Recent controversy over the risk factor status of elevated lipids and lipoproteins in coronary heart disease morbidity and mortality in elderly adults underscores the need for a properly designed controlled clinical trial testing the effect of cholesterol reduction in this population. HMG CoA reductase inhibitors are effective cholesterol-reducing agents with minimal adverse effects and would serve well as the drug class of interest. This proposal would establish at the University of North Carolina's Collaborative Studies Coordinating Center (CSCC) a coordinating center for a pilot study testing the feasibility of a larger trial of HMG CoA reductase inhibitors in elderly persons. The CSCC proposes to: (a) collaborate with investigators in the design of a cost-effective study protocol; (b) lead in the creation of appropriate data collection instruments; (c) provide administrative support (e.g. meetings arrangements and minutes, central communication, manuscript production); (d) develop and implement a data management system; (e) train clinic staff, write a detailed manual of operations, and provide clinic support (e.g. protocol interpretation) during the study; (f) monitor and maintain data quality at clinics and laboratories; (g) produce statistical reports for investigators and monitoring board; and (h) coordinate publication efforts. Specific plans for meeting these aims, as well the CSCC's experience in such activities for other collaborative cardiovascular research, are detailed. It is suggested that the pilot study be a paper-based data collection system with centralized processing at the CSCC. Software developed for pilot-study data management will be a prototype for a data management system to be distributed to clinics for the larger trial, if conducted, thus saving development time and costs. Also discussed are issues pertinent to the design of the pilot and main trial.
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