Clinical Trials: Strength in Numbers

Team approach is a win-win for researchers, patients.

By Gwen Fariss Newman, published in Capsule, Winter 2025
January 21, 2025

Faculty at the University of Maryland School of Pharmacy (UMSOP) engage, create, and pursue clinical trials to help improve the health, safety, and lives of people from Baltimore to communities around the world.

With an estimated 491,000 registered clinical studies underway globally, there is greater emphasis on more personalized medicine, greater inclusion of under-represented communities in clinical trials, and greater access to generative artificial intelligence (AI) and machine learning.

Paul Shapiro, PhD, is a professor in the Department of Pharmaceutical Sciences (PSC) at UMSOP and associate dean for research.

“UMSOP is committed to looking for new and safer drugs, and in moving drugs to the clinic more quickly, more effectively, and more efficiently,” he says. “With our broad range of expertise, our faculty, postdoctoral fellows, and students work to understand disease, evaluate current drugs from multiple viewpoints, and discover new drugs for evaluation in clinical trials.” But what exactly are clinical trials and why are they needed?

Perhaps you’re in enormous pain or can barely breathe and your medications aren’t working as effectively as you’d like or at all. Or perhaps you’re taking a medication that improves certain conditions such as depression, high blood pressure or diabetes, but has unwanted side effects, like dizziness, weight gain, or insomnia. Or you might suffer from a rare disease and not even the most acclaimed health care professionals have determined modes to cure or even relieve it.

It’s through clinical trials that the brightest minds come together to observe and learn more about specific disease states, identify first-time therapeutic solutions, finesse them, and flag potential problems with what initially appears to be a viable solution.

The National Institutes of Health defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions [which may include placebo or other control] to evaluate the effects of those interventions on health-related biomedical or b behavioral outcomes.” Investigators use the following questions to determine if their proposed study fits the clinical trial definition and to assess funding options:

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

At UMSOP, there are clinical trials — of all sorts — underway, all the time. The results are both current and, at times, historic.

Sunscreens and Hormone Replacement Therapy

Audra Stinchcomb, PhD, RPh, FAAPS, FAIMBE, is a professor in PSC and an expert in topical solutions applied directly to the skin.

Her research includes a recent clinical trial that looked at the safety of key ingredients in sunscreens. The findings led to a once-common ingredient (oxybenzone) being banned or limited after the trial showed the chemical, a known endocrine disruptor and potential breast cancer and endometriosis risk multiplier, was observed in higher blood levels than anticipated. There also are indications that this ingredient, and other similar UV blockers, can lower testosterone levels and impact the environment. The study was conducted with PhD students and postdoctoral fellows in
Stinchcomb’s lab and in partnership with faculty at the University of Maryland School of Medicine.

Stinchcomb currently is engaged in a hormone replacement therapy clinical trial for women, specifically investigating topical gels and pharmacy-compounded creams to minimize menopausal symptoms such as hot flashes, night sweats, cold chills, mood swings, and irritability.

Long-term objectives of Stinchcomb’s research include examining microneedles that create skin micropores invisible to the human eye but that transmit time-released treatment, and prodrugs — those that are inactive until metabolized inside the body — specifically designed for improved transdermal patch and microneedle-enhanced delivery. She also seeks to find methods to prolong the lifetime of drug delivery through transdermal device created micropores, and unique translational research models for efficient drug discovery and development.

Enhanced Drug Delivery and Potential New Uses

James Polli, PhD, a professor in PSC and the Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, focuses on the creation and improved administration of oral medications.

For oral medications to be most effective, they must first dissolve after being swallowed. Some do this more readily than others. Polli is exploring
ways to improve the formulation of tablets so they can dissolve more readily.

“Drugs with low solubility sometimes require the inert ingredients in tablets to help the drug dissolve after being swallowed,” he says. “This study uses itraconazole — a medication used to treat infections caused by fungus — as an example drug with low solubility. Itraconazole tablets with different inert ingredients and manufacturing will be administered to healthy volunteers to see if the different inert ingredients and manufacturing impact drug absorption.”

He also is exploring whether an investigational medicine authorized for emergency use to treat mild-to-moderate COVID-19 in adults at high risk of severe illness might have broader therapeutic potential.

Molnupiravir (MOV) was initially developed to treat the flu and is an antiviral therapy that inhibits replication of multiple RNA viruses, including SARS-CoV-2, the virus causing COVID-19. In December 2021, the U.S. Food and Drug Administration (FDA) issued emergency use authorization for the medication in high-risk COVID-19 patients. The question now is whether this treatment option has broader applicability and/or risks. The sample population will include patients treated with and without molnupiravir to determine if it causes DNA shifts or other variations.

The study is being conducted with error-corrected whole-genome high-fidelity sequencing methodology. “Such information may inform the ongoing evaluation of MOV as an antiviral therapy and expand our therapeutic options clinically,” Polli says. Both studies are collaborations with the FDA.

