Abstract:
This case study outlines the pathway to conducting a pragmatic randomized controlled trial to evaluate an over-the-counter drug as an adjuvant to treat venous leg ulceration in the community. We describe the roles of persistence and luck in obtaining funding, the operational challenges of manufacturing a drug for a non-pharma funded trial, the importance of safety in the conduct of a drug trial even when that drug is commonly available, issues arising out of pragmatism in trial design, and the importance of good quality relationships in research.
