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

ents, or a therapy can only be tested in a small subgroup of patients with a specific genetic mutation. Competition for patients can slow the enrollment process and ultimately the time it takes to get results.

"Rather than two or three separate clinical trials competing for patients, things can get done faster by companies coming together and conducting a single trial," said Arthur J. Moss, M.D., a cardiologist at the Medical Center. "You can also use a single control group of patients, which cuts the number of participants needed and subsequently time and costs."

Another major advantage is the ability to directly compare several new therapies, or new versus old therapies, since they are all being tested in the same patient population, with the same set of rules, measuring the same set of outcomes.

"Treatment A may work compared to control in one trial, and treatment B may also work compared to control in another trial, but we wind up with no information on how to compare A and B," said Charles Francis, M.D., a professor in the Departments of Medicine and Pathology and Laboratory Medicine at the Medical Center.

"In the end, if we can come up with a more robust trial design that actually compares the effectiveness of different treatments, we are right in line with President Obama's healthcare initiative, which calls for providers and researchers to look at the things we're doing and study whether or not they are effective," added Ryan.

Today, large clinical trials are extremely expensive to carry out, as the FDA requires much better documentation, increasing quality control and longer follow-up periods than in the past. Many trials are international, spanning the U.S., Europe, Japan and other countries. The number of people needed to carry out an international trial involving thousands of patients for several years is a substantial cost in-and-of-itself.

Scientists have conducted studies with collaborative
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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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