title: Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the critical pathway initiative.
abstract: Although there are rising public expectations about the prospects for new therapies based on advances in biomedical discoveries, the rate of new product submissions to the Food and Drug Administration (FDA) has not been increasing. Alarmingly, over the past 6 years, there has been a 30% decline in submissions. The reasons for this are multifactorial and include new science not at its full potential, mergers/business arrangements have decreased candidates, chronic disease is harder to study, the failure rate has not improved, and rapidly escalating costs and complexity. Notably, societal investment in research and development to improve the drug approval process has been lacking in contrast to the large investments, both private and public, in basic research and specific product advances. The Critical Path Initiative has been developed by the FDA to combat many of these issues. This initiative is designed to be collaborative between government, academic, industry, and patient groups. The partnership is designed to expand product opportunities by sharing existing knowledge and data, allowing the development of enabling standards, to improve drug development and approval. A central tenant of Critical Path is a focus on the evaluative science of the drug approval process, including both efficacy and safety measures. The FDA Electrocardiogram Warehouse is 1 example where a government resource could be used by a confluence of groups to improve the science surrounding important components of the drug approval process such as cardiac safety evaluation.
authors.affiliation: Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC 27715, USA. chris.cabell@duke.edu
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Cabell
authors.forename: Tory C
authors.initials: TC
authors.lastname: Noto
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D019091:Critical Pathways / Q000331:legislation & jurisprudence / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D004562:Electrocardiography / Q000592:standards*; D006801:Humans; D007883:Legislation, Medical / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration