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Improving the Quality of Cancer Clinical Trials: Workshop Summary Encourage incorporation of biomarker tests early in drug development, even at the level of preclinical models. Devote greater efforts to establishing guidelines for the evaluation, standardization, validation, and qualification of biomarkers, especially those used in clinical decision-making. Develop a new funding mechanism to support the management of existing tissue repositories, and to support rational access to these valuable resources for testing biomarkers. Addressing some issues will require a great deal of work and research, Dr. Mendelsohn noted, but there was also some “low-hanging fruit” that could be accomplished in the near future as well. In particular, he noted that developing partnerships among Federal agencies like the NCI and the FDA in exploratory areas of research were likely to help move the field forward. REFERENCES Arias-Mendoza, F., M.R. Smith, and T.R. Brown. 2004. Predicting treatment response in non-Hodgkin’s lymphoma from the pretreatment tumor content of phosphoethanolamine plus phosphocholine. Acad Radiol 11(4):368-376. Berry, D.A. 2005. Statistical innovations in cancer research. In Cancer Medicine e.7: 411-425. London: BC Decker. Berry, D.A. 2006. Bayesian clinical trials. Nature Reviews Drug Discovery 5:27-36. Chin, K., S. DeVries, J. Fridlyand, P.T. Spellman, R. Roydasgupta, W.-L. Kuo, A. Lapuk, R.M. Neve, Z. Qian, T. Ryder, F. Chen, H. Feiler, T. Tokuyasu, C. Kingsley, S. Dairkee, Z. Meng, K. Chew, D. Pinkel, A. Jain, B.M. Ljung, L. Esserman, D.G. Albertson, F.M. Waldman, and J.W. Gray. 2006. Genomic and transcriptional aberrations linked to breast cancer pathophysiologies. Cancer Cell 10:529-541. Comis, R.L., J.D. Miller, C.R. Aldigé, L. Krebs, and E. Stoval. 2003. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 21(5):830-835. Dave, S.S., K. Fu, G.W. Wright, L.T. Lam, P. Kluin, E.J. Boerma, T.C. Greiner, D.D. Weisenburger, A. Rosenwald, G. Ott, H.K. Müller-Hermelink, R.D. Gascoyne, J. Delabie, L.M. Rimsza, R.M. Braziel, T.M. Grogan, E. Campo, E.S. Jaffe, B.J. Dave, W. Sanger, M. Bast, J.M. Vose, J.O. Armitage, J.M. Connors, E.B. Smeland, S. Kvaloy, H. Holte, R.I. Fisher, T.P. Miller, E. Montserrat, W.H. Wilson, M. Bahl, H. Zhao, L. Yang, J. Powell, R. Simon, W.C. Chan, L.M. Staudt, and Lymphoma/Leukemia Molecular Profiling Project. 2006. Molecular diagnosis of Burkitt’s lymphoma. N Engl J Med 354(23):2431-2442. Dehdashti, F., M.A. Mintun, J.S. Lewis, J. Bradley, R. Govindan, R. Laforest, M.J. Welch, and B.A. Siegel. 2003. In vivo assessment of tumor hypoxia in lung cancer with 60Cu-ATSM. Eur J Nucl Med Mol Imaging 30(6):844-850.
