he field of oncology is entering a new and exciting period of discovery. For the first time, our understanding of tumor genetics and basic cell biology is leading to the rapid development of new therapies. Our ability to put these treatments to use, however, is dependent on our ability to study them in a scientific and controlled manner in clinical trials. North Carolina is a state with a very rich tradition of cancer research and patient care. We have 3 National Cancer Institute (NCI) Comprehensive Cancer Centers while 17 states have none at all. In addition, the state is the headquarters for the Southeastern Cancer Control Consortium (SCCC), the largest Community Clinical Oncology Program (CCOP) in the United States. The American Society of Clinical Oncology lists almost 600 physician members in the state and over 600 research studies are in place at nearly 250 sites. All in all, the state of North Carolina is clearly a leader in cancer care. Yet, even with this great potential, we still struggle with the problem of enrolling North Carolinians with cancer in clinical trials. It is estimated that between 2% to 5% of the adult cancer population enrolls in cancer clinical trials nationally, and this estimate is widely cited. 1 However, this reflects only enrollment in National Cancer Institute trials and does not include studies sponsored by the pharmaceutical industry or developed locally at the university centers. Others have estimated that if all other treatment trials were included, the rate might be twice this estimate, if not higher. It is difficult, however, to confirm any of these estimates because there is a lack of reproducible methodology for measuring enrollment, a fact that reflects the fragmented, decentralized nature of trial development and management outside of NCI trials. As a result of this system, obtaining a comprehensive estimate of total trial enrollment would require contacting many trial sponsors and having them voluntarily share their trial enrollment information—a task which is yet to meet with success. Overall trial enrollment rates in North Carolina remain unknown, although enrollment estimates in NCI cancer treatment trials fall within the usual estimates of 2% to 5%. For the years 2002 through 2004, an average of approximately 2.5% of North Carolina adults diagnosed with cancer enrolled on NCI treatment trials. 2 This estimate has generally grown since the years 1995 to 1997, during which time approximately 2.1% of adults enrolled. This trend is favorable overall, but not all populations experience enrollment equally. For example, while analysis of minority enrollment is ongoing, there is evidence that African Americans enroll in trials at a substantially lower rate than do whites. 1 There is also wide geographic variation, with greater enrollment generally seen in more urban counties “Most patients who were on clinical trials rated their experience as positive and better than standard therapy.” John Feldmann, MD, FACP, is the medical director of the Moses Cone Regional Cancer Center. He can be reached at John.Feldmann(at)mosescone.com. William R. Carpenter, PhD,isaresearchassistantprofessorintheDepartmentofHealthPolicyandManagementattheUniversityof NorthCarolinaChapelHillSchoolofPublicHealth. Carrie Lee, MD,isaclinicalassistantprofessorintheDivisionofHematology/OncologyattheUniversityofNorthCarolinaatChapelHill. Thomas C. Shea, MD,isaprofessorofmedicine,directoroftheMarrowandStemCellTransplantProgram,andassociatedirectorfor theOutreachProgramattheUniversityofNorthCarolinaatChapelHillLinebergerComprehensiveCancerCenter. James N. Atkins, MD,isaprincipalinvestigatorattheSoutheasternCancerControlConsortium. T. Flint Gray, MD,isthepresidentoftheNorthCarolinaOncologyAssociation. COMMENTARY CancerClinicalTrialsinNorthCarolina John Feldmann, MD, FACP; William R. Carpenter, PhD; Carrie Lee, MD; Thomas C. Shea, MD; James N. Atkins, MD; T. Flint Gray, MD NC Med J July/August 2008, Volume 69, Number 4 306 T