Clinical and Translational Science Institute Brings Reduction in Clinical Research Center Fees
The Miami Clinical and Translational Science Institute (CTSI) is a newly formed institute which focuses on culturalized medicine and the advancement of health discoveries. This article is the first in a series that will highlight significant accomplishments, upcoming events and research services made possible by the CTSI.
The Clinical Research Center, which serves as a cornerstone of the clinical research infrastructure at the University of Miami, is now collaborating with the CTSI, further enhancing the clinical research services and resources offered to multidisciplinary investigators.
Located on the seventh floor of the Clinical Research Building, the outpatient facility features a comfortable, safe and effective environment to conduct professional, high-quality research involving human subjects in a wide variety of research areas, ranging from general medicine to specialized fields, including endocrinology, psychiatry and pulmonology. The center staff also delivers state-of-the art nursing, bionutrition, and laboratory services under a fee-for-service model that supports growth and investment in clinical and translational research.
As of January 1, the center is offering a service rate reduction for all protocols. Non-industry- and industry-sponsored studies will receive a rate subsidy of 75 and 35 percent, respectively.
Additionally, the center works with investigators and the Office of Research Administration to develop study budgets. NIH-supported and unfunded junior investigators performing novel, career-developing studies also can take advantage of the center’s subsidized services, which many principal investigators such as Rodolfo Alejandro, M.D., Director of the Clinical Cell Transplant Program at the Diabetes Research Institute, count as crucial.
“Our protocols are quite intense in regard to study visits, which include services provided at the CRC — phlebotomy, nutritional assessment and body composition measurements, EKG evaluation, glomerular filtration rate measurement and multiple days of metabolic testing,” said Alejandro, a professor of medicine. “The CRC plays a vital role in our ability to successfully complete protocol study visits in the rigorous nature required for research and assuring subject safety.”
Ihsan Salloum, M.D., M.P.H., professor of psychiatry and behavioral sciences and Chief of the Division of Substance and Alcohol Abuse, is principal investigator for several clinical trials to identify effective treatment for alcoholism and cocaine addiction in conjunction with bipolar disorder. He credits the CRC for enabling all study procedures to be conveniently completed in one location.
“We use the CRC as the clinical site for our studies, including initial and ongoing assessments and other study procedures, and to provide the psychotherapeutic interventions within each study,” he said. “Working with the current team of nurses under the direction of Joanne Krasnoff, the CRC operations manager, has been a real asset in terms of efficiency, attention to details, and team work.”
Similarly, Emmanuelle Simonet, M.A., CCRP, clinical research coordinator for Marilyn Glassberg, M.D., professor of medicine and surgery and principal investigator for the Interstitial Lung Disease Research Center, lauded CRC’s critical role in executing logistically complex studies.
“We have to manage more than 30 participants across eight active studies, some of them still enrolling, with various schedules and assessments required, with a staff of one and no permanent nurse coordinator,” Simonet said. “Now study visits are handled by the CRC, which provides a well-equipped space and adequate resources to conduct procedures in the most professional manner. Our study participants really appreciate the change and have adjusted quite easily.”
Olveen Carrasquillo, M.D., M.P.H., associate professor of medicine and Chief of the Division of General Internal Medicine, appreciates the center’s level of professionalism and efficiency. As principal investigator for the Miami Healthy Heart Initiative, an NIH-funded study that evaluates whether community health workers can help Latinos with poorly controlled diabetes lower other risk factors by addressing socioeconomic and lifestyle issues that affect health, Carrasquillo found the CRC’s support and assistance “streamlined the research protocol implementation process.”
“From the very beginning, the staff there has consistently provided us with a highly effective team of professionals who clearly have the experience and specific expertise necessary in clinical research involving diverse study populations,” he said. “The CRC provides the necessary components to optimize our research goals.”
Longtime faculty members like Alejandro also say the CRC, formerly known as the General Clinical Research Center, has long demonstrated the ability to achieve study compliance and progress and adjust to changes in the continually evolving field of clinical research.
“They have always shown an eagerness to adapt to study changes and new protocols and receive training in new procedures and testing when required to continue providing quality services at our request,” he said. “The CRC has been invaluable to our operation since 1985.”
The Clinical Research Center is supported by grant No. 1UL1TR000460, the University of Miami CTSI, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities.