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.

Description:

Differences between drug and device development and regulations, challenges with device clinical trials, utilization of sham surgery as a control for surgical medical devices, and changing requirements in the EU for clinical data and evaluation will be examined.

Course Topics:

1. Differences between Drug and Device development and regulation (US vs. Europe)
2. Devices: Single pivotal trial usually sufficient
   • Phases: FIM, Pivotal, Post-Market (“PMCF” in EU)
3. Drug: Substantial evidence is required -Phase I, II, III, IV
4. Drug vs. Device Development Cycle
5. Challenges with Device Trials – subject to frequent, incremental changes
   • Devices Primarily used by Healthcare Professionals
   • Learning curve, training, skill of the user: factors hindering device effectiveness
   • Difficult to blind
   • Life cycle is shorter
   • Software, radiation, material problems (complex engineering project)
   • Some devices are implanted
   • Coming with suitable control is difficult
   • Ethnical concerns with creating the placebo
     • Creating long “expected life” due to expense, finding individuals who can do so, failure analysis of retrieve devices, bench testing, and formal design reviews
   • Device companies may be small manufacturers
6. Sham Surgery – a control for surgical device trials
   • Placebo surgery - a faked surgical intervention that omits the step thought to be therapeutically necessary
   • Shift towards Evidence Based Medicine (EBM) since the 1980s
     • Ethical Dilemmas – can harm patient partaking in the surgery
   • History and Controversy
     • Favor - Necessary for rigorous experimental designs needed to exclude false positives
     • Examples: The “Transplant Case” and the “Runaway Train Case”
   • The 5 criteria developed for when harming a few to save many could be justified when:
     • A specific group is at risk from a harm causing event
     • Setting in which the harm (or risk) is diverted from the many to the few involve only individuals from the larger “at risk” group
     • Harm is diverted between large and smaller subsets of the originally “at risk” group
     • Harm will occur regardless of whether or not the outside agent diverts harm from the many to the few   
     • There is a reasonable and legitimate means for allocating risk between the few and the many
   • How these criteria are met for sham surgery
   • Informed Consent may not be enough
   • Sham surgery control – permissible or obligatory?
7. Case Study – Renal Denervation
   • Renal Denervation (RDN): a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation/ultrasound ablation aimed at treating “resistant hypertension”
   • Causing a decrease in fluid retention and hence blood pressure
   • First Device: SIMPLICITY HTN-1 (in June 2007), second study in June 2009, third study in 2011-2013 (big study); the first two studies showed significant differences but third study did not illustrate the same conclusion during the sham procedure
   • What Happened?  Biases (lack of blinding), fact of being a study alone can be causing an effect, “white coat syndrome”, learning curve (experience vs. “new” users, the nerves vary in location in the tissue, lack of biomarkers to see whether the nerve was affected by the device, medication compliance issue, patients being on different medications, and medical class interventions, placebo/Hawthorne effect
   • Approved in Europe but not in the USA
8. Changing requirement in the EU for clinical data and evaluation
   • Increasing EU requirements in recent years
   • 2010- Amended the directives
   • 2013- Responses from politicians due to scandals between 2010 and 2012
   • Mid 2016- Increased data regulation with audits and outlining requirements
   • 2017- Three change period ending in 2020
   • A Clinical Development Plan (CDP) is required as part of the CEP (for all classes of device)
   • EU MDR Requirements (and post-market clinical follow-up [PMCF])
   • “No grandfathering”- need to produce sufficient data to prove benefit/effectiveness of device
   • Question: What should the design of those PMCF studies be?

Speaker:

Keith Morel, PhD. is VP of Regulatory Compliance at Qserve Group; the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations.He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer) where he was responsible for the Internal and External audit processes, Management Review, QMS design & governance and the internal Training process.Dr. Morel was a Senior Project Manager for DEKRA Certification Inc. for 9 years.During his time at DEKRA he was lead auditor for CE (MDD) & ISO 13485:2003. While there, he performed more than 100 audits and more than 200 Design Dossier/Technical File reviews. He was also DEKRA’s senior cardiovascular product expert, as well as a drug-device combination product expert. Dr. Morel has also worked in R&D in the Medical Device industry in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products.He has both a Ph. D. in Plasma Physics (Nuclear Fusion) and a First Class degree in Physics from Imperial College of Science, Technology and Medicine, in the UK. In addition, he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification. Keith.Morel@Qservegroup.com

Learner Level: Beginner

Audience:

This course/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.

Contact Hours:

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 1.0 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 ene@emory.edu or 404-727-9208.

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