There are many reasons for the design and conduct of clinical trials. The most recognizable objective of clinical trials is to collect and analyze data to demonstrate safety and efficacy to either gain or maintain regulatory approval for use. There are continual attempts to improve the drug development process by focusing on designing and conducting more fruitful trials that generate superior information on safety and/or efficacy in an ever increasing efficient manner. Such improvements are the logical focus of pharmaceutical industry particularly as technology advances and therapeutic areas of research evolve. Therefore, a better understanding of the costs, efficiencies, and barriers incurred during contemporary drug development process provides both insight and a rational benchmark for the stakeholders involved in various aspects of clinical trial processes. When equipped with these perspectives, clinical research stakeholders may be better equipped to identify opportunities for potential improvements and corrective actions to improve clinical research conduction.
Identify barriers and opportunities associated with clinical research of emerging drugs
Describe the business and financial aspects of contemporary drug discovery and development
Summarize the major therapeutic areas with active clinical investigation
BS, PharmD, MBA,
College of Pharmacy and Health Sciences, Campbell University