The Center for Clinical Research can help scientists navigate the mazes of clinical trials to make the experience easier and more efficient.
A young physician has a great idea to help patients. But where does he start? A basic researcher is ready to take her research to clinical trials, but she’s never written a protocol. What does she do? An experienced researcher is looking to take his findings to the next level. Where can he turn?
Researchers interested in clinical research can find guidance and support at the SIU School of Medicine’s Center for Clinical Research (www.siumed.edu/ccr), designed to promote and facilitate clinical and translational research. About two dozen SIU School of Medicine faculty and research staff members are working to help with any aspect of clinical research, from industry-sponsored clinical trials to investigator-initiated clinical studies. “The Center is fulfilling a key element of the School of Medicine’s Strategic Plan to streamline patient-oriented research,” says Dean and Provost J. Kevin Dorsey, M.D., Ph.D.
Undertaking a clinical trial is a formulaic but meticulous process. The Center serves as a central point of contact for researchers and sponsors to link to shared services.
The Center is organized into four units, each with a unique purpose. While the Administrative Core is focused on the business side of the Center, the Clinical Trials, Research Development and Statistics and Research Informatics Cores serve researchers in different ways. “The Center’s team is optimizing the existing resources to be more productive, efficient and accountable,” says Sandra Puczynski, Ph.D., professor and director of Clinical Research Development. The Center already supports numerous researchers and divisions at SIU, including surgery, pediatrics, OB/GYN and emergency medicine.
The Clinical Trials Core is headed by Joseph Milbrandt, Ph.D., research associate professor in the Department of Surgery, and provides support for industry-sponsored projects, regulation and coordination. This Core can assist researchers with all aspects of clinical trials, from contract negotiation through staff training and project management. The Research Development Core is headed by Wiley Jenkins, Ph.D., MPH, research assistant professor in the Department of Family and Community Medicine, and provides assistance with all aspects of clinical research development. This includes assisting in the design of studies, the writing and submission of grants for internal and external funding, and navigating IRB and privacy issues. Educational opportunities in clinical trial coordination, good clinical practice, clinical research, and biostatistics are in the works.
The Statistics and Research Informatics Core is headed by Professor Steve Verhulst, Ph.D., and consists of many of the staff and functions of the former Division of Statistics and Research Consulting. This section will continue to support the clinical, basic science, educational, and administrative statistical and research needs of faculty. New support functions will focus on research informatics, clinical trial design and analysis, and health outcomes research.
Experts at the Center are assisting in the unprecedented growth of translational research projects at the School. “Details such as private health information, IRB approval and navigating the regulatory requirements are things many basic scientists have never had to deal with,” notes Dr. Jenkins. Another burgeoning area of research is community-based research, which requires collaborations. The Center can help link researchers with one of the dozens of hospitals, community organizations and foundations, or other universities already affiliated with SIU School of Medicine.
Dr. Puczynski expects researchers to use the center in different ways. Some with no infrastructure in their department will be totally dependent on the Center, while others can rely on the Center for support with details such as contract execution or budget development. “We can offer expertise at any level,” says Dr. Puczynski, “assisting someone who has never done a clinical trial to someone taking research in a new direction.” Some of that expertise comes from the Center’s medical director, Dr. Khaled Saleh, M.D., MHCM professor and chair of the Division of Orthopedic Surgery, who has substantial clinical research experience.
“Many physicians have ideas but lack the skills and experience to formally write a competitive research proposal. That inexperience can hurt their chances of funding,” he notes. “The Center can help clinical departments meet their research targets,” says Dr. Jenkins. “Pulling people together with different expertise into one unit to work as a team is much more efficient and effective than working individually. Working together, we help make the research processes easier and more efficient.”
With a centralized team of experts, the Center for Clinical Research will help SIU researchers become even bigger winners in the research race.