A Jan. 31 open house highlighted services and resources of the Morsani Center’s expanded Clinical Research Center – for the benefit of faculty investigators and patients.

As USF Health’s overall research portfolio grows, the space, services and resources dedicated to clinical trials have also expanded.

Last fall, the Clinical Research Center (CRC), where USF Health faculty conduct clinical trials testing new ways to diagnose, treat and prevent human disease, moved from the first to the fourth floor of the Morsani Center for Advanced Healthcare.  The relocation and reconstruction nearly tripled the size of the center’s footprint to 4,500 square feet – a much-needed expansion since last year USF Health attracted a record $14.7 million in clinical trial revenue, up 133 percent over the last five years ($6.3 million in FY 2013-14).

USF Health leaders, faculty and staff will officially celebrate the launch of the new CRC on Jan. 31 with an open house for clinical investigators and staff, both those who currently use the center, and those faculty interested in finding out more about the space, technology and the on-site CRC team to support clinical trials.

USF Health neurologist Derrick Robertson, MD, a leading clinical investigator at the Morsani Center-based Clinical Research Center, speaks with a patient participating in a multiple sclerosis continuation drug trial.

The following are just some of the services and resources offered by the new and expanded CRC:

• Five examination rooms and six infusion rooms designed for patient comfort, with reclining chairs, televisions and computer work stations.
• A laboratory equipped to store, process and monitor specimens, and an area for secure investigational drug/product storage.
• Highly trained team of nurse managers, research nurses, study and regulatory coordinators to support study investigators.
• Open space equipped with computers, phones and other business amenities to accommodate faculty investigators and their departmental research staff.
• Support by the Office of Clinical Research to assist with business operations and/or financial services at all stages of non-federally sponsored clinical research studies.

Dr. Robertson reviews patient study-entry criteria with Carrie Downey (left), DO, a neurology fellow specializing in multiple sclerosis, and Angela Aungst, MPH, assistant director of MS clinical research.

USF Health has significantly upgraded its laboratories, equipment and other research infrastructure over the last several years – and clinical research growth continues to be a vital component of that investment.

Stephen Liggett, MD, associate vice president for research at USF Health and vice dean for research at the Morsani College of Medicine, attributes the growth to increased interest and training in clinical research by USF Health physicians as well as the dedication of administration and a top-notch team of CRC staff.

Faculty currently conduct 315 active trials — sponsored by industry, biopharma or foundations – testing new drugs, devices or other therapies for conditions ranging from Alzheimer’s disease and congestive heart failure to Parkinson’s disease, multiple sclerosis, and more.

Dr. Liggett expects clinical research activity to be even stronger in 2019.

“As an academic medical center, we are committed to understanding and solving the vexing clinical problems that elude us,” he said. “Rigorous clinical research encourages translational research, moving basic science discoveries in model systems to investigations focused on improving patient care and outcomes.”

USF Health neurologist Derrick Robertson, MD, one of the CRC’s top users, advocates for more faculty to take advantage of the center’s highly trained on-site support team and resources to conduct safe, controlled and compliant clinical trials.

Clinical research coordinator Brittany Harvey works in the new laboratory space at the Clinical Research Center.

Dr. Robertson, director of the USF Multiple Sclerosis Center, and his team participate in several trials testing new treatments for multiple sclerosis. He was the Tampa Bay region’s lead investigator for clinical studies of the intravenous medication ocrelizumab, which in 2017 became the first FDA-approved drug to slow progressive disability in a particularly aggressive form of multiple sclerosis called primary progressive MS.

“USF was one of the top-enrolling sites in the country, and our patients were part of the science that led to that game-changing drug getting approved.  The Clinical Research Center played a key role in facilitating that,” said Dr. Robertson, who continues ongoing studies of the MS drug, known commercially as Ocrevus.

In addition to the Morsani Center-based CRC, faculty lead clinical trials at Tampa General Hospital, the USF Health Neuroscience Institute (Byrd Alzheimer’s Institute and Center for Parkinson’s Disease and Movement Disorders), the South Tampa Center for Advanced Healthcare, the Hillsborough County Health Department, and the USF All Children’s Research Institute.

Ray Schneider (right), MS team research coordinator for the Department of Neurology, assesses the gait of a patient during a walk down one of the CRC hallways.

The volume of clinical trials at USF Health has climbed steadily over the last several years.

Stephen Liggett, MD, (right) associate vice president for research at USF Health, speaks with Charles Lockwood, MD, (center) senior vice president for USF Health and Morsani College of Medicine dean, and Kevin Sneed, PharmD, dean of the USF College of Pharmacy, during a tour of the new CRC space.

