Modernizing Clinical Trial Design and Analysis to Improve Efficiency & Flexibility

RCT

drug-development

bayes

regression

endpoints

2020

2021

2024

2026

This presentation covers several ways to make clinical trials more efficient and to reduce the chance of ending with an equivocal result. Some of the approaches covered are Bayesian sequential designs allowing for study extension if results are promising, not being tied by type I assertion probabilities/α spending, using high-information longitudinal ordinal outcomes, and covariate adjustment.

Author

Published

April 30, 2026

UCLA Cardiology Grand Rounds 2020-10-23 | Video (better video below)
Vanderbilt University Department of Biostatistics 2020-11-18
Vanderbilt Translational Research Forum 2021-11-04 | Video
Consilium Scientific 2024-03-14 | Video and here
Seventh Annual Janice Pogue Lectureship in Biostatistics, Population Health Research Institute, Hamilton, Ontario, Canada 2024-12-05
Slides
Pictures
Video

Important Considerations in Trial Design for Flexibility & Efficiency

RRE 2026: Research RoundTable in Epilepsy, Washington DC 2026-04-30
Shortened version with outcome examples for epilepsy trials
Slides

---
title: Modernizing Clinical Trial Design and Analysis to Improve Efficiency & Flexibility
author:
  - name: Frank Harrell
    url: https://hbiostat.org
date: 2026-04-30
categories: [RCT, drug-development, bayes, regression, endpoints, "2020", "2021", "2024", "2026"]
description: "This presentation covers several ways to make clinical trials more efficient and to reduce the chance of ending with an equivocal result.  Some of the approaches covered are Bayesian sequential designs allowing for study extension if results are promising, not being tied by type I assertion probabilities/α spending, using high-information longitudinal ordinal outcomes, and covariate adjustment."
---

* UCLA Cardiology Grand Rounds 2020-10-23 | [Video](https://youtu.be/1liOEyeDRbU) (better video below)
* Vanderbilt University Department of Biostatistics 2020-11-18
* [Vanderbilt Translational Research Forum 2021-11-04](https://my.vanderbilt.edu/translationalresearchforum) | [Video](https://youtu.be/ANNRSgpFPvM)
* [Consilium Scientific](https://consilium-scientific.org) 2024-03-14 | [Video](https://youtu.be/FI2ncRU9PPQ?si=zquTF6Qi8TGW8Qjb) and [here](https://www.linkedin.com/video/live/urn:li:ugcPost:7174090132512260096)
* [Seventh Annual Janice Pogue Lectureship in Biostatistics](https://www.phri.ca/lectureships/), Population Health Research Institute, Hamilton, Ontario, Canada 2024-12-05
* [Slides](https://hbiostat.org/talks/rcteff.html)
* [Pictures](https://www.linkedin.com/feed/update/urn%3Ali%3Aactivity%3A7271161538067992576/?midToken=AQHdxkrKc00ieg&midSig=2-vwKVisN9TXw1)
* [Video](https://lnkd.in/gnaSDUGw)

#### Important Considerations in Trial Design for Flexibility & Efficiency
* RRE 2026: Research RoundTable in Epilepsy, Washington DC 2026-04-30
* Shortened version with outcome examples for epilepsy trials
* [Slides](https://hbiostat.org/talks/rcteff2.html)