Establishing Value: Clinical Economics Multisite Study/Delivering 3 Clinical-Economic Studies in 1 Year


Our client needed to generate real-world evidence to demonstrate their product’s value (a minimally invasive procedure for women’s reproductive health) to the marketplace. They had already expended significant resources on non-comparative clinical studies that were nearing or at completion, but did not have economic evidence to support their technology or make comparisons to competing procedures. TTi developed a creative, cost-effective solution to generate as much comparative data as possible. We designed three distinct study efforts, including:  (1) a comparative cost study to assess 12-month health economic and clinical outcomes associated with fibroid treatment strategies; (2) a study that examined facility costs associated with fibroid treatment strategies; and (3) a retrospective case-match study of facility costs and outcomes associated with fibroid treatment strategies.  Services included protocol and CRF development; IRB approvals; site recruitment and contract negotiation; data management and data analysis; and manuscript development. The client was able to maximize R&D dollars to meet funding milestone of new clinical-economic data within a short time period. The client was able to clearly demonstrate their value story without investing in additional, large-scale clinical studies. Four peer-reviewed publications have been produced as a result of these studies. The positive results of these studies have attracted new potential investors for the client and resulted in rapid expansion in positive payer coverage for their technology. Within the first 6 months of 2020, our client’s technology gained health insurance coverage of more than 50 million lives.

We spoke with a couple of different vendors. TTi was the only group that understood our long-term research and vision and provided very practical steps to take us down that path. TTi has been an enormous force in helping us develop a robust research program. We greatly appreciate the collaboration.

VP, Clinical Affairs, Small Medical Device COmpany