Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.

Publication Type:

Journal Article

Source:

Journal of the National Cancer Institute, Volume 102, Issue 22, p.1698-705 (2010)

Keywords:

2010, Animals, Antineoplastic Agents, Center-Authored Paper, Clinical Trials as Topic, Cooperative Behavior, Drug Approval, Drug Design, Genome-Wide Association Study, Humans, Individualized Medicine, Information Dissemination, Mutation, Neoplasms, Pharmacoepidemiology, Pharmacogenetics, Private Sector, Public Health Sciences Division, Public Sector, Retrospective Studies, Survivors, United States, United States Food and Drug Administration

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.