New clinical trial agreements expedite contract negotiations

The adoption of standardized clinical trial and confidentiality agreements will help reduce the time it takes to get sponsored clinical studies up and running.

Stanford University has joined more than 200 academic institutions and hospitals in adopting standardized research and confidentiality agreements for use in industry-sponsored clinical trials.

The agreements have been pre-approved by participating institutions and organizations, and when used will expedite the process of starting a study.

Clinical research studies are essential to translate knowledge gained in the laboratory into interventions that improve human health. Multisite studies are critical because many diseases require large numbers of participants to yield valid findings. However, launching human studies at multiple institutions is complicated and can sometimes take months. There are many contributors to these delays, but a prime cause is the review and negotiation process for various agreements at each participating institution.

Data from a study that examined contracts processing for 2010 Clinical and Translational Science Awards revealed that an average contract negotiation time of 55 days, exclusive of budget and safety-board approvals, could be reduced to 22 days if a master agreement was used.

“Using these agreements will make it significantly faster for Stanford investigators to launch new clinical studies and easier for them to collaborate with peer institutions and industry,” said Harry Greenberg, MD, the medical school’s senior associate dean for research and the director of Spectrum, the Stanford Center for Clinical and Translational Research and Education.

Stanford representatives were part of the working group that developed the agreements over the last two-and-a-half years. The group also included representatives from the Clinical and Translational Science Awards consortium, industry and the University Industry Demonstration Partnership. The initiative was funded by the National Center for Advancing Translational Sciences within the National Institutes of Health.

To date, about 50 organizations representing more than 225 research sites have agreed to the terms of the agreements and accept them without revisions. Stanford’s Research Management Group is now using the clinical trial and confidentiality agreements when appropriate, and they plan on adopting a new agreement designed for use with outsourced contract research organizations after it is finalized by the working group in the next few weeks.

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2023 ISSUE 3

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