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April 15, 2025
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Why Simulate?
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Mike Krams, M.D.
Senior Medical Scientist
In this FACTS Webinar, Dr. Mike Krams of Berry Consultants hosts a panel of experts to discuss, “Why Simulate?”
In this FACTS Webinar, Dr. Mike Krams of Berry Consultants hosts a panel of experts to discuss, “Why Simulate?” The conversation focuses on how to enhance strategic decision making in drug development through simulation guided clinical trial design. The panel includes:
- Dr. Andy Grieve (King’s College London)
- Dr. Tobias Mielke (Janssen)
- Dr. Inna Perevozskaya (BMS)
- Dr. Kert Viele (Berry Consultants)
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Why Simulate?
In this FACTS Webinar, Dr. Mike Krams of Berry Consultants hosts a panel of experts to discuss, “Why Simulate?”
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April 15, 2025
JAMA Podcast Series: Evaluating Treatments for Amyotrophic Lateral Sclerosis
Author Sabrina Paganoni, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, discusses results of the first 4 drug regimens from the HEALEY ALS platform trial and how this study design makes efficient use of resources.
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February 17, 2025
President’s Council of Advisors on Science and Technology (PCAST)
Don Berry presents as part of a panel of Researchers on the topic of “Improving Scientific Reproducibility in an Age of International Competition and Big Data I” at the PCAST Public Meeting on January 31, 2014.
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January 31, 2014
JAMA evidence Podcast Series: Bayesian Analysis, Using Prior Information
Roger J. Lewis, MD, PhD, discussed Bayesian Analysis: Using Prior Information to Interpret the Results of Clinical Trials with Melanie Quintana, PhD.
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September 2, 2021
GBM AGILE Trial: How does GBM AGILE work?
Global Coalition for Adaptive Research released a series of Spotlight short videos presented by Don Berry on the GBM AGILE Trial.
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August 11, 2021
JAMAevidence Podcast Series: Bayes for Clinicians Who Need to Know but Don’t Like Math with Dr. Anna McGlothlin
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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December 18, 2018
JAMAevidence Podcast Series: JAMA Guide to Statistics and Methods with Dr. Roger Lewis
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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December 5, 2019
JAMAevidence Podcast Series: Minimal Clinically Important Difference: Defining What Really Matters to Patients with Dr. Anna McGlothlin
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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August 6, 2020
JAMAevidence Podcast Series: Randomization in Clinical Trials with Dr. Roger Lewis
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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December 3, 2020
JAMAevidence Podcast Series: Logistic Regression: What It Is and How to Use It in Clinical Research with Dr. William Meurer and Dr. Juliana Tolles
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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January 7, 2021
JAMAevidence Podcast Series: Bayesian Analysis: Using Prior Information to Interpret the Results of Clinical Trials with Dr. Melanie Quintana
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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September 2, 2021
JAMAevidence Podcast Series: Time-to-Event Analysis with Dr. Juliana Tolles
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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March 3, 2023
JAMAevidence Podcast Series: Bayesian Hierarchical Models with Dr. Anna McGlothlin
This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.
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July 3, 2024
SciPod Podcast Series: Innovative Clinical Trial Design Identifies Effective Drug and Its Most Efficacious Dose for Treating Early Alzheimer Disease
In this September 6, 2024 episode by SciPod Health and Medicine, SciPod summarizes the recent paper “Lecanemab for Patients with Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial” by Dr. Donald Berry (Founder of Berry Consultants) and Scott Berry (President of Berry Consultants).
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September 6, 2024
Case Studies in using FACTS to design Clinical Trials: A 2-arm MACE safety study
Using FACTS to design a large 2-arm safety study, borrowing information from a previous trial, exploring alternative endpoints and using an enriched population.
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November 21, 2024
Case Studies in using FACTS to design Clinical Trials: An Alzheimer’s Phase 2 dose finding study
A Phase 2 dose finding study using a Bayesian dose response model and response adaptive randomization across multiple doses and treatment regimens. Includes a presentation of the interim analyses from the actual trial that lead to the successful phase 3 trial of Lecanemab.
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November 14, 2024
Case Studies in using FACTS to design Clinical Trials: A trial in hemorrhagic stroke with adaptive enrichment
A randomized two arm study, using a utility weighted modified Rankin score and rules for adapting the enrolment criteria based on the location of the haemorrhage.
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November 7, 2024
Case Studies in using FACTS to design Clinical Trials: An open enrollment CRM dose escalation study
Designing a phase 1 dose escalation using Bayesian Logistic Regression Model (BLRM), with open enrolment (rather than cohort) using FACTS N-CRM.
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October 31, 2024
Case Studies in using FACTS to design Clinical Trials: A two-arm study with adherence model driven effect size and irregular interim analyses
Using FACTS to design a two-arm study where differences in adherence between the arms drive the effect size. Uncertainty in the effect size prompted spacing the interims to correspond to different sample sizes resulting in irregular interim analyses. Using a uses a finite mixture model from previous data on the analysis endpoint to justify the irregular interims.
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October 24, 2024
Case Studies in using FACTS to design Clinical Trials: A Seamless Phase 2/3 multiple endpoint diabetes trial
Is this the most complex and most successful trial ever designed and run? Looking at the AWARD 5 trial for what became Eli Lilly’s Trulicity drug. The drug used response adaptive randomization, longitudinal modelling, dose response modelling and a utility function combining 4 endpoints. The trial selected a successful dose and switched early from phase 2 to a successful phase 3.
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October 17, 2024
The Biomarkers Consortium: I-SPY 2 Press Conference
Don Berry speaks as part of the press conference for I-SPY 2, an innovative breast cancer clinical trial.
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March 17, 2020
Slowly but surely, