Advanced International Trials with Medical Devices
Full course description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated 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.
The course provides an industry perspective on clinical studies.Topics will include considerations of study site selection, navigation in partnering with an industry sponsor, purpose of industry sponsored clinical studies, identification of stakeholders, explanation of study drivers, and outside pressures on public companies.
- Industry perspective on clinical studies
- Study drivers
- Clinical strategy from beginning to market
- Why are clinical trials performed?
- Who are your stakeholders?
- Funding source considerations
- Cost: Risk: Benefit Analysis
- Clinical risks
- Business risks
- System risk analysis
- Study Drivers
- Identify claims
- General claims
- Specific claims
- Unique features
- Patient population
- Broad vs. limited patient population
- Identify outcome measures
- Clinical meaningful outcomes
- Strong signal
- Study design
- Design depended on therapy
- Study locations
- International trials
- Increase exposure
- Increase complexity
- International trials
- Identify claims
- How to partner with Industry
- Understand the purpose of the study
- Know your patient population
- Be responsive and complete paperwork on time
- Consider ways to customize the study
- Communicate often to align expectations
Tracy Cameron, PhD, is an internationally recognized researcher with over 25 years’ experience in the field of neuromodulation, over 20 years of industry experience and is currently an adjunct faculty member in Neuroscience at the Ohio State University, Columbus, Ohio. Dr. Cameron received her BS in Biochemistry from Queen’s University, Canada followed by MSBME from the University of Miami, and a PhD in physiology from Queen’s University, Canada. As a graduate student at Queen’s University Dr. Cameron evaluated the tissue reaction and stimulation efficacy of an implantable muscle stimulator. As a researcher at St Jude Medical Dr. Cameron worked closely with many research facilities and university labs to evaluate product performance and safety in many novel areas of stimulation. Dr. Cameron is an expert in clinical trial design and execution and has been involved in multiple product approvals through direct negotiation with regulatory bodies including FDA, TGA, TUV, MDA and CFDA. Dr. Cameron has contributed to research community by presenting at conferences and authoring numerous peer reviewed journal publications as well as several book chapters in the field of neuromodulation. Dr. Cameron is currently a consultant for several companies both large and small in the areal neuromodulation.
This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.
Learner Level: Beginner
Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 0.75 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.
Need Help with Registration? Please contact us at firstname.lastname@example.org or 404-727-9208.
Program Information: This is the fifth course in a seven session program. To complete the entire program and earn badge Click Here.