The CenterWatch Monthly, January 2012

Tuesday, January 3, 2012 11:06 AM

Site landscape shrinking, losing most active PIs

The investigative site landscape has become more unstable during the past five years as the number of veteran investigators, the backbone of clinical research in the U.S., has shrunk at a faster rate than other segments, according to a new CenterWatch analysis. The fraction of most active FDA-regulated PIs, those who complete more than two 1572 forms each year, has dropped from 29% to less than 23% during the past five years, while the average number of new studies begun by the 60 highest volume sites in the U.S. and Canada fell by 85% during that period. The analysis, which takes an in-depth look at data amassed in the FDA’s Bioresearch Monitoring Information System (BMIS) database, suggests experienced PIs are finding it difficult to stay in business. Increasingly complex protocols, flat study budgets, more... 

 

Social media has sponsors losing control of their message

As more clinical trial participants begin to chronicle their journeys via blogs and social media sites, drug sponsors and CROs are quaking in their boots. With blogging and tweeting and Facebooking about one’s personal experiences in ongoing clinical trials in real time, patients potentially can unblind themselves and share perceived bad reactions and adverse events with the world. The rise of social media and online patient advocacy has put sponsors between a rock and a hard place: they need to participate to reach their audience, but they fear the loss of control over their message...

 

Eye On UCB

UCB is a global biopharmaceutical company headquartered in Brussels, Belgium, marketing products in more than 40 countries. Revenue in 2010 was $4.3 billion, and the company has more than 8,500 employees and strategic partnerships with key pharmaceutical companies. Its mission is to help people suffering from severe central nervous system or immunological disorders lead normal, everyday lives…

 

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CWWeekly

May 14

Survey: Confusing rules governing pediatric trials add to bigger challenge of finding enough participants

Researchers: Current ethics don't cover phase IV, as trials produce biased marketing detached from science

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CWWeekly

May

Newer sites most optimistic about the future
Investigative sites of all sizes, from part-time physician-run sites to large dedicated research centers, report a rebound in operating conditions, according to a new CenterWatch analysis, yet sites from each subgroup indicate they have concerns…

Risk-based monitoring slow to catch on with industry
It's estimated that the cost of physically sending monitors to all investigative sites at regular intervals, a model the industry itself developed and has adhered to for about a decade, eats up one-third to one-half of…

Eye On Millennium
Millennium, The Takeda Oncology Company, discovers and develops novel treatments applying world-class recombinant technology to a wide variety of oncology disease targets…

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