Clinical Core

Principal Investigator: Charles M. Rudin, MD, PhD

A major barrier to research translation for many laboratory-based researchers is access to clinical research infrastructure and assistance with the regulatory complexities of early phase drug development in humans.  Even for experienced clinical researchers, early support for investigator-initiated clinical trials is difficult to obtain and markedly slows initial testing of promising novel agents.  The Clinical Core is directed by Charles Rudin, an experienced early phase clinical investigator and the Associate Director for Clinical Research for the Cancer Center. This Core provides access to investigators with concepts ready for clinical application to the full research infrastructure necessary for conduct of interventional therapeutic trials.  All investigators using this resource for initial launch of a novel clinical concept concurrently apply for independent peer-reviewed funding to support continuation of their clinical trials.  In fact over the past 4 years since grant initiation, almost all supported projects have ultimately obtained external funding support, from the NIH or other agencies. This allows internal Clinical Core support to be used to prime many more projects, i.e. to rapidly jump-start investigator-initiated clinical research projects of relevance to tobacco-related disease, without waiting for external peer review, parent committee review, grant processing, and grant award.