Acronyms

ACS American Cancer Society

CLIA Clinical Laboratory Improvement Amendments

CMS Centers for Medicare & Medicaid Services

CT computed tomography

CTEP Cancer Therapy Evaluation Program

DCE dynamic contrast enhanced

EGF epidermal growth factor

ER estrogen receptor

FDA Food and Drug Administration

FDAMA Food and Drug Administration Modernization Act

FDG [18F]-2-fluoro-2-deoxy-D-glucose

FR Federal Register

GCRC General Clinical Research Center

HER-2 human epidermal growth factor receptor 2

IND investigational new drug



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OCR for page 107
Acronyms ACS American Cancer Society CLIA Clinical Laboratory Improvement Amendments CMS Centers for Medicare & Medicaid Services CT computed tomography CTEP Cancer Therapy Evaluation Program DCE dynamic contrast enhanced EGF epidermal growth factor ER estrogen receptor FDA Food and Drug Administration FDAMA Food and Drug Administration Modernization Act FDG [18F]-2-fluoro-2-deoxy-D-glucose FR Federal Register GCRC General Clinical Research Center HER-2 human epidermal growth factor receptor 2 IND investigational new drug 0

OCR for page 107
0 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS IRAT Image Response Assessment Team IRB Institutional Review Board LBNL Lawrence Berkeley National Laboratory MALDI matrix assisted laser desorption/ionization MedPAC Medicare Payment Advisory Commission MRI magnetic resonance imaging MSKCC Memorial Sloan-Kettering Cancer Center mTOR mammalian target of rapamycin NCCS National Coalition for Cancer Survivorship NCI National Cancer Institute NIH National Institutes of Health NSCLC non-small cell lung cancer PARP poly(ADP-ribose) polymerase PET positron emission tomography PhRMA Pharmaceutical Research and Manufacturers of America pre-IDE preinvestigation device exemption PSA prostate-specific antigen RECIST Response Evaluation Criteria in Solid Tumors SOP standard operating procedure SPA special protocol assessment SPECT single photon emission computed tomography SPORE Specialized Program of Research Excellence TBAC Tissue Banking Analysis Center TGen Translational Genomics Research Institute TNF tumor necrosis factor VEGF vascular endothelial growth factor