Twin Cities Chapter In Person Event: Study Design Essentials for Regulatory Affairs: From Single-Arm

Registration Fees & Deadlines

Learning Objectives

By the end of this session, participants will be able to:

• Differentiate between single-arm studies and multi-treatment RCTs, including Bayesian and other adaptive study designs, and identify when each approach is most appropriate
• Compare observational data and randomized controlled trials, discussing pros and cons such as internal vs. external validity and methods to enhance observational evidence (e.g., propensity scores, MAIC)
• Understand key statistical concepts used in medical device clinical research, including common regulatory areas of concern and statistical pitfalls, such as:
  • The estimand framework
  • Handling missing data
  • Use of external comparators

Who Should Attend?

This session is designed for:

• Regulatory affairs professionals (all levels)
• Clinical research and clinical affairs
• Medical safety
• Biostatistics and data science partners
• Anyone involved in generating, interpreting, or defending clinical evidence for medical devices

Why Should You Attend?

• Understand when single-arm studies, RCTs, and Bayesian/adaptive designs are most appropriate
• Learn how regulators view different types of clinical evidence
• Compare observational data vs. randomized trials, including strengths, limitations, and regulatory considerations
• Gain familiarity with methods used to strengthen observational studies (e.g., propensity scores, MAIC)
• Recognize common statistical pitfalls that can lead to regulatory questions or deficiencies
• Improve confidence when discussing statistical concepts with clinical, statistical, and regulatory stakeholders

Agenda

5:30 – 5:40 PM | Welcome & Introductions
5:40 – 6:10 PM | Overview of Clinical Study Designs for Medical Devices

• Confidence intervals, P-values, type I error, and power
• Single-arm studies
• Randomized controlled trials
• Bayesian and adaptive designs

6:10 – 6:40 PM | Observational Data vs. RCTs

• Internal vs. external validity
• Regulatory expectations
• Methods to strengthen observational evidence (propensity scores, MAIC)

6:40 – 7:05 PM | Statistical Concepts & Regulatory Pitfalls

• Estimand framework
• Missing data considerations
• External comparators and common agency concerns

7:05 – 7:30 PM | Practical Examples, Discussion & Q&A

Speakers

Keith Hebert
Chief Operating Officer,  Heart Rhythm Clinical and Research Solutions, HRCRS

Keith brings 27 years of expertise in global medical device clinical research and regulatory strategy to drive patient access and deliver evidence that matters. With a BS in Biomedical Engineering and an MBA, he has leveraged deep experience across clinical operations, regulatory market access in over 51 countries, and more than 60 clinical studies to exceed customer, client, and patient expectations.

Known for his operational excellence and talent for building high-performing global teams, Keith leads with a passion for results, a bold challenge to conventional thinking, and a commitment to developing the next generation of clinical and regulatory professionals.

Kurt Stromberg
Distinguished Statistician and Technical Fellow Medtronic Cardiac Rhythm Management Clinical Research

Kurt has over 20 years of experience as a statistician and clinical trialist in the pharmaceutical and medical device industry.  Most of his career has been spent designing and analyzing data from cardiology trials investigating novel pacing, defibrillation, diagnostic, and heart failure therapies.  He has participated in 3 FDA scientific advisory panels and multiple IDE and PMA submissions, as well as numerous other regulatory interactions supporting worldwide device approvals. 

Kurt is known for his pragmatic approach to clinical trial design, cross-functional engagement, and ability to clearly explain complex statistical topics.

Location

St. Cloud State University - Plymouth
9750 Rockford Rd
# 100
Plymouth, MN 55442

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions