A data manager training program for oncology clinical trials
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文摘
Recognizing the need for a formal data manager training program in clinical trials (CTs), the City of Hope (COH) National Medical Center has developed a two-day course which was first offered in November 1995 and will continue to be offered annually. Although focused in oncology, the course is useful not only for those just beginning or contemplating a career in this area, but also for data managers and clinical research associates (CRAs) in various fields of medical research who have never benefited from formal training. The first day of the course provides lectures on critical aspects in the design and conduct of clinical trials, including: the phases of a CT, the elements of a protocol, the Institutional Review Board, adverse drug reactions, evaluating response, and maintaining a research record. During the second day participants gain hands-on experience in how to: check patient eligibility, maintain flow sheets, calculate body surface area and drug dosages, determine dosage modifications, evaluate toxicities and response, and prepare for (and survive!) an audit. Actual cases and protocols are utilized in these sessions. The faculty for the course includes the COH Clinical Trials Coordinator, Quality Control Coordinator, Director of Research Subjects Protection, Investigational Drug Pharmacist, Director of Biostatistics, a Medical Oncologist, and an experienced Data Manager. Participants are eligible to receive 11.5 hours of continuing education units from the National Cancer Registrars Association (NCRA) or from the Society for Clinical Research Associates (SoCRA). This is particularly timely, as SoCRA is endeavoring to standardize the qualifications and caliber within the profession, and now offer a certification exam for the CRA. Program evaluations have been extremely positive, and the suggestion to expand the course to 3-5 days is being explored for the Fall 1996 session.