Organization: The Center for Clinical Research conducts Phase I-IV clinical trials in the area of chronic cancer and non-cancer pain medicine. The Center has been operating under its current name for 26 years with affiliations at Wake Forest University Baptish Health and Novant Medical Center (both 1000+ bed teaching hospitals). The pain medicine trials include pharmaceutical and non-pharmaceutical (device) trials. They include pilot studies, proof-of-concept trials, and pivotal trials for FDA registry. The center does single site and multi-center trials. We are often Principal Investigators for large, multicenter, national trials. We also host and direct multi-center trials including a recent $3M effort of warwounded patients who are active military or veteran administration patients. We are responsible for protocol design, all data collection (CRFs), statistical development, and site monitoring for the 8 different US sites. Overall, the center is participating in over 15 trials with a trial budget of $8-12M. There are approximately 25 current employees in the center. Drs. Leonardo Kapural and Richard Rauck continue to serve as principal investigators in the majority of trials performed at the center and are both active recruiters for these respective studies. Carolinas Pain Institute in association with the Center for Clinical Research saw over 22,000 patient visits in 2012.
Team: Leonardo Kapural, MD, PhD, Richard L Rauck, MD, Jill Brewer, Stephanie Wilson, Tina Strates, Terri Allen.
Relevant experience: Dr. Leonardo Kapural is Professor of Anesthesiology at Wake Forest University Baptist Health and lead investigator for numerous clinical trials. He is Director of Pain Services at WFUBH. Dr. Richard Rauck is associate professor of anesthesiology at WFUBH, president of Carolinas Pain Institute, president of the Center for Clinical Research, and president-elect of the World Institute of Pain. The team has current NIH-funded trials as well as industry sponsored trials, all in the area of pain medicine and many involving chronic low back pain. Five other physicians will participate in this project along with 6 fellows, residents, and the many study coordinators, marketing department, project assistants, and regulatory persons.
Main Tasks: Providing blood samples for WP2; recruitment and enrolment of patients for WP7; Leader: WP7; Participant: WP2, WP9.