Clinical research is an essential component of Swedish Neuroscience Institute (SNI). It provides our patients therapeutic options that would otherwise be unavailable to them and places our staff at the forefront of medical knowledge as they evaluate leading-edge drugs and medical devices. The majority of SNI investigations assess the safety and efficacy of new drugs and devices. These studies are typically sponsored by the federal government, or pharmaceutical and medical device companies, with oversight provided by the U.S. Food and Drug Administration. Investigator-initiated trials at SNI answer questions about current standard-of-care therapies. These trials play an important role in supporting evidence-based medicine and advancing patient care.
Initiating a research study at SNI begins with a physician identifying a research question or a sponsor asking a physician to investigate a new therapy. After the physician defines the study protocol, he or she presents an overview to the SNI Research Committee to ensure sufficient patient access, financial support and staffing resources are available. After the committee has approved the protocol, the Swedish Institutional Review Board performs its federally-required review, which is designed to protect the welfare of research participants.
As research manager, I oversee the financial and regulatory aspects of clinical research at SNI, including budget, contract negotiations with study sponsors and the assignment of study coordinators to assist with IRB submissions and patient visits. This allows the investigator to focus on providing patient care, overseeing patient safety and collecting efficacy data.
Research at SNI currently includes 54 active investigations across nine programs, and is supported by more than $2 million dollars in annual funding. Thirty-seven of these studies are sponsored and financially supported by pharmaceutical and device companies, eight are investigator-initiated and nine are funded by the federal government or other non-profit organizations.
Research at SNI has a very bright future with many new and exciting trials on the horizon. The movement disorders program has ramped up its first clinical trial of a Parkinson’s disease treatment, and the Ivy Center for Advanced Brain Tumor Treatment is at the forefront of developing personalized medicine for brain cancer patients. One of the most exciting developments involves the bridging of two disciplines: deep brain stimulation (DBS) and psychiatry. The DBS program and the Swedish psychiatry program are evaluating clinical trials that use DBS for treatment resistant obsessive compulsive disorder and major depression. DBS offers hope for the most severely affected of these patients who continue to exhibit severe symptoms even after adequate trials of currently available therapies.
As a neuroscience center of excellence, SNI is uniquely designed to meet the healthcare challenges of the 21st century and beyond. We pursue evidence-based medicine by combining an academic focus on learning and research with high-quality clinical programs. The power to meet these challenges resides within each of us, and I encourage you to think about how you can be a pioneer in the advancement of medicine through clinical research.
If you would like to participate in clinical research activities at SNI, please contact:
Dan Rizzuto, Ph.D. | dan.rizzuto@swedish.org
