Devices
Statistics Collaborative, Inc. (SCI) has extensive experience working with sponsors to design, monitor, and analyze clinical trials evaluating the use of implantable medical devices and diagnostic devices.
At SCI we have served as the biostatistician on many industry-sponsored mock panels for circulatory devices. Companies use such panels to evaluate and modify the written submissions and verbal presentations they have prepared for Food and Drug Administration (FDA) Advisory Committees. Our experience with many FDA submissions and our own service on FDA Advisory Committees allow us to provide useful advice to sponsors. We evaluate the statistical analyses and summaries, assess the written interpretations, and advise on improvements.
We have served as voting members on Data Monitoring Committees (DMCs) charged with monitoring the progress of clinical trials that evaluate the efficacy and safety of devices. Our experience in this field allows us to provide sponsors with appropriate statistical input for the interim monitoring of their studies.
Examples of SCI’s work with devices:
- The GORE TAG Device®: We helped W.L. Gore & Associates, Inc. design an appropriate analysis plan and justification for the pivotal trial of this thoracic aortic graft device. Ethical concern necessitated historical controls in the trial. SCI designed and programmed analyses for the final reports of three sequential device trials in preparation for premarket approval (PMA) submission to the FDA. SCI also participated in strategy meetings and acted as the statistical representative for Gore at its FDA panel presentation.
- Implantable cardiac devices and software for disease screening: SCI has worked with regulatory consulting groups that help sponsors prepare final reports for FDA submissions and FDA panel presentations.
- Ophthalmologic devices: SCI has provided statistical consulting and analysis for a number of trials studying devices to correct visit in various eye diseases.