The Protocol Review and Monitoring System (PRMS) in the University of Colorado Cancer Center’s Clinical Trials Office is under new leadership.
CU Cancer Center member Cindy O’Bryant, PharmD, professor and associate dean for academic and faculty affairs at CU’s Skaggs School of Pharmacy and Pharmaceutical Sciences, is the new chair of the PRMS, which reviews cancer-related clinical trial applications to make sure they demonstrate scientific merit and support the CU Cancer Center’s institutional mission. O’Bryant, who has served on the PRMS review committee for the past several years, was previously PRMS deputy chair.
“As a National Cancer Institute-designated comprehensive cancer center and an academic medical institution, our job is to move the needle on patient care and advancement in oncology,” O’Bryant says. “These clinical trials really allow us to achieve that mission.”
The human touch
Clinical trials are research studies that involve people. They are the final step in a years-long process that begins with laboratory research and animal models. Clinical cancer trials are designed to answer questions about new treatments or new ways of using old treatments and how well they work. These trials may test drugs or vaccines, ways to perform surgery or deliver radiation therapy, or combinations of many treatments. When researchers at the CU Cancer Center start putting together clinical trials, they bring all of their supporting information to the PRMS as a first step in the process.
“In the review process we may just approve a study and they’re good to go, and sometimes we approve them with what we call stipulations, which means we need clarification on some aspect of the trial, but not necessarily a change in the protocol,” O’Bryant says. “There also are cases where we will ask for modifications, where we go back and give the principal investigator comments and some thoughts about what we think is needed within that protocol to improve it from a scientific merit or feasibility standpoint.”
CU’s Colorado Multiple Institutional Review Board (IRB) is ultimately responsible for approving all clinical trials at the CU School of Medicine; one of the PRMS’s goals is to help cancer-specific trials meet the CU IRB’s criteria. PRMS members meet twice a month to review prospective trials, as well as to check in on the progress of trials that are already in progress.
“We typically will review studies every three to six months, just to make sure that those trials are meeting their goals,” O’Bryant says. “We look at enrollment data to determine if people are on track to meet their accrual goals, and to see if there’s anything that we can do from a resource standpoint, as far as connecting people with resources if that’s helpful.”
Witness to impact
O’Bryant, who has a BS in biochemistry and zoology from the University of Tennessee and a Doctor of Pharmacy degree from Mercer University Southern School of Pharmacy, first came to what was then the CU Health Sciences Center in 1999, as a resident in oncology pharmacy. She has seen a lot of changes since then, including a huge growth in research and clinical trials. As a longtime member of PRMS, she is excited at the opportunity to see the creativity of CU Cancer Center members as they design clinical trials not just of medications, but of new methods of prevention and promoting behavioral health.
“The research is very diverse, and it shows you what we can do as one cancer center — the power that we have, and the progress that we can make,” she says. “As part of PRMS, I get to see a much broader picture of the work that we're doing here on campus, from the pediatric to the adult side. It’s really interesting to see the amazing work our faculty are doing here to create change and have a significant positive impact on our patients.”