CenterWatch Monthly April 2009
Friday, April 10, 2009
Pfizer’s Enhanced Clinical Trial Design Saves $100 Million Annually
Late-phase failure is an industry wide problem. Pfizer’s initiative, Enhanced Clinical Trial Design (ECTD), uses established statistical modeling approaches in an innovative manner to better size clinical trials and to stop inefficient drugs earlier.
Pfizer is already seeing higher success rates in phase III. About 90% of its phase III programs were successful in 2006. Because of the drug development cycle times, however, it’s too early to see the full impact of ECTD on the success rate of phase III trials. To date, internal analysis shows ECTD has had a significant impact on cost and time in late-stage productivity.
Clinical Trial Industry Embraces Online Social Networking
Originally created as a way for teens to keep in touch, social networking platforms, such as Facebook, MySpace and LinkedIn, have exploded into the adult arena with an increasing number of professionals using them to reconnect, network and market themselves and their businesses.
The clinical trial industry has joined this trend, as more clinical trial service providers and associations are turning to social networking applications to spread their message, recruit patients and build their businesses.
EMEA’s New Pharmacovigilance Head Makes Immediate Impact
Dr. Peter Arlett was appointed head of the European Medicines Agency (EMEA) sector for pharmacovigilance and risk management just a few months ago, but he has wasted no time readying the agency to implement a string of big initiatives during a time of great change for the EMEA as a whole.
The European Commission’s strategy document “Safe, Innovative and Accessible Medicines: A Renewed Vision for the Pharmaceutical Sector” was on the agenda at a major joint The Organisation for Professionals in Regulatory Affairs-European Union Commission meeting at the end of February. Furthermore, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has stepped into the public arena with a call for decisive action on proposals for new pharmaceutical sector legislation, including revised rules on pharmacovigilance.
Eye On: Epilepsy/Seizure Disorders
Epilepsy is a neurological disease characterized by seizures, or fits, causing loss of consciousness and/or generalized or focal neurological symptoms and signs, such as convulsions, abnormal behaviors and emotions, and/or unusual sensations or movements.
Epilepsy is the third most common neurological disorder in the United States, affecting about 2.7 million adults, or nearly one in 100 people, according to the Epilepsy Foundation. Worldwide prevalence of epilepsy is 40 to 50 million.
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