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Improving the Quality of Cancer Clinical Trials: Workshop Summary Rischin, D., R.J. Hicks, R. Fisher, D. Binns, J. Corry, S. Porceddu, and L.J. Peters. 2006. Prognostic significance of [18F]-misonidazole positron emission tomography-detected tumor hypoxia in patients with advanced head and neck cancer randomly assigned to chemoradiation with or without tirapazamine: A substudy of Trans-Tasman Radiation Oncology Group Study 98.02. J Clin Oncol 24(13):2098-2104. Schwartz, L.H., M. Mazumdar, L. Wang, A. Smith, S. Marion, D.M. Panicek, and R.J. Motzer. 2003. Response assessment classification in patients with advanced renal cell carcinoma treated on clinical trials. Cancer 98(8):1611-1619. Shukla-Dave, A., H. Hricak, M.W. Kattan, D. Pucar, K. Kuroiwa, H.N. Chen, J. Spector, J.A. Koutcher, K.L. Zakian, and P.T. Scardino. 2007. The utility of magnetic resonance imaging and spectroscopy for predicting insignificant prostate cancer: an initial analysis. BJU Int 99(4):786-793. Sjöblom, T., S. Jones, L.D. Wood, D.W. Parsons, J. Lin, T.D. Barber, D. Mandelker, R.J. Leary, J. Ptak, N. Silliman, S. Szabo, P. Buckhaults, C. Farrell, P. Meeh, S.D. Markowitz, J. Willis, D. Dawson, J.K. Willson, A.F. Gazdar, J. Hartigan, L. Wu, C. Liu, G. Parmigiani, B.H. Park, K.E. Bachman, N. Papadopoulos, B. Vogelstein, K.W. Kinzler, and V.E. Velculescu. 2006. The consensus coding sequences of human breast and colorectal cancers. Science 314(5797):268-274. Steward, W.P., A. Thomas, B. Morgan, B. Wiedenmann, C. Bartel, U. Vanhoefer, T. Trarbach, U. Junker, D. Laurent, and D. Lebwohl. 2004. Expanded phase I/II study of PTK787/ZK 222584 (PTK/ZK), a novel, oral angiogenesis inhibitor, in combination with FOLFOX-4 as first-line treatment for patients with metastatic colorectal cancer. J Clin Oncol, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition) 22(14S):3556. Taguchi, F., B. Solomon, V. Gregorc, H. Roder, R. Gray, K. Kasahara, M. Nishio, J. Brahmer, A. Spreafico, V. Ludovini, P.P. Massion, R. Dziadziuszko, J. Schiller, J. Grigorieva, M. Tsypin, S.W. Hunsucker, R. Caprioli, M.W. Duncan, F.R. Hirsch, P.A. Bunn, Jr., and D.P. Carbone. 2007. Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. J Natl Cancer Inst 99(11):838-846. Tomaszewski, J.E. 2004. Multi-species toxicology approaches for oncology drugs: The U.S. perspective. Eur J Cancer 40(6):907-913. Tsiatis, A.A. and C. Mehta. 2003. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 90(2):367-378. Tufts Center for the Study of Drug Development. 2007. Outlook 2007. http://csdd.tufts. edu/InfoServices/OutlookPDFs/Outlook2007.pdf (accessed Jan. 15, 2008). Von Hoff, D.D., R. Penny, S. Shack, E. Campbell, D. Taverna, M. Borad, D. Love, J. Trent, and M. Bittner. 2006. Frequency of potential therapeutic targets identified by immunohistochemistry (IHC) and DNA microarray (DMA) in tumors from patients who have progressed on multiple therapeutic agents. J Clin Oncol, 2006 ASCO Annual Meeting Proceedings Part I 24(18S):3071. Wiener, M.B., H.M. Newman, and E.A. Spradley. 2007. Revolutionizing oncology patient enrollment in clinical trials: Just-in-time approach. J Clin Oncol, 2007 ASCO Annual Meeting Proceedings Part I 25(18S):6577.
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Improving the Quality of Cancer Clinical Trials: Workshop Summary Yildiz, P.B., Y. Shyr, J.S. Rahman, N.R. Wardwell, L.J. Zimmerman, B. Shakhtour, W.H. Gray, S. Chen, M. Li, H. Roder, D.C. Liebler, W.L. Bigbee, J.M. Siegfried, J.L. Weissfeld, A.L. Gonzalez, M. Ninan, D.H. Johnson, D.P. Carbone, R.M. Caprioli, and P.P. Massion. 2007. Diagnostic accuracy of MALDI mass spectrometric analysis of unfractionated serum in lung cancer. J Thorac Oncol 2(10):893-901. Zhang, W., A.F. Purchio, K. Chen, J. Wu, L. Lu, R. Coffee, P.R. Contag, and D.B. West. 2003. A transgenic mouse model with a luciferase reporter for studying in vivo transcriptional regulation of the human CYP3A4 gene. Drug Metab Dispos 31(8):1054-1064.