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To bring effective therapies to patients quicker, use the team approach
Date:3/3/2011

The current clinical trial process in the United States is on shaky ground. In this era of personalized medicine, as diseases are increasingly defined by specific genetic and biologic markers and treatments are tailored accordingly, patient populations for new therapies grow smaller and smaller. Coupled with skyrocketing costs and expanding regulatory requirements, the completion of trials that are essential in bringing new and effective therapies to patients is no easy task.

Change is needed.

Today, in the New England Journal of Medicine, a group of renowned researchers from around the world propose a new model to revitalize the research engine in this country collaborative clinical trials. They believe collaborative trials in which different companies team up and share the costs to test new therapies or devices will ensure safe and effective treatments become available more quickly and at a lower cost than they do today.

"The process of approving drugs for clinical use is progressively reaching an impasse in certain areas, and the problem will only be made worse with discoveries relating to personalized medicine, because there will be more drugs but smaller patient populations to test them in," said Daniel Ryan, M.D., chairman of the Department of Pathology and Laboratory Medicine at the University of Rochester Medical Center. "This is a way to restructure the system that will help us bring more good drugs forward for patient care."

A collaborative clinical trial could involve similar therapies from different companies, such as two drugs to lower blood pressure. Or, they could test a combination of different therapies from different companies, with each therapy designed to target a unique pathway or mechanisms involved in a more complex disease, like cancer.

There are many advantages to collaborative trials, including easier patient enrollment, especially when a disease affects a small number of pati
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Contact: Emily Boynton
emily_boynton@urmc.rochester.edu
585-273-1757
University of Rochester Medical Center
Source:Eurekalert

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