It’s not every day that you find perfectly complementary visionaries who can successfully co-lead an initiative. But that is what the University of Wisconsin School of Medicine and Public Health and UW Health found in Elizabeth “Betsy” Nugent, MSPH, CCRP, and Nasia Safdar, MD, PhD ’09 (PG ’00, ’02), as they joined forces to play vital roles in the academic medical center’s clinical trials enterprise and established the Wisconsin Medicine Institute for Clinical Trials.
The two have traveled different paths — they grew up in different countries, earned different degrees and experienced different career trajectories — but they are united by a fascination and commitment to the power and importance of clinical trials in advancing medicine and public health.
After earning a master’s degree in public health from the University of Colorado Health Sciences Center, she helped lead management and innovation in clinical trials for the health care and research giant Kaiser Permanente in its Colorado region. She also is a certified clinical research professional, indicating excellence in the ethical conduct of clinical trials.
In September 2019, Nugent moved her career to the School of Medicine and Public Health and UW Health, where she is the inaugural director of clinical trials development and accreditation, chief clinical research officer and director of the Wisconsin Medicine Institute for Clinical Trials.
“I’m a roll-up-your-sleeves type of person who gets in there and figures out a situation and how to streamline it, and that captured the attention of the team when I interviewed here,” says Nugent. “I was very eager to get started, and I was a bit starstruck to be coming to the same place that houses scientists, such as Dr. Thomas Rockwell ‘Rock’ Mackie, who have inspired me.”
Nugent also is motivated by the innovations that clinical trials exhibit and their important role in pushing medical science forward. The opportunity to be able to see firsthand these incredible discoveries gets her out of bed each morning.
“When you think about it, every device, every medication, every vaccine and every treatment that’s on the market had to go through a clinical trial,” Nugent observes. “Being on the cutting edge of making people’s lives better is so exciting to me.”
Safdar’s route to becoming a physician-scientist included earning her medical degree from Aga Khan University Medical College and completing a psychiatry internship at Sir Ganga Ram Hospital, both in Pakistan. In 1997, she moved to Madison, Wisconsin, where she completed a residency in general medicine and fellowships in infectious diseases and women’s health at UW Health. Since then, she also has earned a master’s degree in population health sciences and a doctorate in clinical research at the School of Medicine and Public Health.
A professor in the UW Department of Medicine, Safdar has more than 15 years of experience working with clinical trials. In September 2021, she was named the inaugural associate dean for clinical trials at the School of Medicine and Public Health and the inaugural research director of the Wisconsin Medicine Institute for Clinical Trials. She directs investigator-initiated and multi-site research for the UW Institute for Clinical and Translational Research and is the chief of research at the William S. Middleton Memorial Veterans Hospital. As an internationally recognized expert in hospital-acquired infections, she has led multiple trials to explore whether novel interventions like fecal microbiota transplantation can be used to treat Clostridium difficile intestinal infections. Her seminal work includes discovering the role of multiple health system elements in contributing to the spread of Clostridium difficile infection.
“With a clinical trial, the idea is you have a gap that needs to be addressed so you design a very rigorous study to answer the specific question and improve patient care,” Safdar explains. “I’ve experienced what it takes to put together a clinical trial, and I want to help others navigate the process.”
The Wisconsin Medicine Institute for Clinical Trials focuses on expanding this type of research at UW–Madison, creating the optimum environment for investigator-initiated studies and industry partnerships. Industry partners, including many that have spun out of UW–Madison, often bring important treatments, drugs and devices to the table, Nugent says, emphasizing that building and maintaining these relationships is critical.
As the institute has begun to take shape, Safdar and Nugent have been using the philosophy “if you build it, they will come.” Nugent is building the clinical trials infrastructure by managing operations and making sure the organization has adequate training, facilities and equipment. And Safdar is engaging scientists to come forward with their ideas for clinical trials and ensuring that care teams stand ready to assist in administering the investigations.
“Our goal is to enhance patient outcomes by building a diverse portfolio of clinical trials that allows patients in our system and beyond to participate in those trials so they can access the benefits,” notes Safdar. “To do this, you must have an infrastructure that makes the work easier to do and have clinicians prepared to take it on.”
