Investment in Phase 4 of Clinical Research is Expected to Top $12 Billion in 2007.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c49478) has announced the addition of Phase IV Clinical Trials Noun 1. phase IV clinical trial - sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier : Post-Marketing Study, Management Structure, Strategy & Benchmarks to their offering. Enhance Your Post-Marketing Trials: Phase 4 is the fastest-growing area of clinical research today. At an annual growth rate of 23%, industry investment in post-marketing research is expected to top $12 billion in 2007. Rampant growth in Phase 4 research should come as no surprise, however. A changing regulatory environment, growing concerns about the safety of new medicines, and various uses for large-scale, real-world data on marketed drugs' safety and efficacy are primary drivers of the growth seen in the Phase 4 research environment today. Post-marketing research is an important element of commercialization that enables companies to expand existing markets, enter new markets, develop and deliver messaging that directly compares their products with the competition, and secure a niche position in crowded markets. What's more, payer groups and regulators are both requiring more post-marketing data from drug companies. Given the increasing importance of post-marketing research, continued growth expected for Phase 4 trials, and mounting competitive pressures, it is critical for companies to make full use of the information and data available to them. Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy, and Benchmarks is a comprehensive post-marketing study management tool designed to provide industry executives with benchmark data and best practice information to inform key strategic and operational decisions in the areas of Phase 4: Trial management structure and oversight Research strategy Study design and execution Study timelines and cycle times Performance metrics Performance metrics are measures of an organizations activities and performance. Performance metrics should support a range of stakeholder needs from customers, shareholders to employees [1]. and management Operational activities Trial budgeting and outsourcing Trial staffing Metrics metrics Managed care A popular term for standards by which the quality of a product, service, or outcome of a particular form of Pt management is evaluated. See TQM. Included in the Report The list below covers the majority of the metrics included in Phase IV Clinical Trials, but it is not inclusive of inclusive of prep. Taking into consideration or account; including. all metrics contained in the report. Budget Metrics: Average per-patient clinical trial costs in the US (by therapeutic area) Percentage of clinical development budgets outsourced for US-based trials (by therapeutic area) Percentage of total R&D spending allocated to Phase 4 trials Staffing Metrics: Trial-specific staffing for 39 post-marketing trials covering more than a dozen therapeutic areas including trial size, location(s), product type, trial management approach, number of patients, and number of sites by the following clinical development functions and roles: VPs and therapeutic area supervisors trial managers CRAs/monitors data management medical writing biostatistics/bioanalytics regulatory clinical quality assurance clinical trial supplies CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. contract management drug safety Percentage of staff outsourced by product type (small molecules vs. biologics vs. medical devices) Patients-per-FTE by company size Patients-per-CRA ratios Performance Metrics: Phase 4 actual vs. projected trial durations/timelines Percentages of trial timelines consumed by various trial activities Percentage of surveyed companies that track various performance measures for: Cycle times and time-based trial milestones Resource allocation-based metrics (budgets and staffing) Efficiency and operations-based measures Surveyed companies' actual and target performance metrics for: Cycle times and time-based trial milestones Resource allocation-based metrics (budgets and staffing) Efficiency and operations-based measures Companies' self-assessments of their own performance measurement systems Other Metrics: Number of active Phase 4 studies by company Companies' self-assessments of the key motivating factors that drive them to conduct Phase 4 research Percentage of company-sponsored vs. investigator-sponsored post-marketing trials Percentage of NDAs with at least one post-marketing study commitment Percentage of products with post-marketing studies conducted (by company size) Companies' self-assessments of various opportunities for trial acceleration Total number of patients enrolled in Phase 4 studies, on average, by therapeutic area Total number of patients per site Percentage of companies that have internal infrastructures in place to conduct Phase 4 research in house Percentage of companies that outsource Phase 4 activities Breakdowns of departments that oversee strategy and operations for Phase 4 research Companies Mentioned - Amgen - Antibiotice - Biogen Idec Biogen Idec, Inc. (NASDAQ: BIIB) is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen and San Diego, California-based Idec - Boehringer Ingelheim - Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were - Clinical Conduct Associates - Elan (Emulated LAN) A virtual LAN in the ATM world. See LANE and virtual LAN. Elan - ["Top-down Programming with Elan", C.H.A. Koster, Ellis Horwood 1987]. Biopharmaceuticals - Endo Pharmaceuticals Endo became Endo Pharmaceuticals Inc. as a result of a management buyout from DuPont Merck in 1997. Endo is a specialty pharmaceutical company engaged in the research, development, sale and marketing of prescription pharmaceuticals used primarily to treat and manage pain. - Genentech - Genzyme - Ligand ligand (lĭg`ənd), charged or uncharged molecule with one or more unshared pairs of electrons that can attach to a central metallic atom or ion to form an aggregate known as a complex ion (see chemical bond). Pharmaceuticals - Merck & Co. - Millennium Pharmaceuticals Millennium Pharmaceuticals NASDAQ: MLNM is a biotechnology company based in the Cambridge, Massachusetts area of the United States of America. Founded in 1993, the company conducts research in various scientific areas, currently focusing on inflammation and oncology. - MJ Biopharm - Novo Nordisk Wikipedia is not the place for advertisement or self-advertising. Novo Nordisk (, NYSE: NVO) manufactures and markets pharmaceutical products and services. Founded in Denmark in 1923, the company has since become a world leader in diabetes care with the broadest - Ortho-McNeil Janssen - Ortho-McNeil Neurologics - Otsuka Pharmaceutical - PAREXEL - Pfizer - Schering-Plough - Serono - TEVA TEVA Tucson Electric Vehicle Association Neuroscience neu·ro·sci·ence n. Any of the sciences, such as neuroanatomy and neurobiology, that deal with the nervous system. neuroscience the embryology, anatomy, physiology, biochemistry and pharmacology of the nervous system. - Venturepharm Laboratories For more information visit http://www.researchandmarkets.com/reports/c49478 |
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