Changing Lives Through Research: Clinical Research Team Supports Over 100 Diverse, Complex Trials

Faculty in the Department of Surgery are currently leading or participating in more than 100 clinical trials. Each has a distinct protocol and requires management of numerous components – from patient recruitment and informed consent to electronic data entry and management of subject care throughout the trial. All of these activities must comply with regulations imposed by the Food & Drug Administration (FDA), National Institute of Health (NIH) Collaborative Institutional Training Initiative (CITI) and Health Insurance Portability and Accountability Act (HIPAA), which require the protection of Personal Health Information. To navigate those complexities, the Department relies on the Clinical Research Team, led by Jamie Jay Rothstein, RN, CCRC, CCRP. The team is supporting a wide variety of clinical trials that are open and accruing patients in the following specialties: bariatric, cardiothoracic, colorectal, pancreatic, transplant, trauma and vascular surgery. “As just one example, we’re supporting Dr. Adam Berger with a Phase 2 international multi-center trial of a compound that could function as a personalized vaccine therapy for melanoma patients,” Rothstein says. The team is working with Dr. Berger on nine other trials, including the INTEGRATE study, which is following patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. Additionally, the team is coordinating with Dr. Melissa Lazar on a clinical trial for patients diagnosed with breast cancer. The goal: to determine if standard of care lumpectomy (SOC) or SOC lumpectomy along with use of a MarginProbe® device offers greater safety and effectiveness. The device is designed to help surgeons quickly achieve “clean margins” by identifying cancerous (malignant) tissue in the surrounding tissue of the tumor in real time, rather than waiting for an assessment from the pathologist. Meet the Team: Rothstein’s team now includes six Clinical Research Coordinators (CRCs) and a Clinical Research Specialist. Matthew Isenberg, MSW, CRC II, joined the team in 2013. He identified, screened, interviewed and recruited eligible patients for the Department’s highest-accruing trial studying a pancreatic cancer vaccine from NewLink Genetics. He is now the lead coordinator on this trial. Karishma Kurowski, MPH, CRC II, joined the team in 2014. She is skilled in navigating protocols, collecting data, and obtaining informed consent, including educating subjects about clinical protocols, required therapies and procedures, and answering subject questions. Rupa Chowdary and Subikram “Raaj” Chandra are each lead CRCs for their own trials and are responsible for many activities – from preparing for subject visits and completing source documentation to entering data into the Electronic Data Capture system promptly after each visit. Another key responsibility: the time-consuming task of reporting adverse events (AEs) and serious adverse events (SAEs) per FDA guidelines. Other members of the team include Kyle Peer, who joined last year as a Clinical Research Specialist and Dee Rinaldi, CRC II, who joined the team in April. “Management of the protocol can play a critical role in a clinical trial’s success or failure,” Rothstein says. “I am proud of the talented team that we have assembled to support the Department’s robust and expanding clinical trial program.