That’s My Job: Clinical Research

That's My Job: Clinical Research

Published on Monday, August 26, 2024

By: Danny Barrett Jr., [email protected]

Photos By: Melanie Thortis and Jay Ferchaud/ UMMC Communications

When an accident survivor or an infant in the NICU can go home within days of first needing medical help, a past or present clinical researcher and team members can easily be among the first to be thanked for advancements in treatments.

"Our research professionals at all levels - researchers, clinicians, support staff and administrators-are committed to ensuring the growth of research and to the achievement of groundbreaking results," said Chris Moore, senior director for clinical research. "Our collective commitment in designing studies, collecting data, engaging with participants, working with sponsors and overseeing regulatory and ethical requirements is essential to the success of clinical research at UMMC."

The job of kickstarting studies of all types often belongs to managers and administrators whose roles might not necessarily appear on the cover of a finished piece but are no less vital to positive outcomes for patients.

One is Sandra Tyler, administrator of the Institutional Review Board, which gives the final aye on all UMMC's academic and medical endeavors funded by grants.

Three panels comprised of 12 to 15 physicians, scientists and a community member unaffiliated with UMMC meet regularly and review studies submitted via Cayuse, Tyler said. From there, board members determine risk level for the human participants.

"We aim to protect the rights and welfare of all human participants in research studies," she said. "We see a lot of studies that might look at social or behavioral factors and how they affect people in everyday life. Or they might be chart review studies that might collect info on something that happened in the past and they want to study it for patterns.

"An example of a higher-risk clinical research study are drug studies," she said. "If they're investigating an experimental drug that's being administered to a study participant, the risk is considered greater than minimal since the participant will be given an experimental drug."

Tyler has spent 17 years assisting the research process at UMMC and has been in her current role with the IRB since February 2023. Previously, she worked as a clinical research regulatory specialist in pediatrics, the Clinical Research Support Program and in neonatology.

She counts her experience as a plus when serving as a conduit between the board and principal investigators on various studies.

"I have a lot of joy and satisfaction knowing I get to play a part in advancing research here in Mississippi," she said. "I have seen quality of life improved in studies such as acid reflux in pediatric participants or those with devices for children with holes in their heart. It is great to watch these studies being walked out from start to finish. It's so rewarding knowing that the research we do here is helping and making a difference in people's lives."

Some of those differences are made in the Clinical Research and Trials Unit, or CRTU, on 7 South in University Hospital. Cathy Hudgins is the nurse manager for the Clinical Research Support Program, or CRSP, which promotes research and development.

Hudgins and her team handle logistical support for physicians after protocols for a study are submitted.

"There are two parts to our business up here," she said. "One is CRSP and the other is the CRTU. I have a team of 12 RN and non-RN clinical research coordinators who help provide a place and a staff for physicians who head up clinical trials.

"If their department doesn't have the staffing or space to run the trial, whether it be their own protocol or from an industry sponsor or a device company, then my department is here to support them from startup to closeout. We can supply a coordinator to conduct study visits and handle all regulatory activities. We can also monitor their study budget and handle all the invoicing. We also have three MD trialists on staff who can assist."

The unit, opened in 2019, features 22 inpatient and outpatient participant rooms, an eight-chair infusion center, a lab for processing and shipping samples and four encounter rooms used for consenting and other private interactions with trial participants.

In her role with the CRSP, she's the first person principal and supporting investigators reach out to on the front end of nearly all trial requests. "I help work through the process of whether a trial is a good fit for us, asking how many enrollees do we expect and over what time frame," Hudgins said.

Currently, the unit is handling 54 active clinical trials in the unit, with another 15 in various startup stages, she said.

"I owe all our success in the research program and trials unit to my team here," she said. "If I could pick an 'A-Team' of people to work with for the rest of my time here, it would be these amazing people."

Hudgins is also an important cog for professional development at UMMC. She works as a preceptor in the ISCORE-RC clinical research coordinator certificate program funded by NIH and based at West Virginia University.

"We have eight research coordinators from UMMC enrolled in this program," she said. "It's in 23 states and it's a self-paced, hands-on, active training program. Along with Jamie Brown, who also works in clinical research operations, we guide their progress through the online portion, then work with them for the hands-on portion so they can earn the certificate."

The work of support staff is vital to answering some of the most elusive questions physicians try to answer to improve patient outcomes, said Dr. Abhay Bhatt, director of research in the Division of Neonatology.

"Clinical trials in Mississippi in research with newborns, for example, represent fairness and justice, when you think about it," Bhatt said. "So much new knowledge and therapies come about through trials, which means better outcomes, regardless of social and economic determinants of health."

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