Design Considerations for Pivotal Clinical Investigations for Medical Devices

Why Should You Attend:

Each year, insufficient evidence of the safety and effectiveness of a medical device caused from incorrect study design, results in the delay or rejection of either the medical device application or studies conducted towards that application. This is very expensive for the medical device sponsor who has to do additional work or redo existing work. It is also very expensive for the FDA (or other regulatory authorities) who spend the time to review results from incorrectly designed studies.

To mitigate these issues and standardize the way industry design clinical studies, the FDA published the guidance “Design Considerations for Pivotal Clinical Investigations in Medical Devices” in late 2013. The FDA’s goal in publishing this guidance is to help device manufacturers select the appropriate trial design to:

  • Better support and improves the quality of safety & effectiveness data submitted to the agency
  • Lead to timelier FDA approval
  • Speed patients’ access to new devices

This webinar will introduce FDA’s guidance “Design Considerations for Pivotal Clinical Investigations in Medical Devices”. It will discuss the regulatory considerations for clinical study design, and will delve into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data.

This webinar will also discuss ways that are available to a medical device sponsor, for eliminating bias and variance, both in terms of the study design and the requirements for the personnel that will design and run the studies. Finally, it will touch on the study protocol and statistical plan and will discuss ways to use those to ensure the success of the study.

Areas Covered in the Webinar:

  • The Guidance
  • General Principles
  • Some Principles for the Choice of Clinical Study Design
  • Clinical Outcome Studies
  • Diagnostic Clinical Performance Studies
  • Sustaining the Quality of Clinical Studies
  • Summary
  • Q&A

Who Will Benefit:

  • Clinical Trial Physician / Doctor
  • Manager to Senior Director of
    • Regulatory Affairs
    • Quality Assurance
    • Clinical Research
    • Data Management
    • Data Monitoring
  • Institutional Review Board
  • Data Monitoring Committees
  • Clinical Investigators
  • Biostatisticians
  • Data Monitors

Instructor Profile:

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years experience in the Life sciences industry spanning project management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and works consults to Pharma / Biotech / Medical Device and CRO industry on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management. More recently, Ms. Bazigos co-authored Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is also on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Registry for Women’s Who’s Who.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703349?channel=limesfinder