Clinical Trials and its Role in the Research and Development of New Medicines
The Clinical Trials Business
The report provides an overview of clinical development phases, the regulatory issues involved, and the factors influencing clinical trial costs. An overview is provided of new technologies that will be affecting the clinical trial process in the near future. Major product pipelines are provided by physiological system and company.
Highlights
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.
In 2010, the number of clinical trials in the U.S. is 25,992. This number is expected to increase at a 5.7% compound annual growth rate (CAGR) to reach 32,318 in 2014.
Pharmaceutical and biotechnology companies devote a greater percentage of their budgets to R&D than does any other U.S. industry. In 2009, the pharmaceutical industry invested 34.8% of sales in domestic R&D. In 2014, this percentage is projected to increase to 48.8, a 7% compound annual growth rate (CAGR).
Scope
This report is designed to provide readers with a comprehensive understanding of the clinical trials process and its role in the research and development of new medicines in the U.S. It will provide an overview of clinical trials, including phases of clinical trials, U.S. government regulations, international regulations, costs of clinical trials, technologies, contract research organizations (CROs), and other factors. This report will forecast trends and clinical trial costs through 2014.
Generally, clinical trials are performed on drugs that have undergone a long test period. What are some of the factors that are and will bring drugs/devices as far as the clinical trial? What percentage of new chemical entities/proposals makes it to clinical trial? Who benefits from clinical trials, medically and financially? These areas will be reviewed and analyzed in this report.
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