Abstract
Background: Clinical trials are designed to test efficacy and safety of new drugs. Trials testing biologics for wound care is a fast growing field. We have analyzed clinical trials testing fibroblast cell-based agents for chronic venous stasis ulcers (VLUs). These two studies had similar objectives, study design, comparable eligibility criteria and outcomes. Objective: To assess performance and compliance in two successive clinical trials testing cell-based therapeutics for venous ulcers in order to identify trends and improvement opportunities. Methods: A systemic internal audit of two prospective, randomized wound care clinical trials was conducted at Boston Medical Center. Enrollment rates, earned values, actual and planned costs were analyzed and compared. The schedule performance index (SPI) and cost performance index (CPI) were calculated and factors affecting enrollment rates were identified. Study compliance was assessed based on study protocol deviations. Safety profile was assessed based on seve...
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