Innovation and Clinical Study Design of Medical Devices
On June 9th CÚRAM hosted a morning focused on Clinical Evidence for Medical Devices with the guest speaker Dr. Gregory Campbell. Dr Gregory Campbell is the President, GCStat Consulting LLC, having retired in 2015 after 20 years as Director of the U.S. FDA’s Division of Biostatistics in the Center for Devices and Radiological Health.
Over 60 attendees at the event held in the Meyrick Hotel, were welcomed by Abhay Pandit. Martin O’Donnell, Director of the HRB Clinical Research Facility Galway gave a brief introductory talk on the landscape of clinical research and regulated clinical trials in the Irish context, the HRB Clinical Research Coordination Ireland network and the potential for conducting clinical evaluations of medical device here in Ireland.
Gregory then gave two keynote presentations the first on Innovation and Clinical Study Design of Medical Devices, and the second on Regulatory Innovations in the Design and Evaluation of Medical Devices. He has a wealth of experience and a unique viewpoint in developing and promoting innovative study design on behalf of the regulator and he has spearheaded much of the methodological innovation in the US FDA Center for Devices and Radiological Health in the past 20 years.
Gregory covered a wide range of clinical study designs and their advantages and disadvantages with a particular consideration for medical devices evaluations in comparison to those of trials of pharmaceuticals. He covered key issues and innovations in areas such as blinding, randomisation, historical data and single arm studies along with innovations in post-market evaluation.
In his second presentation, Gregory looked at the innovations on the side of the regulator and innovations from a statistical perspective which can increase efficiency of data collected while ensuring biased results are unlikely. He explained how the application of appropriate and innovative statistical methods in study design and analysis offers the ability to reduce costs for the developer, and reduce time to approval to market of effective devices for patients.
Later in the morning a seminar on The Role of Economic Evaluation in the Reimbursement of Medical Devices was given by CÚRAM and NUIG health economists Paddy Gillespie and Adam Raymakers. This joint presentation illustrated the key considerations in economic assessment of new therapies generally and the unique challenges for making these assessments for medical devices.
Finally, Tom Melvin from the HPRA presented on New EU Medical Device Regulations and the Impact on Medical Device Clinical Investigations. He highlighted the salient points for manufacturers, sponsors and investigators to be aware of with the incoming changes in regulation for device approval on the European market, and the implications for the design and conduct of clinical investigations in obtaining this approval.
More about Gregory: The President, GCStat Consulting LLC, having retired in 2015 after 20 years as Director of the US FDA’s Division of Biostatistics in the Center for Devices and Radiological Health. At FDA he was responsible for supervising 65 statisticians in the pre-market review of medical device applications and in statistical and clinical trial research as well as leading several FDA guidance efforts. Prior to joining FDA, after a PhD from Florida State University and a faculty position at Purdue University, he became a tenured scientist at the National Institutes of Health where he held several leadership positions. He is the author of more than 100 publications and is a Fellow of the American Statistical Association and the Society for Clinical Trials.