As a CRO and research site, Lotus Clinical Research is nationally recognized for its experience and proficiency in bunionectomy research.
For bunionectomy trials, Lotus Clinical Research provides both site and CRO services. We can perform single-center bunionectomy studies within our own walls. When a multicenter environment is required, Lotus Clinical Research utilizes a network of five well-vetted, geographically diverse bunionectomy sites.
The key to success in bunionectomy research is minimization of variability and placebo response. To accomplish this, our CRO and site utilize the Lotus Clinical Research subject placebo response education toolkit. This toolkit has been successfully deployed when we serve as the single bunionectomy center and/or in multicenter bunionectomy trials when Lotus Clinical Research serves as the CRO.
Efforts are made to reduce variability among subjects in multicenter experiments by homogenizing the:
Average enrollment is 30 randomized subjects per month at the Lotus Clinical Research site. Screen failure rates are typically low, but are dependent on the specifics of the clinical protocol and its inclusion/exclusion criteria.
Phase | Sponsor | Enrolled by Lotus | Total Study N | Clinical Trials.gov Identifier |
---|---|---|---|---|
2 | Heron | 53 | 100 | NCT02471898 |
2 | AcelRx | 50 | 110 | NCT01710345 |
2 | Recro | 50 | 150 | NCT02284243 |
3 | Covidien | 89 | 320 | NCT01484652 |
3 | Covidien | 89 | 320 | NCT01743625 |
4 | Regenesis | 70 | 300 | NCT01694199 |
3 | J&J | 155 | 897 | NCT00613938 |
3 | Teva | 53 | 560 | NCT02487108 |