J Natl Cancer Inst. 2010 Oct 13. [Epub ahead of print] Cancer Pharmacogenomics and Pharmacoepidemiology: Setting a Research Agenda to Accelerate Translation.
Freedman AN, Sansbury LB, Figg WD, Potosky AL, Weiss Smith SR, Khoury MJ, Nelson SA, Weinshilboum RM, Ratain MJ, McLeod HL, Epstein RS, Ginsburg GS, Schilsky RL, Liu G, Flockhart DA, Ulrich CM, Davis RL, Lesko LJ, Zineh I, Randhawa G, Ambrosone CB, Relling MV, Rothman N, Xie H, Spitz MR, Ballard-Barbash R, Doroshow JH, Minasian LM.
Affiliations of authors: Division of Cancer Control and Population Sciences (ANF, LBS, SAN, RB-B), Medical Oncology Branch, Center for Cancer Research (WDF), Division of Cancer Epidemiology and Genetics (NR), Division of Cancer Treatment and Diagnosis (JHD), and Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM); Health Services Research, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC (ALP); Center for Drug Safety, University of Maryland School of Pharmacy, Baltimore, MD (SRWS); Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA (MJK); Division of Clinical Pharmacology, Mayo Clinic College of Medicine, Rochester, MN (RMW); Clinical Sciences, Cancer Research Center, University of Chicago Medical Center, Chicago, IL (MJR); UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, NC (HLM); Medco Health Solutions, Inc, Franklin Lakes, NJ (RSE); Center for Genomic Medicine, Duke Institute for Genome Sciences & Policy, Duke University, Durham, NC (GSG); Section of Hematology-Oncology, University of Chicago Medical Center, Chicago, IL (RLS); Ontario Cancer Institute, Princess Margaret Hospital, University of Toronto, Toronto, Ontario (GL); Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN (DAF); Division of Preventive Oncology, German Cancer Research Center and National Center for Tumor Diseases, Heidelberg, Germany (CMU); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (CMU); The Center for Health Research, Kaiser Permanente, Atlanta, GA (RLD); Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (LJL, IZ); Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD (GR); Department of Cancer Prevention and Control, Roswell Park Cancer Institute, Buffalo, NY (CBA); Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, TN (MVR); Division for Clinical Research Resources, National Center for Research Resources, National Institutes of Health, Bethesda, MD (HX); University of Texas M.D. Anderson Cancer Center, Houston, TX (MRS). Abstract
Recent advances in genomic research have demonstrated a substantial role for genomic factors in predicting response to cancer therapies. Researchers in the fields of cancer pharmacogenomics and pharmacoepidemiology seek to understand why individuals respond differently to drug therapy, in terms of both adverse effects and treatment efficacy. To identify research priorities as well as the resources and infrastructure needed to advance these fields, the National Cancer Institute (NCI) sponsored a workshop titled "Cancer Pharmacogenomics: Setting a Research Agenda to Accelerate Translation" on July 21, 2009, in Bethesda, MD. In this commentary, we summarize and discuss five science-based recommendations and four infrastructure-based recommendations that were identified as a result of discussions held during this workshop. Key recommendations include 1) supporting the routine collection of germline and tumor biospecimens in NCI-sponsored clinical trials and in some observational and population-based studies; 2) incorporating pharmacogenomic markers into clinical trials; 3) addressing the ethical, legal, social, and biospecimen- and data-sharing implications of pharmacogenomic and pharmacoepidemiologic research; and 4) establishing partnerships across NCI, with other federal agencies, and with industry. Together, these recommendations will facilitate the discovery and validation of clinical, sociodemographic, lifestyle, and genomic markers related to cancer treatment response and adverse events, and they will improve both the speed and efficiency by which new pharmacogenomic and pharmacoepidemiologic information is translated into clinical practice.
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