Free

Clinical Evidence for Medical Devices

Event Information

Share this event

Date and Time

Location

Location

Ballroom, Meyrick Hotel

Galway City

Ireland

View Map

Event description

Description

CÚRAM invites you to join Dr. Gregory Campbell, formally Director of the U.S. FDA’s Division of Biostatistics in the Center for Devices and Radiological Health for a networking breakfast and a morning focused on Clinical Evidence for Medical Devices on Friday June 9th in Meyrick Hotel, Galway. The event consists of two talks presented by Dr. Campbell followed by two interactive seminars on Reimbursement and EU Regulations hosted by the CÚRAM Translation Group.

AGENDA

7.30am Registration, Breakfast and Networking

8.00am Welcome Address

8.15am Innovation and Clinical Study Design of Medical Devices, Followed by Q&A

9.15am Regulatory Innovations in the Design and Evaluation of Medical Devices, Followed by Q&A

10.15am Coffee break

10.30am Seminar 1: Reimbursement decisions in the context of medical devices

11.30am Seminar 2: New EU medical device regulations: Impact on medical device clinical investigations

12.30 - 13.00pm Wrap up and Finish


Innovation and Clinical Study Design of Medical Devices presented by Dr. Gregory Campbell

(40 minutes with 20 minutes discussion)

Summary: The choice of design of clinical studies for medical devices are much broader than for pharmaceutical drugs. While feasibility studies are considered, the primary focus is on innovative pivotal clinical studies for regulatory submission. The designs include masked (blinded) as well as unblinded randomized clinical trials as well as observational studies that use for the historical or other non-randomized controls, or objective performance criteria (OPCs) or performance goals. Innovations in postmarket studies are also discussed.

Regulatory Innovations in the Design and Evaluation of Medical Devices presented by Dr. Gregory Campbell

(40 minutes with 20 minutes discussion)

Summary: U.S. regulatory innovations are considered, including the Expedited Access Program, benefit-risk determinations, and the incorporation of patient preference information and real-world evidence into the premarket evaluation. Statistical innovations include Bayesian designs, adaptive designs, and propensity scores in non-randomized studies. Specialized areas are the regulation of mobile apps and use of companion diagnostic tests for precision medicine. The projects of the Medical Device Innovation Consortium (MDIC), a public–private partnership, are briefly discussed.

Seminar 1:

Reimbursement decisions in the context of medical devices presented by the CÚRAM Translation Group

Synopsis: The proliferation of new pharmaceutical products and technologies has placed increasing constraints on health service budgets. As such, the reimbursement of new health technologies needs to be systematically evaluated, often using economic evaluation. The methods to evaluate pharmaceutical products for reimbursement are well-established. However, these methods do not translate perfectly for medical devices. We will discuss potential issues that may arise in performing economic evaluation in the context of medical devices.

Seminar 2:

New EU medical device regulations: Impact on medical device clinical investigations presented by the CÚRAM Translation Group

Synopsis: The introduction of a revised EU medical device regulatory framework in Europe will have a substantive impact on clinical evidence requirements throughout the medical device life cycle. This is particularly pertinent with respect to the newly introduced regulatory provisions related to the registration, conduct and reporting of medical device investigations as part of clinical research and commercialisation activities.


Gregory Campbell, Ph.D.

Greg 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. 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 Ph.D. 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.

Share with friends

Date and Time

Location

Ballroom, Meyrick Hotel

Galway City

Ireland

View Map

Save This Event

Event Saved