October 2000 – The CenterWatch Monthly : Volume 8, Issue 10, October 2000

Stirring Up the Phase I Market

Sponsors and CROs conduct the majority of phase I trials in facilities that they own and operate. However, a growing percentage of phase I trials are now being conducted among independent research centers.

The FDA has taken steps to streamline the IND process in order to address the large percentage of phase I trials initiated overseas. Combined with growing pipelines of drugs seeking entry 8into the large US market, an increasing proportion of total worldwide phase I trials will be initiated in the United States over the next several years.

AROs Add to Their Ranks

Harvard Clinical Research Institute is the first new entrant to provide hybrid project management and study conduct services on a scale and scope comparable to that offered by ARO market leader, Duke Clinical Research Institute.

AROs as a segment are finding a receptive market to their integrated services. At the same time, they are adhering to a unique philosophy that upholds the missions and objectives of their academic institutions.

CentreStage Europe: Developing a Global metaRegister of Trials

The global academic community, together with government-sponsored trial organizations from various countries, has begun to put its weight behind a global registry of clinical trials. Aided by recently passed laws mandating the registry of drug trials for serious and life-threatening conditions, the metaRegister - as it is called - has gathered steam enough to launch an international initiative. Nevertheless, the metaRegister may never achieve a complete record of all trials around the world without the support of pharmaceutical companies.

Eye On: Pediatrics: Recent Regulations Cause Boom in Research and Development

In the past century, the medical community has made tremendous progress in improving the health of children through pediatric clinical trials. Recently developed vaccines and approved drugs have significantly reduced the number of pediatric deaths. In 1997, Congress granted drug companies an additional six months of patent exclusivity if a company has successfully met the criteria established by the FDA for pediatric clinical trials. A recent survey conducted by PhRMA reported 217 medicines and vaccines currently in development for children. CenterWatch estimates that $850 million to $1.1 billion is currently being spent on pediatric clinical trials.

• Month in Review
• Opportunities Underway
• TrialWatch