Abstract

Implementation of strategic management tools improves wound care clinical trial outcomes

Author(s): Marina Malikova, Lauren Shifflett & Alik Farber

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 severe adverse events reported.

Results: The first venous leg ulcer study (VLU1), performed between September 2005 and January 2008, randomized 24 patients. The second study (VLU2), conducted between January 2010 and 2011, randomized 16 patients. Due to lack of prescreening in VLU1, the screening failure rate was 54.7 and 33.3% for VLU1 and VLU 2, respectively. The SPI at project completion was 0.58 and 1.0 for VLU1 and VLU2, respectively. VLU1 was behind schedule due to low and inconsistent enrollment caused by study staff changes and inexperience. Implementation of strategic trial management including interim monitoring of SPI, CPI and compliance resulted in VLU2 to be completed on schedule with higher randomization rates. The CPI at project completion was 1.0 and 1.2 for VLU1 and VLU2, respectively, indicating that both studies were conducted according to planned budget. The most common severe adverse event reported for both studies was cellulitis of target wound unrelated to study drug. Compliance assessment revealed 128 deviations for VLU 1 and 36 deviations for VLU 2. Most common categories, for both studies, included out-of-window visit and missed study procedures.

Conclusion: Internal auditing is a critical tool for improvement of site performance in prospective wound care studies. Implementation of strategic management tools yielded higher enrollment and better compliance rates for the VLU 2 study.