From her office in the West Hospital, Dr. Amy Ladd views the results of a database query on her computer screen, regarding the number of active human research studies at Pauley.
“It’s up to 72,” she said.
Scrolling down through the listings, she stops to pull up an individual trial. The record shows everything from the investigators, protocols and informed consent forms to funding sources and important watch dates. Ladd prepared most of the records for submission to the VCU Institution Review Board [IRB].
“This is the system we use for keeping track of our IRB submissions. It’s the regulatory side,” she said. “The VCU IRB oversees all human subjects research at the University. They want to make sure that we are doing the best we can to protect the participant’s health, privacy and confidentiality.”
When she prepares the records, she tries to anticipate the questions that the IRB may have. She works to ensure that the studies are compliant with hospital, state and federal regulations.
As one example, some patients may consent to the study team saving their blood samples for future studies. “Having those blood samples for a particular patient population can be really valuable for a researcher who is looking for biomarkers to develop new drugs, for instance. But the IRB wants to make sure that we are very transparent about that when we consent the patients,” she said.
She also works with VCU School of Medicine’s Clinical Trials Office, which among other things, negotiates study budgets on behalf of the research teams and the Office of Sponsored Programs, which ensures contract language is acceptable to the University. Some studies may require an additional level of approval from other departments. For instance, cardio-oncology studies require the o.k. of the VCU Protocol Review Medical Committee, which is affiliated with Massey Cancer Center. Additionally, about half the studies are funded by industry, which receives approval by an outside IRB—though the documents are also still reviewed by the VCU IRB.
While she tends to work early in the approval process, she remains in close contact with the clinical research coordinators throughout the trial. Sometimes a PI will want to amend the trial, which requires additional IRB approval.
Ladd said she shares the same focus as other members of the team: “The number one concern is patient safety. We’re doing these trials to benefit science and keep VCU as a top research institution, but none of that matters if we’re not helping patients and keeping them safe.”
Ladd, who holds a Ph.D. in Pathology from University of Maryland, has worked at VCU Health for 15 years. Previously, she held translational research-based positions in the Department of Pathology and the Parkinson’s and Movement Disorders Center.
She has worked for Cardiology since 2015 and has enjoyed the transition to human clinical trials. “It’s a huge need. Cardiac disease is the top medical issue with people in the country,” she said.
When asked if she enjoyed reading about the trials, she smiled. “I love it. I enjoy being in the know on all the cutting-edge research that’s going on here.”
To learn more about specific trials, please visit ClinicalTrials.gov.