COLUMBUS, Ohio – The Ohio State University has signed an agreement with seven other medical institutions across the state that will make it easier for researchers who are conducting clinical research to collaborate with each other. The agreement is also expected to make Ohio more attractive to industry looking for places to conduct clinical research – a growing source of job creation for the state.
Previously, each institution used its own Institutional Review Board (IRB), which reviewed proposals for conducting clinical research in humans to ensure that they followed ethics and safety guidelines. If a scientist wanted to collaborate with researchers at multiple institutions, in many cases a clinical research protocol had to undergo a separate review by each IRB.
This multiple review process can not only stall research, it can also stand in the way of scientists pursuing studies, said Karen Hale, RPh, MPH, CIP, director, Office of Responsible Research Practices at The Ohio State University and principal agreement developer.
“A researcher who wants to collaborate on a study that involves patients with rare diseases will have better success completing a trial and obtaining generalizable data by collaborating, but the potential delay caused by multiple reviews can have a negative effect,” said Hale. "By streamlining the number of IRB reviews multicenter studies undergo, the agreement will make it possible for studies to be approved at a much faster pace.”
Each of the institutions included in the agreement is affiliated with one of the three Clinical and Translational Science Awards (CTSA) sites in Ohio. The sites include The Ohio State University Center for Clinical and Translational Science (CCTS), University of Cincinnati Center for Clinical and Translational Science and Training and the Clinical & Translational Science Collaborative of Cleveland, based at Case Western Reserve University. The sites were established by the National Institutes of Health to accelerate the process of conducting clinical research and translating it into therapies that benefit human health.
“Today marks a historic step in fulfilling the CTSA’s mission of increasing collaboration among researchers and speeding scientific discovery to benefit patient treatment,” said Rebecca Jackson, M.D., director of the CCTS and associate dean of clinical research at The Ohio State University College of Medicine.
In 2008 alone clinical trials were responsible for supporting more than 84,000 jobs and spurring nearly $847 million in earnings in the state of Ohio. Experts believe opportunities provided by the agreement, including increased research collaboration and decreased review time, will incentivize investors to increase the number of studies conducted in Ohio.
“This agreement is integral in removing the layers of negotiation, IRB approvals and study updates sponsors faced in the past when facilitating multicenter studies,” said Clay Marsh, M.D., vice dean for research, The Ohio State University College of Medicine. “Not only does this agreement change the way medical research is conducted in Ohio, it’s also inspiring other fields of research to seek agreements that allow them to collaborate more closely, ultimately bringing us one step closer to our overall goal of creating a biotechnology research corridor.”
At the University level, Vice President for Research Caroline Whitacre, Ph.D. noted: “This unique agreement sets Ohio apart from most other states in that collaborative studies involving human subjects between health centers are now greatly facilitated.” In 2011, nearly 4,000 clinical trials were in progress in Ohio, ranking it seventh among states in the U.S. with the most clinical trials. “Under the terms of the new agreement, the number of trials conducted in Ohio is expected to increase, further fueling Ohio researchers’ ability to contribute to science,” said Whitacre.
The eight institutions included in the IRB agreement include The Ohio State University, Nationwide Children’s Hospital, Cincinnati Children’s Hospital Medical Center, University of Cincinnati, The MetroHealth System, University Hospitals Case Medical Center, Cleveland Clinic and Case Western Reserve University.
Recently, The Ohio State University and Cleveland Clinic announced a partnership to increase innovation and discovery by combining resources for researchers at both institutions. Charles Lockwood, M.D., dean of The Ohio State University College of Medicine is very supportive of this initiative and said the IRB agreement is just one of the examples of how this partnership is being implemented.
“By combining the efforts of these research powerhouses, along with the support of the CTSAs, we will make Ohio a premier place for biomedical research and discovery,” Lockwood said.
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About The Ohio State University Center for Clinical and Translational Science
Dedicated to turning the scientific discoveries of today into the life-changing health innovations of tomorrow, The Ohio State University Center for Clinical and Translational Science (OSU CCTS) is a collaboration of experts including scientists and clinicians from seven OSU Health Science Colleges, Ohio State’s Wexner Medical Center and Nationwide Children’s Hospital. Funded by a multi-year Clinical and Translational Science Award (CTSA) from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health, OSU CCTS provides financial, organizational and educational support to biomedical researchers as well as opportunities for community members to participate in credible and valuable research. The CCTS is led by Rebecca Jackson, M.D., Director of the CCTS and associate dean of research at The Ohio State College of Medicine. For more information, visit http://ccts.osu.edu.
About the Clinical and Translational Science Awards
Launched in 2006 by the NIH, and currently residing in the newly created National Center for the Advancement of Translational Sciences (NCATS), the Clinical and Translational Science Awards (CTSA) program created academic homes for clinical and translational science at research institutions across the country. The CTSA’s primary goals are to speed the time it takes for basic science to turn into useable therapeutics that directly improve human health, and to train the next generation of clinicians and translational researchers.