The CRC tripled in size and expanded resources with its recent relocation to remodeled space on the Morsani Center for Advanced Healthcare’s fourth floor.

-Photos by Torie M. Doll and graphics by Cynthia Greco, USF Health Communications and Marketing

National organization partners with USF Health, Moffitt and community advocates to broaden diversity

//www.youtube.com/watch?v=OaaOs-CYMAM

Story by Sandra Roa and Anne DeLotto Baier

Jumpstarting the critical work needed to broaden the genetic diversity of clinical trials was the focus when medical professionals and community leaders gathered in Tampa recently.

The safety and effectiveness of new drugs, vaccines, medical technology and other treatments will be optimized only when communities of color are adequately represented in the patient-oriented studies known as clinical trials, the group agreed.

Tampa community leaders met with USF Health and Moffitt researchers to discuss the need for increased minority participation in research trials.

“I have already seen it right here, in the Tampa Bay community, where we have people in the African-American community dying 10 years earlier than their Caucasian peers,”  said Kevin Sneed, PharmD, dean of the USF College of Pharmacy.

“We need a much broader spectrum of the population to make sure that a medication shown to be effective for one group is actually very effective for all the people who we intend to treat with that medication.”

Dr. Sneed was one of the panelists at the Tampa Bay region’s first Community Advocacy Matchmaking (CAM) luncheon and workshop held April 24.  The event was sponsored by 50 Hoops and the National Physician and Family Referral Project in partnership with USF Health and Moffitt Cancer Center.

The CAM group also will lay a foundation for the types of community education and local strategies that will help successfully increase minority enrollment in clinical research.

Kevin Sneed, PharmD, dean of the USF Colllege of Pharmacy, said increasing genetic diversity in clinical trials is critical for developing the most effective medications and other new treatments. He timed his talk with his iPhone.

Tackling the challenge of personalized medicine

Initiatives to include more minorities and women in clinical trials funded by the National Institutes of Health were mandated with the Revitalization Act of 1993. Yet, while African-Americans, Latinos, Asians and mixed sub-groups comprise almost 40 percent of the U.S. population, current clinical trial demographics do not reflect that same diversity.

In fact, non-whites still account for less than 5 percent of clinical trial participants. And while they bear a disproportionate share of several types of cancers, Latinos and Blacks have a participation rate of less than 2 percent in cancer clinical trials, according to a study published last year in the journal Cancer.

This narrow pool of DNA variants provides a very limited sample for researchers to study as they develop new treatments.

Ed and Patricia Sanders, founders of 50 Hoops, organize workshops nationwide to help communities increase minority recruitment into clinical trials.

Advances in molecular medicine are demonstrating that how a particular prescribed drug works for an individual patient, or subset of patients, is based in part on genetic variations within patient populations.  A significant portion of patients don’t have the same reaction to the same drug.  Yet, until recently drugs were typically prescribed with a “one size fits all” approach, resulting in trial and error until the optimal drug and dose is found.

The emerging field of pharmacogenomics – studying how an individual’s DNA influences his or her response to drugs — has begun to allow prescribers to individualize therapy.  This promises to decrease chances for adverse drug reactions, and improve health outcomes – if the genetic samples that researchers use when testing new medications are large enough to represent lots of variation in genetic patterns.

“We need our DNA in these trials. When my daughter or my grandson are on a surgery table and something is being administered to them, I want to know that at least 10 to 12 percent African-Americans have been tested,” said Patricia Sanders, director of the 50 Hoops/NPFR project.

Many medical professionals and community leaders registered to attend Tampa’s first Community Advocacy Matchmaking workshop.

Building trust with advocates in minority communities

Sanders works at the grassroots level connecting doctors, nurses and other clinical research professionals with community stakeholders to promote meaningful representation of African Americans, Hispanics/Latinos and other underrepresented populations in clinical trials.

At the Tampa CAM event, participants – including key leaders from local African American and Hispanic/Latino communities — discussed some of the barriers to clinical trial access and participation.  They touched on everything from lack of transportation, cultural factors and concerns over undocumented status to mistrust of doctors outside the community.

“One way to move towards a trusting community is to make sure that some of the researchers look like me,” said Walter Niles, MPA, manager of the Office of Health Equity at the Hillsborough County Health Department.  “Looking across the spectrum of the research team, (a potential clinical trial participant) ought to see some indications of diversity.”

Walter Niles, MPA, manager of the Office of Health Equity at the Hillsborough County Health Department spoke about ways to help increase racial and ethic diversity in patient-oriented studies.

The advocacy workshop emphasized the importance of building enduring relationships in communities so that people feel empowered to engage in studies that may lead to better treatments for cardiovascular disease, diabetes, certain cancers and other conditions that disproportionately affect minorities.

