New government fund for academic centers to increase trial efficacy

Data

Two major academic medical centers have been given a 7-year, $26.5 million cash boost from the U.S. government to help weed out inefficiencies in clinical studies.

The federal grant has been handed out to researchers at Vanderbilt University Medical Center (VUMC) and Duke Clinical Research Institute (DCRI).

Danny Benjamin, faculty associate director of the DCRI, and Gordon Bernard, director of the Vanderbilt Institute for Clinical and Translational Research (VICTR), will be running the show.

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“The DCRI and Vanderbilt partnership is a perfect fit for the joint Trial Innovation Center,” said Benjamin in a university news release. “The academic research organization model at the DCRI and Vanderbilt’s informatics and central institutional review board model are poised to immediately contribute to the NIH’s vision of high-functioning networks for clinical research.”

Bernard added: “We are excited about the opportunity to be on the ground floor of building a new infrastructure for the efficient conduct of high-quality clinical research that has a major impact on human health."

With the money in place, the two centers will look at a number of ways of helping efficacy and speeding up trials.

One idea is to work with investigators to develop stronger protocols and achievable study budgets, while another is to set up “Master Clinical Trial Agreements” and oversee a central Institutional Review Board to get the trials underway as quickly as possible.

Over the years a slew of reports have shown that the inefficiencies in trials--such as having unnecessary endpoints and the expenses associated with collecting data for them--can add billions of dollars each year in extra expenses to the biopharma industry.

One of the latest reports, out from Tufts Center for the Study of Drug Development, found that pharma can be paying out as much as $6 billion extra a year as a result--but not necessarily producing better data.

Lowering costs while maintaining or even improving efficacy (and safety) is the Holy Grail for researchers and CROs.

- read the release

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