Investigators in the Yale School of Medicine Section of Digestive Diseases are conducting clinical trials in a variety of areas, including fatty liver disease, hepatitis, inflammatory bowel disease, and primary sclerosing cholangitis. The studies serve to help patients with complicated conditions who either have no treatment options or who would like to try novel therapies.
“These trials can improve patients’ quality of life in the short term when there isn’t anything available on the market that is helping them,” said Jill Gaidos, MD, associate professor of medicine (digestive diseases). “The studies also provide insights into possible therapies that will work for our patients in the long term.”
But initiating and running clinical trials or studies can be daunting, Gaidos said. In her role as vice chief of clinical research for Yale Digestive Diseases, she works with investigators to facilitate all aspects of the research process, including feasibility surveys, nondisclosure confidentiality contracts, budgeting, participant recruitment, and grant funding.
“We want to provide a clear pathway and walk investigators through the different steps to ensure that the process of setting up a clinical trial isn’t a barrier,” she said.
While Gaidos facilitates research for the section’s investigators, Lesa Moemeka, RN, assistant director of clinical research, does the same for study coordinators. She joined the section in September to help grow the program. In her new role, she serves as a point person for study coordinators, onboarding them, answering their questions, and providing training.
Currently Moemeka is focused on streamlining the program and increasing opportunities for team building. “My hope is that even though people are doing different work in different disciplines within the section, we can get everyone on the same page in terms of how to run clinical research in the most efficient way,” she said.
Streamlining will allow the section to take on more studies and increase recruitment, enrollment, and retention of study subjects, Moemeka added.
Both Gaidos and Moemeka are excited about the new Digestive Health Center in North Haven, which integrates research with clinical practice to facilitate patient and clinician access to clinical trials. The research space at the facility includes a workspace, storage area, and lab room with a refrigerator, freezer, incubator, and centrifuge. The facility enables patients who participate in clinical trials to do their study visit and their clinic visit at the same time.
As they work to enhance clinical research in the section, Gaidos and Moemeka are already creating efficiencies that they hope will advance the field.
“If we can help investigators and study coordinators with improvements and make the process easy for them, then they can teach the next person that comes along,” Gaidos said. “We can pay it forward for each other.”
Since forming one of the nation’s first sections of hepatology more than 75 years ago and then gastroenterology nearly 70 years ago, Yale’s Section of Digestive Diseases has had an enduring impact on research and clinical care in gastrointestinal and liver disorders. To learn more about their work, visit Digestive Diseases.