Connecting those underrepresented in clinical trials to the research critical to their health or the health of their descendants requires a dedicated, ongoing effort, Dr. Sneed said.

“We’ve begun the conversation,” he said. “As researchers interested in evidence-based care we must continue to answer questions with transparency, to build trust with advocates in the Tampa Bay community, and, hopefully, increase minority participation in clinical research.”

Each Community Advocacy Matchmaking workshop participant received resources needed to contact local community leaders and medical professionals to help with recruitment of minority communities.

Worshop participants discussed some of the barriers to clinical trial access and participation — everything from lack of transportation, cultural factors and concerns over undocumented status to mistrust of doctors outside the community.

Counterclockwise from far left: Pat and Ed Sanders, Hiram Green, Walter Niles, Chuck Wilson, Evangeline Best, Rosa Mckinzy Cambridge, and Amparo Nuñez were panelists at the Community Advocacy Matchmaking workshop.

Video by Sandra Roa and photos by Eric Younghans, USF Health Communications and Marketing

Studies investigate new treatment options for wide range of medical disorders

Tampa, FL (Oct. 4, 2012) — USF Health and EmergingMed have launched a University of South Florida Clinical Trials Matching Service that offers patients, caregivers and healthcare professionals a personalized, confidential matching and referral service for clinical studies at USF and other research affiliates across the Tampa Bay region.

The free navigation service can be accessed in English or Spanish, either by the Internet or by phone.  Its development was funded in part by a three-year federal Health Services and Resources Administration (HRSA) Telehealth Program grant, which supports the use of technology to deliver health care, information and education to the state’s rural and underserved populations.

The new USF database lists ongoing clinical trials for 40 medical conditions, including Alzheimer’s disease, asthma, depression, diabetes, Parkinson’s disease, and Tourette syndrome, to name a few.  Individuals can quickly search and determine initial eligibility for the clinical studies. With permission, the centralized call center’s Clinical Trial Navigators place follow-up calls to patients to address basic clinical trials questions and help assure connection with a clinical trial site.

While the trials currently listed are operated out of the Tampa Bay area – through USF Health, including hospital partners Tampa General Hospital and Moffitt Cancer Center — the service hopes to expand to encompass ongoing clinical research studies at other universities, hospitals and clinics across the state, said the project’s principal investigator Phillip Marty, PhD, associate vice president for research at USF Health.

“USF Health is committed to providing patients who are exploring treatment options access to the latest research opportunities targeting their specific diagnosis and treatment history,” Dr. Marty said.  “We want to create a common database platform that will increase the likelihood of Floridians finding clinical trials closer to home.”

USF Health’s Dr. Phillip Marty was principal investigator for the federal Health Services and Resources Administration (HRSA) Telehealth Program grant that helped support development of the clinical trials matching service.

Clinical trials are patient-oriented studies critical for advancing the prevention, detection or treatment of disease.  Their goal is to evaluate the safety and effectiveness of new tests, medications, surgical procedures and devices, or other treatments compared to existing standards of care.

Participants have the opportunity to help clinicians and researchers improve health and quality of life, while simultaneously receiving care that is as good as, or exceeds, standard care. Yet, only about 2 percent of Americans get involved with clinical trials research each year, according to the Center for Information and Study on Clinical Research Participation.

Karen Moffitt, PhD, a former USF educator, said USF’s Florida Clinical Trials Matching Service is modeled after FloridaCancerTrials.com. Moffitt was a founder of that now well-established statewide clinical trial service for patients diagnosed with cancer, along with former Florida Lt. Governor Frank Brogan and physician representatives from major cancer centers across Florida, including Moffitt Cancer Center. She was instrumental in conceiving the idea for the USF Clinical Trials Matching Service, and securing the funding needed to pilot the project.

The ultimate goal is to work toward a single, shared statewide clinical trials database for all diseases, not only cancer, which each institution could use to identify appropriate trials for patients in their communities, said Moffitt, lead author of a 2010 study that evaluated the Florida Cancer Trials network.

“More than 25 percent of all clinical trials open for enrollment in Florida are not listed in the federal database clinicaltrials.gov,” she said.  “We need to do a better job of providing up-to-date, accurate information and streamlining the enrollment process so that clinical trials are more accessible for patients and physicians.”

To access the online service, powered by EmergingMed, click here. To search by phone, call toll free (855) 731-6034.

-USF Health-

USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a global research university ranked 50^th in the nation by the National Science Foundation for both federal and total research expenditures among all U.S. universities.

Media contact:
Anne DeLotto Baier, USF Health Communications
(813) 974-3303 or abaier@health.usf.edu