On any given day at the Naomi Berrie Diabetes Center, the Type 1 Diabetes (T1D) Clinical Research Team is working on anywhere from six to ten different clinical trials that involve dozens of people of all ages with T1D. Sometimes hundreds of people need to be recruited and screened to find the one patient who meets the research criteria.
Clinical research is an integral part of life at the Berrie Center. Under the direction of Berrie Center Co-Director and Principal Investigator Dr. Robin Goland, the J. Merrill Eastman Professor of Clinical Diabetes, the clinical research program is one of the best in the world. The Berrie Center participates in the majority of the major, T1D clinical trials that are currently available. The Berrie Center is a member of the NIH Type 1 Diabetes TrialNet Study Group, the Helmsley Type 1 Diabetes Exchange, the NIH TRIGR Study Group, the NIH Immune Tolerance Network, and the JDRF TUDCA in New Onset T1D study.
“We are definitely busy in this room,” smiled Sarah Pollak, RN the program coordinator who took over the job from recently retired Ellen Greenberg, who led the clinical research team since its first clinical trials began in 1998. Now, added Sarah, “it takes a team to run this program.”
In addition to Sarah, who is also a certified clinical research coordinator with an MS in Nursing Administration, the team includes Kim Pope, an RN and a former transplant coordinator, and Cecilia Uche, a recent Columbia graduate who plans on attending medical school next year. Jennifer Deliard is a part-time assistant whose job description includes everything from scheduling patient visits and accommodations to data entry and setting up test tubes. “Everyone is new to clinical research except me,” said Sarah who has been at the Berrie Center for 5 years. “They are very smart and very skilled, so the transition has been smooth.”
Said Kim, “Being a research coordinator is a lot like being a transplant coordinator in terms of how my day is structured.” Added Cecilia, “I knew a little about diabetes before I came but it’s amazing what I’m learning everyday. I’m impressed with all the new technology—knowing that there might be something doctors can do to one day prevent diabetes.”
While everyone on the team is familiar with each study, the distribution of labor is clearly delineated. Sarah does most of the recruiting and she said, “Kim and I are the RNs, so we do all of the patient visits—metabolic tests, drug infusions, blood collections, data collection, scheduling, sensor placement, etc. Kim is also extremely skilled in phlebotomy, which is a huge asset, since we have study participants starting at age 1 in TrialNet.”
Dr. Goland and Sarah share the human subjects regulatory work, with Sarah submitting modifications and continuing reviews to the Internal Review Board (IRB). Sarah maintains the regulatory binders and assists with study monitors.
Cecilia Uche coordinates the TRIGR trial. That trial, which divided two randomized groups of at-risk patients to receive different types of baby formula, is coming to an end, “so it is a lot of work collecting final data points, responding to queries, scheduling and organizing documents,” said Sarah. Cecilia also coordinates data abstractions for the Type 1 Diabetes Exchange and was trained to coordinate a portion of an upcoming new sensor study. She also coordinates the TrialNet study called Pathway to Prevention.
Opportunities for research trial participation are provided to Berrie Center patients at varying stages of T1D. There are currently three different prevention trials for people who are at high risk, but have not yet developed diabetes—including one that tests a new oral insulin drug. And for patients recently diagnosed with T1D, the Berrie Center is participating in a new, unique JDRF-funded clinical trial of a drug called TUDCA that could improve beta cell function.