Affiliation: National Institutes of Health
- HIV-1 infected monozygotic twins: a tale of two outcomesLoubna Tazi
Division of Epidemiology, Human Genetics and Environmental Sciences, University of Texas, Health Science Center at Houston, School of Public Health, Brownsville, TX, USA
BMC Evol Biol 11:62. 2011..We explore the evolutionary processes and population dynamics that shape viral diversity of HIV in these monozygotic twins...
- Pediatric regulatory initiativesSteven Hirschfeld
National Children s Study Eunice Kennedy Shriver, National Institute of Child Health and Human Development, Bethesda, MD 20892, USA
Handb Exp Pharmacol 205:245-68. 2011....
- National Children's Study: update in 2010Steven Hirschfeld
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA
Mt Sinai J Med 78:119-25. 2011..Three different recruitment strategies are under evaluation to determine what approach to use for the Main Study. The organization of National Children's Study operations is currently based on a new decentralized business model...
- FDA drug approval summaries: oxaliplatinAmna Ibrahim
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
Oncologist 9:8-12. 2004..Approval was based on response rate and on an interim analysis of TTP. No results are available, at this time, that demonstrate a clinical benefit, such as improvement in disease-related symptoms or survival...
- The role of the fDA in cancer clinical trialsSteven Hirschfeld
Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Response, Food and Drug Administration Rockville, MD, USA
Cancer Treat Res 132:51-109. 2007
- Guiding the optimal translation of new cancer treatments from canine to human cancer patientsChand Khanna
School of Veterinary Medicine, University of Wisconsin Madison, Madison, Wisconsin, USA
Clin Cancer Res 15:5671-7. 2009..A summary of this meeting and subsequent discussion are provided here to afford clarity on the conduct of these studies so as to optimize the opportunities provided by this novel drug development and modeling strategy...
- Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group reportSteven Z Pavletic
National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892 1203, USA
Biol Blood Marrow Transplant 12:252-66. 2006..The proposed response criteria are based on current expert consensus opinion and are intended to improve consistency in the conduct and reporting of chronic GVHD trials, but their use remains to be demonstrated in practice...
- New models for large prospective studies: is there a better way?Teri A Manolio
Office of Population Genomics, National Human Genome Research Institute, Bethesda, Maryland, USA
Am J Epidemiol 175:859-66. 2012..Whether and how these approaches may be transportable to the United States remain to be explored, but their success in studies such as UK Biobank makes a compelling case for such explorations to begin...
- Regulatory approvals of pediatric oncology drugs: previous experience and new initiativesSteven Hirschfeld
Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
J Clin Oncol 21:1066-73. 2003..To review the Food and Drug Administration (FDA) experience with approvals of new drugs for pediatric oncology and to discuss new regulatory initiatives directed at pediatric oncology...
- The pediatric research equity act and oncologySteven Hirschfeld
Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 755, Rockville, MD 20852, USA
Pediatr Blood Cancer 43:99-102. 2004