Joint Fellowship Training Program
Mentor:
Brandon D. Gallas, Ph.D.
Position and Organizational Affiliation:
Mathematician, Division of Imaging and Applied Mathematics (DIAM)), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), FDA
Email:
brandon.gallas@fda.hhs.gov
Phone:
301-796-2531
Running Title of Program:
Improving Clinical Trials for Imaging Devices
Research Project Summary:
Imaging devices, image processing tools, computer-assist products, visualization packages, and display devices represent a large regulatory portfolio in CDRH that is continuing to expand. A March 2008 CDRH panel meeting emphasized the need for new paradigms for the evaluation of these products using reader studies and standardized databases. These evaluations must be statistically interpretable, relevant for their intended use, and at reasonable cost. This project will investigate new, improved clinical trial designs and statistical methods, as well as develop and validate data analysis tools, which will lead to more powerful clinical studies of the efficacy of imaging devices for fewer resources.
Proposed project for IOTF fellow: Depending on the skills and interests of the fellow, a project will be developed in any of the following areas:
- developing mathematical and simulation demonstrations of potential to increase statistical power with new clinical trial designs and analysis methods
- writing software interface for image display and reader interpretation
- designing reader study protocols and analyses and executing them with novice readers and simulated images to demonstrate proof-of-concept under a controlled setting
- designing and executing reader studies with expert readers to tailor methods to the clinical environment
Regulatory Activity:
Training courses will be offered to the Fellow on the premarket and postmarket functions of CDRH, the importance of risk management in evaluating the safety of new medical products, how to conduct meetings, technical writing, and writing for sponsors. The Fellow will gain experience with the device approval process used in CDRH through exposure to actual submissions of imaging devices, computer-aided diagnostic (CAD) devices, and others. The fellow will assist in all aspects: the planning of trials, the review process, meeting with sponsors, writing letters to sponsors, and preparing/attending panel meetings.
