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CenterWatch Monthly February 2009

Tuesday, February 3, 2009

Japan’s Global CT Push Boosts CROs, EDC

Japan is making changes at every level of drug development—government, site, patient and sponsor—to improve the ease with which it can be included in global drug development programs. While sponsor companies still have to deal with aspects where Japan and the West fundamentally differ, inclusion of Japan in their global development programs has increased dramatically.

Maine Transparency Guidance Issued

The state of Maine has issued a guidance that includes changes to the first law in the U.S. to mandate public reporting of clinical trial results. The guidance comes only six months after the state of Maine implemented the law.

CROs Continue to Expand Eastward

Clinical research is taking off in Central and Eastern Europe (CEE) as the region with the largest number of global clinical trial initiations outside North America and Western Europe. However, CEE has plenty of room to grow in large countries, such as Russia and Ukraine, whose enormous clinical research potential has just begun to be tapped. In addition, there are still CEE countries farther East—many of which are former Soviet Republics—that are just beginning to conduct clinical research.

Eye On: Bacterial Infections

Despite dramatic advances in understanding and curbing the spread of infectious agents, as well as improvements in preventive vaccines and antibiotic therapy, bacterial infections remain a   major source of morbidity and mortality. Pneumococcal disease, causing pneumonia, sepsis, meningitis, otitis media (middle ear infection) and other serious infectious illnesses, is the leading vaccine-preventable cause of death in children under five years old, according to the World Health Organization.

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