ABSTRACT
The development of new therapeutics for the treatment of insomnia involves the design and execution of clinical trials. Clinical trials are research studies involving human subjects that serve to characterize drugs under development; examine their safety, tolerability, and adverse effects in healthy subjects; and document their efficacy and safety in patient populations. Clinical trials are the most important and costly phase of the drug development process. According to industry reports, the pharmaceutical industry spent $44.5 billion on research and development (R&D) in 2007 (1) with clinical development costs representing approximately 60% of these expenditures (2). The data derived from the conduct of clinical trials are critical to the delivery of new therapeutics to the market. These data ultimately drive the drug development lifecycle and provide the basis of all new drug applications (NDAs) in the United States and other regulatory environments.
