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102 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS ⢠Encourage incorporation of biomarker tests early in drug develop- ment, even at the level of preclinical models. ⢠Devote greater efforts to establishing guidelines for the evaluation, standardization, validation, and qualification of biomarkers, espe- cially 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 âlow-hanging fruitâ 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- Hodgkinâs 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 Burkittâs 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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