Lotus Clinical Research has performed multiple osteoarthritis investigations as both a research site and as a CRO. We are experienced in the osteoarthritis flare model within subject crossover deigns and parallel group designs.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is an endpoint that is commonly used for osteoarthritis studies. Unfortunately, a common problem encountered when using the scale is that it is not always well understood by research personnel and/or study subjects.
In order to help remedy this issue, Lotus Clinical Research has developed a proprietary osteoarthritis training toolkit. This package has been successfully deployed in both single and multicenter osteoarthritis investigations over the past several years.
Provides study subject education via video training on using common osteoarthritis questionnaires effectively, avoiding placebo response, and the proper use of rescue medication.
Provides investigator and key study staff training focusing on appropriate study conduct. Specific issues that are addressed include:
Average enrollment is 15 subjects per month at the Lotus Clinical Research site. Screen failure rates average 20-25% based on specific inclusion/exclusion criteria and may be slightly higher if a washout period is required for randomization.
