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Initiative speeds clinical trials contract negotiations

Nov. 5, 2015, 10:10 AM

An initiative promoted by the Vanderbilt Institute of Clinical and Translational Research (VICTR) offers an opportunity to reduce by more than half the time it takes to negotiate clinical trial contracts.

The goal is to quicken the pace of clinical trial start-up, to bring new drugs and treatments to patients more rapidly and potentially to cut the cost of clinical research.

The initiative was launched in 2012 by VICTR, which serves as coordinating center for institutions including Vanderbilt that have received Clinical and Translational Science Awards (CTSAs) from the National Institutes of Health (NIH).

It followed a study of contract negotiations by 29 CTSA institutions co-authored by Libby Salberg, J.D., director of the Vanderbilt Office of Contracts Management.

The study, published in Clinical and Translational Science in 2013, found that the average period of contract negotiations could be cut from 55 to 22 days if a “master agreement” was used.

With support from the National Center for Advancing Translational Sciences, part of the NIH, the CTSA Contracts Working Group developed a standardized clinical trial agreement for participating institutions and sponsors. Called the Accelerated Clinical Trial Agreement, or ACTA, it avoids the need for contract negotiations for industry-sponsored, multi-center studies.

The group is comprised of legal experts from about 25 CTSA institutions, in collaboration with industry representatives and the University Industry Demonstration Partnership (UIDP).

“For two years we went through every single word that goes into a clinical trial agreement,” said Terri Edwards, associate director of the CTSA coordinating center at Vanderbilt. After that, “we really had a document we could support and which institutions and organizations could implement.”

Negotiation of conventional contracts typically starts with each party’s ideal language. “Both sides are usually far apart,” Salberg noted. In contrast, the ACTA contains terms each party has already accepted, she said.

Since February, when the ACTA was first rolled out, more than 50 organizations representing more than 250 research sites have signed on to the agreement, Edwards said.

By leveraging the ACTA, sponsors of new clinical trials now can obtain immediate agreement from all of those organizations.

The ACTA was developed with the support of NIH grant TR000123.

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