|October 2001 (Volume 8, Issue 10)
Article 237: Quantifying Risk in Clinical Trials
- Investigative site personnel have little or no information about the general risks of participating in clinical trials. Yet communicating this information could positively influence patient recruitment.
- A recent CenterWatch analysis finds that the incidence of deaths during government- and industry-sponsored clinical trials is rare. One adverse event per study subject is typically reported on NDAs approved by FDA.
Article 238: A Market Receives EDC
Article 239: CentreStage Europe: The Groupe MAPI Builds DataBase of French Investigators
- Within two years, the market for EDC technologies has doubled to nearly $130 million. Sponsors are pushing EDC out of pilot usage and into their major clinical projects.
- Market leaders Phase Forward and CB Technologies are driving consolidation and joint venture activity in order to offer sponsors more integrated e-process solutions. Ultimately, these solutions will change that way that investigative sites, CROs and sponsors manage and conduct clinical trials.
Article 240: Eye On: Type I Diabetes
- As an alternative to and perhaps competition for site management organizations (SMOs), the Groupe MAPI, a holding company for organizations focused on pharmaceutical development, has begun to amass a database of French investigators interested in conducting clinical trials. With a goal of 15,000 investigators in the next three years, CIGlob, as the database is called, currently lists nearly 5,000 investigators after a year of effort.
- The World Health Organization estimates that approximately 150 million people worldwide have diabetes. According to the American Diabetes Association, some 16 million people with diabetes in the United States suffer with diabetes and another 5.4 million are not aware they have the disease. Diabetes is also a costly and deadly disease. Each year in the United States, diabetes accounts for nearly $100 billion in direct and indirect health care costs, and 193,000 deaths.