Risk-based safety and quality management strategies in wound care trials at a tertiary, safety net hospital.

Objective: An analysis of risk factors affecting wound care clinical trials was performed to develop proactive risk mitigation strategies, and improve the safety and quality of trials conducted. Adherence to study protocol and compliance with regulatory requirements was examined, based on the rate of protocol deviations.

Method: Prospective, randomised clinical trials for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) were compared for rates/types of deviations from study protocols. Adverse events were analysed in enrolled participants. The rate and patterns of serious adverse events (SAEs) and non-serious adverse events (AEs) were compared between the two wound indications.

Results: In all, 15 trials with a total of 261 participants and 223 adverse events were included in the analysis. The DFU group was noted to have a 10.4% higher incidence of SAEs and a 7.3% higher incidence of having any AEs compared with the VLU group. Analysis showed a higher number of deviations (n=325) in VLU trials compared with DFU trials (n=128). Overall, VLUs and DFUs had rates of deviation of 1.9 and 1.4 per enrolled patient, respectively.

Conclusion: An understanding of the frequency/types of adverse events can contribute to the development of safety monitoring plans and risk mitigation strategies for wound care trials. Effective training and retention of research coordinators can reduce the number of deviations, and an understanding of the frequency and types of adverse events can inform safety management/risk mitigation plans.