Study Design Essentials for Regulatory Affairs: From Single-Arm to Bayesian Adaptive
Join the RAPS Twin Cities Chapter for an engaging and practical session focused on understanding clinical study design and statistics as they apply to medical device regulatory strategy. This session is designed to help regulatory professionals confidently interpret, communicate, and defend clinical evidence used to support device safety and effectiveness.
This workshop provides a structured, real-world introduction to clinical study designs commonly encountered in medical device development — from single-arm studies to randomized controlled trials (RCTs), including Bayesian and other adaptive designs. Through practical examples, attendees will explore how statistical choices impact regulatory submissions, benefit-risk assessments, and agency interactions.
Study Design Essentials for Regulatory Affairs is designed for regulatory professionals and close functional partners who want to strengthen their statistical literacy without becoming statisticians. The session emphasizes clarity, regulatory relevance, and effective cross-functional communication.
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
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 [email protected]. 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 [email protected] 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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Keith Hebert
Kurt Stromberg
