampling-Based Multiple Testing: Examples and Methods for p-Value Adjustment. Wiley Series in Probability and Statistics, New York, Canada (1993).Google Scholar
- 105.Ramnarayan P, Kapoor RR, Coren M, Nanduri V, Tomlinson AL, Taylor PM, Waytt JC, and Brotto JF. Measuring the impact of diagnostic decision support on the quality of clinical decision making: development of a reliable and valid composite score. J Am Med Inform Assoc 2003 Nov–Dec;10(6):563–72.CrossRefGoogle Scholar
- 106.Hwang D, Rust AG, Ramsey S, Smith JJ, Leslie DM, Weston AD, de Atauri P, Aitchison JD, Hood L, Siegel AF, and Bolouri H. A data integration methodology for systems biology. Proc Natl Acad Sci USA 2005 Nov 29;102(48):17296–301.CrossRefGoogle Scholar
- 107.Simon RM, Korn EL, McShane LM, Radmacher MD, Wright GW, and Zhao Y. Design and Analysis of DNA Microarray Investigations. Springer, New York (2003).Google Scholar
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