Biomedical research at universities produces a steady stream of promising new pharmaceuticals and medical procedures, and clinical trials are a critical step in assessing their efficacy and safety before taking them to market.

But the process and negotiations involved in getting those trials off the ground—especially for studies taking place at multiple sites simultaneously—can be daunting.

This week the University of Iowa—through the Division of Sponsored Programs (DSP) in the Office of the Vice President for Research and Economic Development—finalized an agreement with other National Institutes of Health Clinical and Translational Science Awards (CTSA) institutions to run a pilot project testing a new, standard Accelerated Clinical Trial Agreement (ACTA).

The project seeks to significantly simplify and accelerate the approval process for clinical trial contracts, with the goal of expediting the translation of research into effective treatments for everything from cancer to diabetes.

“Contract negotiations are a complex process and are often identified as a major barrier to efficient study initiation,” says UI Vice President for Research and Economic Development Dan Reed. “The goal of this initiative has been to develop an efficient contract for sponsor-initiated multi-site trials. This streamlined process will allow sites to participate in clinical trials earlier in the process without undue delays in contract negotiations.”

To lay the groundwork for the pilot project, the CTSA Master Contracts Working Group, made up of contract experts from about 25 CTSA institutions, collaborated with industry and the University Industry Demonstration Partnership (UIDP) to develop a standardized clinical trial agreement. Each participating institution and sponsor may, voluntarily, use the single agreement to reduce contract negotiations for industry-sponsored, multi-site studies, specifically for Phase 2b and Phase 3 clinical trials

Phase 2b trials are specifically designed to study a drug’s efficacy (how well it works at the prescribed doses). Phase 3 trials assess the effectiveness of a new intervention and its value in clinical practice.

This initiative is part of broader efforts by the UI Office of Research and Economic Development and Institute for Clinical and Translational Science to accelerate the transfer of biomedical discoveries into practice via partnerships with existing companies, licensing of discoveries and support for new startups.

UI officials will schedule meetings on campus soon to share details of the pilot project and answer questions. More information is available at CTSA website.