Technical Guidance for Designing Diagnostic Clinical Studies
1 Hour Video | Robert DiTullio, Beaufort
Clinical professionals within the diagnostic industry are given the difficult task of not only proving a test’s safety and effectiveness, but also demonstrating how the product is preferred over those already on the market. In 2013, the FDA published draft guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices to be used in parallel with the 2007 Guidance on Reporting Results for Diagnostics Test Evaluations. These guidance documents provide a solid framework for the design and analysis of diagnostic clinical studies, a critical aspect to the overall success of a diagnostic product. In order to run a successful study, diagnostic clinicians must take a proactive approach to study design and understand the key requirements for compliance.
- FDA diagnostic regulatory guidance and updates
- Methods for framing study goals, recruitment and site selection
- Comparison of clinical outcome studies and clinical performance studies
- Best practices for collecting clinical evidence
Participants that will find this webinar most beneficial will be those involved in diagnostics companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Regulatory Operations
- Clinical Trials
- Clinical Operations
- Companion Diagnostics
- Quality Affairs
Robert Di Tullio is the Senior Vice President of Global Regulatory Services at Beaufort, a global contract research organization specializing in the IVD industry with expertise in diagnostic clinical research, regulatory affairs, quality assurance and staffing services.
Mr. Di Tullio is an accomplished regulatory affairs professional with over 40 years’ experience in the in vitro diagnostics industry with the last 28 years in regulatory, clinical and quality management. Mr. Di Tullio provides vision, strategic insight and leadership to promote commercial success while assuring compliance with global regulations and initiatives. He is responsible for planning and managing engagements that involve regulatory issues in a manner that delivers the best solution for clients. Prior to joining Beaufort, he was Vice President of Global Regulatory and Clinical Affairs for Alere and held similar positions at ProteoGenix, Sequenom, Siemens Medical Solutions Diagnostics and Diagnostic Products Corporation.
Mr. Di Tullio holds a bachelor’s degree in biology from Saint Joseph’s University. He is currently the President of Di Tullio Consulting, Inc., the industry liaison to the Clinical Laboratory Improvement Advisory Committee (CLIAC), and a long-time member of the Regulatory Affairs Professionals Society (RAPS). Mr. Di Tullio was also the co-chair of the AdvaMed Diagnostics Task Force from 2007 to 2013, and was an advisory board member for the Medical Device graduate degree curriculum at the University of Southern California.
1 Hour Video | Jennifer Geettert and Lisa Schmitz Mazur, McDermott Will & Emery
1 Hour Video | Matthew Walenciak, ConvaTec