Improved Staffing Ratios in Critical Care Units – And Beyond

Mojdeh Heavner, PharmD ’08, BCCCP, FCCM, FCCP, an associate professor in the Department of Practice, Sciences, and Health Outcomes Research (P-SHOR), assistant dean for experiential learning, and a critical care pharmacist, studies the impact of pharmacists in clinical practice and improving outcomes through implementation of intensive care unit (ICU) programs to standardize and streamline care delivery. She notes that another number-crunching study also originated following the early days of the COVID-19 pandemic when ICUs were overwhelmed with patients, and health care providers were faced with staff burnouts and hiring shortages.

“We know the workload of health care professionals in the ICU has an established relationship to patient outcomes. However,” Heavner adds, “the relationship of critical care pharmacist workload to patient outcomes had not been rigorously evaluated nor determined. The objective of this study is to characterize the relationship of critical care pharmacist workload in the ICU as it relates to patient-centered outcomes of critically ill patients, including mortality, hospital length of stay, ventilator-free days, renal replacement therapy, and delirium.”

The multi-site study was designed to include this information from 20,000 adult patients who stayed at least 24 hours in an ICU. Rich data analysis is possible due to a REDCap data management system built by Vanderbilt University and more recently, database management by UMSOP’s Pharmaceutical Research Computing center. There are regular updates to the working group, and due to word of mouth and excitement generated in the field, there have been requests to include other patients and settings, such as pediatric patients, burn units, and others with very specific urgent clinical care needs.

“We actually ended up in a position where people are reaching out to us,” Heavner says. There are now 65 sites participating with 169 critical care pharmacists and 36,000 ICU patients.

Desperate Need for Inclusion

C. Daniel Mullins, PhD, a professor in P-SHOR, says one of the most crucial parts of the clinical trials process — besides pursuing the actual science itself — is to secure the trust and active participation of those diagnosed with specific diseases, who are on certain medications or for those who altruistically want to help further research advances that can benefit others, if not themselves. You can have healthy participants in clinical trials research.

As executive director of UMSOP’s PATIENTS Program, Mullins seeks to proactively educate citizens on the value of clinical trials, how they work, and how they can contribute. He says too often people feel excluded and unheard.

“There are many patients who still don’t understand clinical trials, and the PATIENTS Program is trying to change that,” says Mullins.

That starts with education, he says, and with actively making available information that they can better understand and that empowers them to make informative choices. It can be something as simple as giving them visuals instead of lengthy and hard-to-understand written instructions.

“The goal is to make materials more accessible and inclusive, more understandable, more patient-centered,” says Mullins.

“So, if you’re a visual learner, you can watch a video versus read a document. It’s still the pertinent information that’s critical — and making it more accessible to them in their preferred form.”

Mullins and his colleagues say that, at the end of the day, the PATIENTS Program seeks to engage patients who desperately want to see advances in a certain arena as well as people willing to volunteer for research more broadly.

“We aim to provide the information they need to make informed choices and educated decisions,” he says. “We want to instill confidence and trust in science; not just increase research participation. But the greater the numbers and diversity of participants, the greater the relevance to all who can benefit.”

More and Better – The Beauty of Partnerships

Clinical trials, by definition, are more — more data, more input, more measurables, and therefore, better interpretation into what matters most for the patients themselves.

Not only do researchers at the School enjoy a collaborative environment with one another, says Shapiro, but also with the other schools at the University of Maryland, Baltimore (UMB) and with the 12 hospitals within the University of Maryland Medical System. “We also benefit from our unique proximity to the National Institutes of Health, the FDA, the pharmaceutical industry, and other academic institutes like Johns Hopkins University who fund clinical trials and are partners on projects.”

For all those at UMSOP involved in clinical trial work, there’s one recurring theme to finding success:

“Collaboration,” says Shapiro.

“It takes a village,” says Stinchcomb.

Mullins echoes that sentiment from the patient and public perspective, as well.

“The feedback has been encouraging,” he says. “Through the PATIENTS Program, this is the first time, many say, that they’ve been listened to and heard regarding clinical trials and research.”

Kimberly Claeys, PharmD, PhD, an associate professor in P-SHOR who serves as a local site principal investigator for clinical trials within UMSOP, credits the collaboration at UMB, across the University of Maryland Medical System, the Veterans Affairs Medical Center, and other sites such as Johns Hopkins Hospital, and the public as critical to ultimate clinical trial success.

“How we work with our colleagues across schools, universities, and medical systems has done a lot to optimize clinical trial results,” she says. Still, success is not immediate. Clinical trials take time, typically years from start to completion, from lab to actual patient
intervention.

“It takes a lot of patience and forethought,” says Claeys, “therefore, we constantly assess and reassess the tools and resources available to ensure they’re optimum to increase patient participation, improve clinical trial success, and, ultimately, patient outcomes.”

And, she adds, “We publish the results of our trials with the goal of helping others more broadly to implement the same to improve their outcomes.”

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