Pragmatic and Cluster

Randomized Clinical Trials

This one-day workshop introduces pragmatic and cluster randomized clinical trial designs, with a focus on evaluating interventions in real-world settings. Participants will learn how pragmatic designs differ from explanatory designs, using the PRECIS-2 tool to assess trial pragmatism across key dimensions. The workshop will also provide a high-level overview of cluster-randomized trials, where randomization occurs at an aggregate level with outcomes measured at the individual level. We will explore both the challenges and opportunities of these designs through case studies.

Instructor:
Kelley Kidwell, PhD (University of Michigan)

Workshop Dates and Times:
Tuesday, August 5, 2025 at 10:00am-3:30pm EDT
(New Workshop in 2025!)

Workshop Format:
One-Day Online Workshop and Recording

This workshop will provide a comprehensive introduction to pragmatic clinical trial design, emphasizing the importance of external validity and real-world applicability. Participants will learn how pragmatic trials differ from traditional explanatory trials, which focus on internal validity under ideal conditions. The workshop will introduce the PRECIS-2 tool, which helps researchers assess and refine the level of pragmatism in their trials across multiple dimensions, such as participant eligibility, intervention flexibility, and primary outcomes. Through interactive discussions, attendees will explore how to design trials that balance real-world feasibility with scientific rigor.

A key focus of the workshop will be on cluster-randomized trial (CRT) designs, where randomization occurs at an aggregate level—such as at the provider, hospital, or community level—while outcomes are measured at the individual level. We will provide an overview of different CRT designs, including parallel cluster-randomized trials, which maintain the same intervention assignments throughout, and stepped-wedge designs, which sequentially roll out the intervention to different clusters over time. The workshop will discuss when and why each design is appropriate, with consideration of logistical, ethical, and statistical factors. A high-level overview of essential concepts related to sample size calculations, intra-cluster correlation, and appropriate analytic methods for CRTs will also be covered.

Throughout the workshop, participants will engage with case studies to better understand the opportunities and challenges associated with pragmatic and cluster-randomized designs. Discussions will highlight key issues such as recruitment, contamination, and ethical considerations, as well as practical strategies for improving trial implementation and interpretation. By the end of the workshop, attendees will have a clearer understanding of how to design, conduct, and analyze pragmatic and cluster-randomized trials to generate evidence that is both scientifically robust and relevant to real-world practice.

What you’ll learn

  1. Differentiate between pragmatic and explanatory trial designs, using the PRECIS-2 tool to assess the level of pragmatism in clinical trials.

  2. Describe the key features of cluster-randomized trial (CRT) designs, including parallel and stepped-wedge designs, and understand when and why these designs are used.

  3. Understand the basis of statistical and methodological considerations for CRTs, including intra-cluster correlation, sample size determination, and appropriate analytic approaches.

  4. Identify common challenges and opportunities in pragmatic and cluster-randomized trials, such as recruitment, contamination, ethical concerns, and real-world implementation, through case studies and discussion.

Syllabus

  • Introduction to Pragmatic vs. Explanatory Trial Designs

    • The PRECIS-2 tool

  • Overview of Cluster randomized trials (CRTs)

  • Parallel Cluster Randomized Design

  • Stepped Wedge Trial Design and Analysis

  • Statistical Considerations for CRTs

    • analytic approaches

    • sample size determination

  • Challenges and Opportunities in Pragmatic and CRTs

Registration Options

Pragmatic and Cluster Trials

  • Professional
  • $249
  • Baseline Price for Faculty,
    Staff, and Other Professionals
  • Click Register Below
  • Trainee
  • $249 $167
  • 33% Discount for
    Students and Postdocs
  • Use code "TRAINEE" at Checkout

Combo 1: Pragmatic and Cluster Trials + SMART Design and Analysis

  • Professional
  • $748 $598
  • Baseline Price for Faculty,
    Staff, and Other Professionals
  • 20% Combination Discount
  • Click Register Below
  • Trainee
  • $598 $401
  • 33% Discount for
    Students and Postdocs
  • 20% Combination Discount
  • Use code "TRAINEE" at Checkout

Combo 2: Pragmatic and Cluster Trials + MOST Framework

  • Professional
  • $498 $398
  • Baseline Price for Faculty,
    Staff, and Other Professionals
  • 20% Combination Discount
  • Click Register Below
  • Trainee
  • $398 $267
  • 33% Discount for
    Students and Postdocs
  • 20% Combination Discount
  • Use code "TRAINEE" at Checkout

Note: All registration options for this workshop come with two things:
(1) The ability to attend the live recording of the 2025 version of the workshop on August 5, 2025
(2) Access to the video recording and materials of the 2025 version of the workshop after August 5, 2025

If this workshop is offered again in future years (e.g., 2026+), then you will have continued “evergreen” access to the new recordings and materials.

 FAQs

  • This workshop was custom built for researchers in the social, behavioral, medical, educational, implementation, and/or statistical sciences who are interested in pragmatic and cluster randomized clinical trials. It is designed to be accessible to such learners with varying degrees of statistical and coding backgrounds and skills (from none to expert). This workshop is introductory and appropriate for faculty, post-docs, staff, and graduate students.

  • Beginner to Intermediate

  • No prior experience is necessary, but some experience with clinical studies is encouraged.

  • We will illustrate the methods using R software.

    If you aren't interested in coding, this workshop is still for you as we focus more on conceptual framework and present example results from applying methods to funded, published trials.

  • slides, reading list