CROs Usage Associated with Faster Drug Development Speed at Comparable Quality, According to Tufts Center for the Study of Drug Development.BOSTON -- Contract research organizations (CROs) provide substantial global capacity to drug developers and have become a critical contributor to clinical trial activity, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the results of a study released today by the Tufts Center for the Study of Drug Development. The study was based on an analysis of 83 new drug applications and biologic license applications submitted to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) between 2000 and 2005. The study found that drug sponsors who are more extensive users of CROs tend to complete projects faster, most notably during the study close-out period, while maintaining quality comparable to submissions involving minimal use of CROs. In addition, projects involving high CRO usage typically are submitted more than 30 days closer to the projected FDA submission date than low CRO usage projects. In 2004, the most recent year for which data are available, leading CROs managed nearly 23,000 Phase I-IV studies at 152,000 clinical sites worldwide. "The results of our study challenge the conventional notion that CROs are simply vendors providing capacity for a specific project," said Ken Getz, senior research fellow at Tufts CSDD CSDD Center for the Study of Drug Development (Tufts University) CSDD Celu Satiksmes Drošibas Direkcija (Latvian: Central Department of Traffic Safety) CSDD Computer Software Design Description and author of the study. "Clinical outsourcing (1) Contracting with outside consultants, software houses or service bureaus to perform systems analysis, programming and datacenter operations. Contrast with insourcing. See netsourcing, ASP, SSP and facilities management. offers a development speed advantage at comparable quality. And as the volume and scope of clinical research activity worldwide continues to grow, CROs increasingly are providing a workforce that is essential to the long-term Long-term Three or more years. In the context of accounting, more than 1 year. long-term 1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term. viability of the enterprise." The new study, summarized in the January/February Tufts CSDD Impact Report, is the first comprehensive quantitative analysis Quantitative Analysis A security analysis that uses financial information derived from company annual reports and income statements to evaluate an investment decision. Notes: of the overall impact of outsourcing on drug development performance and capacity. Tufts CSDD estimates that $5.5 billion, or 15%, of global drug development spending, excluding pass-through fees (e.g., central lab costs and investigator grants), went to contract clinical services in 2004. This compares to 12% in 2001. The Tufts CSDD analysis also found that: --Overall development spending by sponsors has grown 9% annually since 2001, while clinical development headcount growth has been flat. --Employment trends suggest that CROs are the primary mechanism utilized by sponsor companies to augment aug·ment v. aug·ment·ed, aug·ment·ing, aug·ments v.tr. 1. To make (something already developed or well under way) greater, as in size, extent, or quantity: rising global capacity needs and contain R&D costs. To conduct the study, Tufts CSDD completed 31 interviews with pharmaceutical and biotechnology companies Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. of varying sizes, gathered data from 16 sponsors companies, and surveyed 10 CRO companies. Development programs for which less than 40% of the total budget went to contract clinical services were defined as 'low usage' and those programs for which more than 60% of the total budget went to CRO services were defined as 'high usage.' The study was funded in part by an unrestricted grant from the Association of Clinical Research Organizations. About the Tufts Center for the Study of Drug Development The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University Tufts University, main campus at Medford, Mass.; coeducational; chartered 1852 by Universalists as a college for men. It became a university in 1955. Jackson College, formerly a coordinate undergraduate college for women, merged with the College of Liberal Arts in provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia sym·po·si·a n. A plural of symposium. , workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues. |
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