The Directors: NCORP PIs discuss the growing complexity of regulatory oversight in clinical cancer research

Getting NCI clinical trials to the community has never been a simple matter. Has it been getting simpler or more difficult? How does research get done at the NCI Community Research Program sites? To take the pulse of research in the community, The Directors podcast invited two NCORP principal investigators to ask the questions usually posed to directors of America’s cancer centers: What’s keeping you up at night?NCI Community Oncology Research Program is a national NCI-supported network that brings cancer clinical trials and cancer care delivery research studies to people in their communities.In the May episode of The Directors, we speak with Amarinthia Curtis, the medical director of Gibbs Cancer Center and Research Institute and the PI of Upstate Carolina NCORP, and Jeffrey Berenberg, a co-PI of the Hawaii Minority and Underserved NCORP and the Core Clinical Member for Translational and Clinical Research of the University of Hawaii Cancer Center.In the U.S. cancer enterprise, bureaucracy is increasing, compliance burdens are growing, and clinical research is becoming harder to run efficiently. According to Amarinthia and Curtis, it’s frustrating that each agency has its own rules for what counts as a financial conflict of interest, how researchers must disclose it, how often disclosures must be updated, and what dollar amount triggers concern.“I printed out a graph that showed that 60% of the regulations that we have were created in the past 10 years,” Curtis said on The Directors podcast. “I wasn't aware exactly of that, but my heart, my body can feel that,” Berenberg responded.