Clinical Trials: The Bridge Between Discovery, Practice

(EDITOR’S NOTE: This story was previously published in the fall 2025 issue of the UB Medicine alumni magazine.)

By Dirk Hoffman

There are usually about 300 clinical trials at any time that are actively enrolling patients at UB. Of these, more than 90% are in the Jacobs School of Medicine and Biomedical Sciences.

All the work that goes into drug development would amount to nothing in the absence of clinical trials, according to Sanjay Sethi, MD, assistant vice president for health sciences and medical director of UB’s Clinical Research Office.

With rare exceptions, approval of a new medication requires at least two clinical trials where the medication is compared to placebo. These trials must be double blind (neither the participant nor the investigator knows whether the patient is receiving the medication or placebo) and randomized (the allocation to placebo or drug is by chance). 

“The new drug has to be better than placebo in both trials to obtain FDA approval — its success has to be reproducible,” says Sethi, professor of medicine and chief of the Division of Pulmonary, Critical Care and Sleep Medicine in the Jacobs School.

Clinical trials are also essential to prove that a drug and treatment protocols are safe. They follow strict ethical and regulatory guidelines, ensuring that new treatments are thoroughly tested for safety and efficacy before they reach the public.

“Though all medications can have adverse effects, the trials help us decide that the benefit of the medications outweighs the risks,” Sethi says.

A recent clinical trial success story at the Jacobs School is the novel approach developed by Andrew H. Talal, MD, MPH, and colleagues to cure hepatitis C virus in people with opioid use disorder using facilitated telemedicine.

The researchers explored the effectiveness of integrating telemedicine into opioid treatment programs (OTP) for hepatitis C management, thereby removing the need for off-site referrals.

In a five-year study of OTPs in New York State, the researchers enrolled 602 participants and found that 90.3% of those in the telemedicine arm at an OTP were cured of HCV infection compared to 39.4% of participants referred to an off-site specialist. 

The groundbreaking results were published in the Journal of the American Medical Association and Talal was subsequently honored with a 2025 Top Ten Clinical Research Achievement Award from the Clinical Research Forum, a research institute based in Washington, D.C.

“Successful hepatitis C cure is an extremely important milestone in the treatment of opioid use disorder,” says Talal, professor of medicine in the Jacobs School.

The work was supported by an $8.2 million award from the Patient-Centered Outcomes Research Institute and more than $3 million from the Troup Fund of the Kaleida Health Foundation.

Talal and Kenneth V. Snyder, MD ’04, PhD ’02, associate professor of neurosurgery, radiology and neurology, jointly direct Gilead’s “On the Frontlines of Communities in the United States” (FOCUS) program at Kaleida Health.

FOCUS supports screening in the four Kaleida Health emergency departments for HCV and HIV and linkage to care.

The process improvements developed from the FOCUS project have established patient navigation services, community outreach initiatives, and improved collaboration with local health care providers, Talal says.

“We have engaged the entire community in an effort to improve linkage-to-care,” he says. “The results of these endeavors have led to improved rates of HCV eliminations among patients and improved detection within the health system ultimately leading to a healthier community.”

Leonard H. Epstein, PhD, SUNY Distinguished Professor of pediatrics and chief of the Division of Behavioral Medicine, is currently recruiting for a novel clinical trial that aims to overcome the food insecurity-obesity paradox.

Research has shown that women who cannot regularly access food they need are at a 50 percent greater risk of becoming obese, even though they do not consume more calories.

Epstein’s clinical trial will provide individually personalized meals to participants to improve their health by changing how they metabolize food.

Enrollment remains the biggest challenge in the execution of clinical trials, Sethi says.

“Multiple criteria have to be met to enter a clinical trial, as they are designed with an abundance of caution to minimize risk to participants,” he says.

The UB Participate in Research portal allows interested participants to search for actively enrolling clinical trials at UB. 

The Institute for Healthcare Informatics at UB also has the clinical data of all UBMD and Kaleida Health patients, and that can be queried by investigators to find potential participants. 

Sethi says the implementation of the Epic electronic health record system will also provide “a tremendous boost to clinical trial enrollment.”

“It has tools that allow matching of clinical trial enrollment criteria with patients’ clinical data, allowing the patients and their providers to be informed of their eligibility to participate in a trial,” he says. “Epic will also provide greater visibility to all active clinical trials to patients and providers, improving access to the trials.”