CenterWatch Monthly June 2009

Friday, June 5, 2009 09:17 AM

U.S. Sites Rate Medpace, Kendle, ICON as Top CROs in 2009

Medpace, a private CRO on the rise, has been rated number one by U.S. investigative sites that it works with. Kendle, which came in second, has ranked in the top three in CenterWatch's survey the past three years, but was recently hit by a large number of project cancellations. Third place ICON returns to the top three for the first time since 2005.

Investigators were asked to rate the CROs that they have worked with during the past two years on a wide range of attributes and responsibilities. A total of 950  investigative sites completed the survey.

Pediatric Trials Move Toward Global Collaboration

As drug sponsors struggle to comply with new U.S and European regulations for pediatric studies, the FDA and EMEA have been working to coordinate global pediatric trials. Finding enough pediatric patients for these studies is a challenge and often requires multinational studies. Most pediatric trials are outsourced to CROs. As the studies go increasingly global, CROs with pediatric expertise and close relationships with sites that have experience with pediatric trials are expected to do well. Sites in the U.S. and the rest of the world that have proven themselves able to find pediatric patients and run efficient trials will be in demand.

European Biotech Sector Struggles to Survive Funding Crisis

One in five European small biopharmaceutical companies faces the risk of bankruptcy by the end of 2009. The situation could worsen if the economic downturn continues into 2010, warns the European Biopharmaceutical Enterprise (EBE), the trade group representing 63 companies in the European biotechnology sector. What is befalling the  biotech sector could have a ripple effect on the bottom lines of contract research organizations (CROs), especially those that cater mainly to the biotech sector.

"If we look at the medium-term future, we fear that approximately half of all of the European biotech small and medium enterprises [SMEs] are under threat. And this is something that is particularly concerning, not only specifically from a job loss perspective ... If we are going to lose small and medium enterprises and startups, we are going to lose innovation. That is the most important challenge," said Dr. Carlo Incerti, EBE president and head of European R&D at Genzyme.

Eye On: Arthritis

With longer life span and aging of the population in most developed countries, arthritis is on the rise, primarily due to joint wear and tear. Symptoms of arthritis include joint pain, aching, stiffness and limited range of motion. The most common form of arthritis and joint disease is osteoarthritis, with a worldwide prevalence of 5% of all adults, or about 20 to 30million people in the United States, according to the National Institutes of Health. More than three quarters of patients with osteoarthritis have some limitation of movement, and about one quarter is unable to perform activities of daily living.

Rheumatoid arthritis affects 0.8-1.0% of all populations, or about 1.3 million people in the United States. This form of systemic, progressive disease is caused by over activation of the immune system, resulting in widespread joint inflammation, typically involving the hands, wrists, and/or knees. The resultant soft tissue destruction and bone and cartilage erosion typically causes chronic pain and severe disability.


March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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