• Use of call centers to recruit patients is growing at a faster rate due to heightened interest from CROs, dotcom companies and investigative sites.
• Investigative sites, networks and SMOs in particular may represent serious competition to stand-alone call centers lacking direct access to patients.

Article 210: The Choice for More Training

• Competition and new regulations are driving the clinical trial industry's need for more training and education.
• Study monitors, coordinators and even investigators will be investing significantly more time and dollars into training and education to improve GCP compliance and performance-related skills.

• Although several other European site management organizations have been considering ways to enter the U.S. market, Good Clinical Practice (GCP) is the only SMO to dip a toe into the water. However, the Rotterdam-based SMO is currently in the process of divesting itself of its American assets. The company had originally been attracted to the U.S. market because it was several years ahead. However, CEO and founder of GCP Dr. Henk Mulder said that the United States was too far away from the main office and is instead going to focus on expanding in Central and Eastern Europe.

• There are many causes of epilepsy, which affects more than two million Americans, including seizures resulting from congenital malformations, head injuries, brain tumors, aneurysms, metabolic problems, infections or for no apparent reason at all. Because of the number of people affected by epilepsy, this is a rapidly growing area of pharmaceutical R&D focus; sales of anti-convulsants in the United States approached $880 million last year. CenterWatch Drug Intelligence has identified 15 drugs that are currently in the clinical pipeline and estimates that between $185 million and $190 million will be spent on their development.