The Clinical Trials Summit: Working Together for Patients
Summary
- The University of Miami hosted the Clinical Trials Summit to foster the exchange of best practices among physician-scientists.
- The Clinical Trials Summit underscored the importance of working together to efficiently utilize and focus the University of Miami’s broad faculty capabilities.
- Clinical research continues to be a dynamic space, and a summit panel discussed blending technological innovation and ethical considerations while focusing on improving patient outcomes.
Clinical trials are central to the university’s research mission. More than 1,300 are currently in progress, most at the University of Miami Miller School of Medicine. The recent Clinical Trials Summit fostered the exchange of best practices amongst the physician-scientist attendees.
“We believe collaboration in research is key for awareness, efficiency, quality and compliance,” said Maria Alcaide, M.D., interim vice provost for research and scholarship at the University of Miami and professor in the Division of Infectious Diseases at the Miller School. “This event allows us all to find value in shared experiences as well as individual perspectives. These all contribute to greater protections with a participant-centric approach.”
Stephen D. Nimer, M.D., director of Sylvester Comprehensive Cancer Center and executive dean for research and professor of medicine, biochemistry and molecular biology at the Miller School, described the integral role of clinical trials in the patient experience.
“As the university enters a new century, we are going to be better than ever, with teamwork being the key to how we serve our participants and patients,” said Dr. Nimer, who is also the Oscar de la Renta Endowed Chair in Cancer Research. “They look to us for hope, excellence in medical care and to uphold the highest ethical standards in research.”
Setting the Standard in Clinical Research
UM currently oversees more than 5,000 active studies across a wide range of disciplines. The Clinical Trials Summit, presented in partnership with the Office of the Vice Provost for Research and Scholarship and the Office of the Executive Dean for Research at the Miller School, underscored the importance of working together to efficiently utilize and focus UM’s broad faculty capabilities.
“We are learning about why clinical trials are important, how we champion them through the various stages and compliance checkpoints we have in place,” said Guillermo “Willy” Prado, Ph.D., UM interim executive vice president and provost. “We are a collective community of special talents and natural curiosity. It is the sum of everything we do that helps see these clinical trials through from start to finish that impacts participant and patient lives.”
As the university celebrates its centennial, it now looks ahead to the next 100 years, with research a major component of its work and mission.
“The timing with our centennial is special because the university has evolved into this amazing academic enterprise, conducting research, education and service for South Florida and the nation,” said Alberto Caban-Martinez, D.O., Ph.D., M.P.H., professor and vice chair for research of public health sciences, deputy director of the M.D./M.P.H. program and associate vice provost for research regulation, integrity, security and evaluation at the Miller School. “Our event highlights the university’s commitment over the last 100 years to advance our research and service to many different community groups.”
FDA Best Practices
Experts from the U.S. Food and Drug Administration (FDA) began the presentation portion of the summit. Emily Baldwin, certified investigator specialist, identified applicable regulations and responsibilities for clinical/principal investigators conducting FDA-regulated studies. She explained the importance of training staff and organizing source documentation, while pinpointing additional best practices and procedures to protect subjects and enhance the reliability of collected data.
In a joint virtual discussion, Shiowjen Lee, Ph.D., deputy division director for the FDA, and Shari Messenger, Ph.D., professor in the Division of Biostatistics at the Miller School and director of the Biostatistics Collaboration and Consulting Core at UM, spoke on the role of statisticians in clinical trials and discussed expectations for successful collaboration.
“Biostatistics impacts the entire drugs/biologics development from phase one to post-marketing,” Dr. Lee said. “This is crucial in clinical trials for designing sound studies, ensuring trial integrity and drawing credible conclusions. A credible statistician ensures the approval of safe and efficacious biological products.”
Hot Topics in Clinical Research
Clinical research continues to be a dynamic space, blending technological innovation and ethical considerations while focusing on improving patient outcomes. A panel session explored these opportunities while addressing research challenges.
Sujatha Sridhar, M.B.B.S., M.C.E., associate vice president of research compliance at the University of Texas Health Science Center, focused on the lack of patient engagement in clinical trials.
“Studies are often delayed in meeting their recruitment goals 80 to 85% of the time,” Sridhar said. “Researchers can do their part by engaging more in the community for a better insight on what trials their desired participants want. They can also make it easier by reducing cost, having a user-friendly process and working with participants on new, incorporated technology.”
On the technology theme, Jennifer McCafferty-Fernandez, Ph.D., managing partner at Critical Path Advisors, LLC, advocated for equitable precision medicine and embracing technology to better prepare the workforce. Kenneth Goodman, Ph.D., professor of medicine at the Miller School and founder and director of the Institute for Bioethics and Health Policy at UM, further expanded on the topic.
“If you are not becoming familiar with technology, you are falling behind,” Dr. Goodman said. “Patients want more science, but to make progress, we must understand the tools we use and make sure we are using equitable practices with the right, patient-centered mindset.”
Clinical Trials at the U
The Clinical Trials at the U panel was led by:
• Philip Arlen, Ph.D., executive director for clinical research services at Sylvester
• Nicole McCullough, M.S., director of regulatory research support at the Miller School
• Laura Kozma, associate vice president for the Office of Research Administration at UM
• Leigh Nattkemper, Ph.D., assistant professor in the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery and director of clinical trials at the Miller School
• Karrelyn Gindy Wetherington, senior clinical trial disclosure associate in UM’s Office of the Vice Provost for Research and Scholarship
The speakers shared insights on how their respective departments manage clinical trials, with Dr. Arlen emphasizing Sylvester’s comprehensive approach to research.
“We’re proud of what we’ve built at Sylvester in its research enterprise,” Dr. Arlen said. “Our goal is to expand guidance and support across research protocols while maintaining high standards.”
The clinical trial path can be intricate. Kozma discussed UM’s feasibility review as a way the university supports nascent research.
“Clinical trials are complex, and we’re focused on highlighting both opportunities and challenges,” Kozma said. “The research feasibility process is a valuable tool. It helps us assess institutional capacity early on and streamline the path forward.”
In the latter stages of the process, the Office of Research Administration reviews Medicare coverage analysis and budget and clinical trial agreement, while the Institutional Review Board oversees protocols, participant-facing documents and advertising. The final step is site initiation and activation. The principal investigator ensures all study team members are trained and have the necessary supplies to conduct the trial.
“We are setting up our faculty to succeed as the summit brings them opportunities to network and invest in training resources,” said Kenia Viamonte, director of human subject research at UM. “When participants look to us for solutions, we want our brand to be of trust as their beacon of hope.”
Tags: clinical trials, Dr. Leigh Nattkemper, Dr. Maria Alcaide, Dr. Stephen Nimer, technology, University of Miami