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UTGSM Faculty Recognized for Clinical Trial Enrollment Success

Through high quality, high volume enrollment, University of Tennessee Graduate School of Medicine (UTGSM) faculty and colleagues in the Office of Clinical Trials at The University of Tennessee Medical Center are making an impact in clinical trials with national sponsors.

Partnerships with pharmaceutical and health care technology companies and participation in their clinical trials is one way UTGSM physicians offer their patients new treatment options.

Recent examples include efforts by Oscar Grandas, MD, Professor and Chief of the Division of Transplant Surgery and Ben Shepple, MD, Clinical Assistant Professor of Medicine in the Division of Cardiology. Both were recognized for high recruitment and invited to participate in additional trials with sponsors including Humacyte and GE. In addition, Larry Kilgore, MD, Chair and Professor of Obstetrics and Gynecology, has received support for several studies through the Gynecological Oncology Group (GOG) Foundation.

Paul J. Hauptman, MD, UTGSM Dean, said, "Growing our footprint in clinical trials is a major element of our strategic plan to advance our research endeavors. Participating in these studies allows us to provide our patients with the most innovative treatment options available."

More about recent faculty studies:

Dr. Grandas collaborated on a study with Humacyte, Inc (entitled: A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End-Stage Renal Disease) which was designed to examine Humacyte’s tissue-engineered vascular conduit for hemodialysis access compared to the current practice of surgically created autologous arteriovenous fistula.

The success of trial enrollment by Dr. Grandas, the study's principal investigator, and his study team resulted in the award of a second Humacyte study that focuses on blood vessel replacement or reconstruction in patients with life or limb-threatening vascular trauma. Dr. Grandas is working across multiple teams including Trauma, Vascular Surgery, and Occupational Therapy in order to enroll and care for patients participating in the study.

Dr. Shepple is collaborating on a cardiac imaging study with GE Healthcare using a novel agent and positron emission tomography (or PET) to assess patients suspected of having coronary artery disease.The UTMC became the first site world-wide to enroll patients in the study in 2018.

"We are one of the highest international enrollers," said Janet Parkey, Director-Research Compliance & Administration for the Office of Clinical Trials, the administrative hub for this type of research at the medical center. "Along with the study team's great work, our focus on generating meaningful data has resulted in the award of a second study with GE Healthcare, which we anticipate opening soon."

Dr. Kilgore has created a study team with Kristopher Kimball, MD, Residency Program Director, and Jonathan Boone, MD, Residency Mentor Director, that has resulted in several clinical trial opportunities awarded through the GOG Foundation with pharmaceutical sponsor funding. Examples include "RUBY", designed to evaluate the novel anti-cancer drug TSR-042 for patients with endometrial cancer; "GOG-3041", which will evaluate the efficacy and safety of a monoclonal antibody for the same condition; and "GOG-3037", designed to assess the efficacy of tisotumab vedotin in the treatment of advanced cervical cancer.

Many other clinical trials across multiple different disciplines such as cardiology, oncology and women’s health are currently underway. For information, please refer to the website of the Office of Clinical Trials on The University of Tennessee Medical Center campus or call 865-305-5120.

Posted: January 15, 2021


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