This talk will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process.
The advice provided during the session will be based on Richard Kotz’s 25 years of experience gained as a statistical reviewer and biostatistics team leader at FDA’s Center for Devices and Radiological Health. He, along with his team of biostatisticians, has reviewed 100’s of medical devices for a wide variety of medical conditions. He has also participated in numerous FDA/sponsor meetings.
Utilizing this experience and expertise, Mr. Kotz will share insights into key topics related to successful study design, with an emphasis on those trial elements which were most likely to lead to poorly designed and executed clinical trials.
The discussion will provide best practices and tips on getting the most out of communications with the FDA. Other topic areas include:
- Making the most of feasibility studies
- The critical importance of pilot studies
- Common pitfalls in the design and conduct of pivotal trials
- Development and negotiation of non-inferiority margins in a non-inferiority trial
- Some important aspects of investigational site selection
- Communicating with FDA during the pre-submission and submission process
The live session includes a Q&A period with the audience. Participants are invited to submit their questions/comments in advance to Mr. Kotz through the registration form.
Richard Kotz, Senior Medical Research Scientist, Biostatistics, NAMSA
Richard Kotz who recently joined NAMSA, was a statistical reviewer and manager at CDRH’s Division of Biostatistics for the past 25 years.
During his last 10 years he managed up to 8 FDA statisticians reviewing clinical trials for Ob/Gyn, Urology, Gastroenterology, Renal, Respiratory, Diabetes, Oncology, Anesthesiology, Infection Control and General Surgery Devices. He and his team reviewed hundreds of clinical trial protocols and have worked closely with clinicians, engineers, scientists and counterparts in the medical device industry to develop efficient pilot and pivotal clinical trials to evaluate their medical devices. He has mentored over 20 FDA statisticians during his tenure at FDA and worked hard to make sure their accomplishments were recognized. He has also been involved in several statistical organizations in various capacities including president of the FDA Statistical Association and recent chair of the Medical Device and Diagnostic Section of the American Statistical Association. In 2016, he was awarded FDA’s 2016 Lifetime Achievement Award.
Who Should Attend?
- Clinical Trial Teams
- Clinical Operations
- Clinical Project Management
- Monitoring Managers
- Clinical Management
- Procurement Teams
- Heads of R&D
- Regulatory Affairs
- Outsourcing Executives
- Sponsor and CRO Employees
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.