Clinical trials are a narrow sliver of clinical research, usually with the goal of getting approval from the U.S. Food and Drug Administration, Nugent says, adding that the school and UW Health are involved in all phases of clinical trials.
The process includes ever-increasing complexity and innovation. For instance, in integrated clinical trials, the investigation is a treatment option for patients. According to Safdar, the COVID-19 pandemic also increased the use of adaptive designs for trials, in which information is gathered on multiple interventions and data are analyzed in real time. As the data show some interventions are ineffective, they can be let go and the trial focus shifted to more promising treatment options.
“Clinical trials are changing,” Nugent says. “These powerful methodologies were not regularly used just 20 years ago.”
Many elements of clinical trials have become household names during the COVID-19 pandemic, as an anxious world watched the incredible progress on therapies and vaccines against the novel virus. The School of Medicine and Public Health and UW Health have been hubs for these trials, carrying out tests on convalescent plasma therapy, an antibody cocktail developed by Regeneron Pharmaceuticals, the COVID-19 vaccine produced by AstraZeneca and more. Nugent assisted in these trials, and Safdar led a study to determine whether a common oral and nasal antiseptic would help prevent COVID-19 infections in health care workers.
UW Health physicians also awaited results of clinical trials done by others throughout the world. The way results are disseminated has started to change, notes Safdar, who uses social media to hear from others about effective treatments as soon as possible.
“To quickly and efficiently identify potential treatments, the only answer was to turn to clinical trials,” Safdar explains. “The fact that many institutions, including ours, were able to do that in a very short time frame told us that it could be done. And that’s something we want to carry forward after the pandemic to other conditions and diseases that clinical trials need to address.”
Beyond COVID-19, trials in numerous areas have been taking place at the school and UW Health. Nugent says there are 1,315 open trials that span cancer, cardiovascular and lung diseases, Alzheimer’s disease and other diseases of aging, infectious disease, neurology, pediatrics and more.
She and Safdar are strongly committed to the most important part of clinical trials: the patients. They spend a lot of time speaking to individuals about their decision to enroll in a trial and to the broader community about the importance and power of clinical trials.
“We need patients to partner in clinical trials because that’s the only way to move medicine forward,” Nugent shares. “Fortunately, in the last several years, there has been a lot more transparency around clinical trials. We aim to discuss the science with patients, get them engaged, and hear their thoughts and perspectives. I often share with patients the personal experiences my family and I have had with clinical trials.”
Making patients part of the equation also helps researchers recruit a diverse set of participants for clinical trials, a factor that is incredibly important to the research outcome. Involvement by people from groups that have been traditionally underrepresented — such as Black and Latinx individuals, and those who identify as LGBTQ+ and non-binary — is necessary for successful clinical trials. A poor trial can result in medications and interventions that do not work for the broad population, Safdar explains.
“It’s critical to involve a diverse set of participants because you want the results of the trial to be applicable to all populations that can benefit from it,” she says. “Unless you have proper representation, it’s unlikely that the results will be particularly useful for those who weren’t part of it. We are actively working to remove barriers to access for clinical trials so we can ensure diversity.”
Safdar and Nugent also stress the value of making sure all health care providers understand and keep up with clinical trials. The School of Medicine and Public Health and UW Health have made some trials accessible across Wisconsin and beyond, so conversations with all patients are important when conventional treatments are not effective.
“Results of trials everywhere may change how you provide care for patients,” shares Safdar. “Keeping up with the field, particularly areas that are evolving quickly, will make you a better physician because you will know about the latest and greatest and how you can change your practice in response.”
Nugent and Safdar look forward to continuing to work together to further the success of clinical trials and make the process seamless at the school and UW Health, and for patients. Their co-leadership roles seek to break down hierarchies and foster the most collaborative environment possible.
“I’m very proud of the leadership team that we’ve brought together,” Nugent declares. “We are dedicated to good science, and we hold the same values. Nasia, the clinical trials leadership team and the investigators we work with are some of the most amazing leaders I could ever hope to collaborate with in clinical research.”