The Georgia Clinical & Translational Science Alliance – Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI collaborate to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Course Description:

Basic considerations for designing medical device trials such as device complexity and limitations, resource constraints, availability of a control group, and key stakeholders (i.e., hospital administration, radiologists, and clinicians) will be discussed. Characteristics unique to medical devices will be further explored via case studies using adaptive trial design for device testing.

At the end of this course, the learner will:

1. Understand the basic considerations for designing medical device trials, e.g., proof of device safety and/or efficacy, device size, ethics, device costs, study controls, partnerships with hospitals and industry, and study endpoints.
2. Define adaptive trial design, identifying the advantages and disadvantages for using adaptive trial design for medical device studies.

Course Topics:

1. When do we do device trials?
2. Necessity of strong partnerships
3. Transcatheter versus transapical implants
4. Adaptive design trials
5. Registries versus trials

Speaker:

Frances Richmond, PhD, is a Professor of Regulatory and Quality Sciences (Teaching Track) and Director of the DK Kim International Center for Regulatory Science at USC. She was educated as a neurophysiologist (BNSc, MSc, PhD) at Queen's University, Kingston, Canada and then completed post-doctoral studies at the Université de Montréal and the U.S. National Institutes of Health (NIH). She possesses numerous years of teaching experience and expertise in research and industry, formerly serving as a professor and Associate Dean of Life Sciences at Queen’s University, conducting research as a clinical scientist at the Alfred E. Mann Foundation, consulting at Advanced Bionics Corporation, and more. She was the first woman to be appointed Director of a research consortium, specifically the MRC Center for Sensory-Motor Research, funded by Canada's Medical Research Council (1995-2000). After joining USC in 1999 as a professor, she founded the Department of Regulatory and Quality Sciences, previously holding the role of Chair. Dr. Richmond is or has been a member of five large US research consortia (NIH Engineering Research partnership, NIH Bioengineering Research partnership, Clinical and Translational Science Institute, Tobacco Center of Regulatory Science, Consortium for Technology and Innovation in Pediatrics). Dr. Richmond and her team have been responsible for the development and oversight of multiple undergraduate and graduate programs in the School of Pharmacy that provide certificate, MS and doctoral training in the regulatory and quality management of foods, dietary supplements, medical devices and drugs. fjr@usc.edu

Learner Level: Intermediate

Audience:

This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
• Review the entire activity
• Pass the quiz with 100% of questions answered correctly
• Complete the evaluation at the end
• Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
• Start Date: 09/30/2022
• Expiration Date: 09/29/2025

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.