WVU Medicine Clinical Trials Help Establish New Protocols

MORGANTOWN — Clinical trials research develops safe and effective strategies to treat or prevent human disease and provide researchers with new ways to approach medical treatment that can improve or save the lives of patients. Historically, rural populations have been underrepresented in clinical trials, a disparity that WVU Medicine researchers are seeking to address.

“Over the past decade, there has been a push for broader patient representation in clinical trials,” said Dr. Sally Hodder, associate vice president for clinical and translational science and director of the West Virginia Clinical and Translational Science Institute.

“Cutting-edge clinical trials should be available to everyone. Just because you live in rural West Virginia doesn’t mean you shouldn’t have access to clinical trials. WVU Medicine has historically had some very good trial groups,” she said. “Recently, we have attracted world-class investigators, particularly in the WVU Cancer Institute, WVU Heart and Vascular Institute and the WVU Rockefeller Neuroscience Institute, which further accelerates our ability to bring cutting-edge trials to West Virginians.”

The institute, based at West Virginia University and funded by the National Institutes of Health, is working with the departments and institutes at WVU Medicine to develop a Clinical Trials Center of Excellence that will provide support for investigators through guidance and mentorship while facilitating quality data collection and adherence to federal regulations.

The Clinical Trials Center of Excellence, working with the Office of Sponsored Programs, also is working to improve the efficiency of clinical trial implementation.

The institute has implemented TriNetX, a data platform that brings many potential clinical trial opportunities to WVU investigators, while also providing investigators with an understanding of the feasibility of clinical trials that they are designing.

A broad spectrum of clinical trials is being conducted currently at WVU Medicine. They include WVU Rockefeller Neuroscience Institute studies looking at novel ways to treat Alzheimer’s disease, chronic pain, opioid use disorder and research to understand attitudes of young women regarding substance use and infectious disease prevention.

While many studies, particularly those involving the use of newly developed drug therapies, are conducted at WVU Medicine J.W. Ruby Memorial Hospital or the WVU Health Sciences Center, the institute has created the West Virginia Practice-Based Research Network, a 95-site network that allows patients and practices in rural areas to participate in research across the state.

“Rural populations have traditionally not been included in clinical trials because of geographic barriers, and this is something that we are actively addressing,” Hodder said.

The way clinical trials are conducted has changed over time to maximize patient safety. Human subject protection programs have been developed to ensure participants understand the potential risks and benefits of studies.

All clinical trials are reviewed by an institutional review board from the perspective of human subject protection. Trial participants are not enrolled until the board approves the trial, and individual participants sign a consent form stating they want to participate in the trial.

“When clinical trials are available, everyone is able to make their own decision about whether to participate or not,” Hodder said.

Individuals who are interested in participating in clinical trials can talk to their doctors about trial eligibility or visit online at clinicaltrials.gov to learn about trials that are being conducted.

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