• Overall sponsor use of SMOs for clinical projects has risen by several percentage points. Larger average numbers of SMO sites are being used per clinical project.
• Usage growth has come despite mediocre SMO performance levels. Across a variety of factors, SMO performance ratings are typically on par with or lower than those of individual investigative sites and site networks, according to a new CenterWatch survey.

Article 218: Japanese Sponsors Drive Clinical Trials Growth

• The Japanese clinical trials industry is poised to play a growing role in global development projects. With mutual recognition of ICH-GCP guidelines, Japanese, U.S. and European sponsors can submit study data from their home country to regulatory authorities within the tripartite.
• Given weak domestic infrastructure, harmonization is stimulating the placement of Japanese-sponsored clinical trials among U.S. investigative sites. CROs in Japan face high demand, in part to help build study conduct infrastructure.

• For study coordinators and research professionals in Europe, the task of finding appropriate training programs may seem daunting. At present there is no accepted standard of certification across countries. However, many professionals recognize the need for furthering their education through courses and exams. Independent agencies and non-profits are getting into the training sector. Programs do exist, and the Internet can act as facilitator to bring these programs to the coordinator or investigator.

• There are many theories of what causes multiple sclerosis, but no firm answers for the chronic, progressive disease. This disease arises most in younger populations (between the ages of 20 and 40) from Western European backgrounds who live in the temperate areas of the world. In addition, women have a higher risk of developing MS than do men. CenterWatch Drug Intelligence has identified 12 multiple sclerosis drugs currently in the clinical development pipeline. We estimate that approximately $75 million will be spent on clinical research grants for this disease in 2001.