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CenterWatch Monthly November 2008
November 4, 2008
No Standard Policy for Conflicts of Interest
Many research organizations have taken actions to strengthen their policies for managing financial conflicts in recent years. Despite individual organizations’ efforts, there are no universally accepted standards for managing conflicts of interest in clinical research. Nor is there a model policy to aid institutions in the development of their own policies.
Medical Writing Takes Off in India
Medical writing is the latest niche CRO service to be a focus in India. India-based company Cactus Communications has opened an office in the U.S., positioning itself to become a player in Western markets. With an English-speaking, highly skilled workforce and an infrastructure that meets international standards, India can expect to see more niche CRO services outsourced there.
Pediatric Networks Coming Into Their Own
Two years after the European pediatric regulation went into effect, its mandate to create a European pediatric network of research. The need for dedicated pediatric networks is clear. About 20% of the EU population, or about 100 million, are less than 16 years old. Between 50% and 90% of pediatric medicines have not been tested and evaluated. Between 15% and 20% of rare diseases only affect children, and 55% affect both adults and children. A budget of 30 million euros has been dedicated to pediatric research funding for studies into off-patent medicinal products for the first two years of the program.
Eye On: Cardiovascular Diseases
Heart disease is now the number one cause of death among adult women as well as adult men in both the United States and Europe. Acute myocardial infarction (AMI), or heart attack, results from atherosclerotic blockage of the main arteries supplying the heart muscle. AMI is the leading cause of cardiovascular death in the developed world, with more than 2 million new cases each year in the United States, Western Europe and Japan.
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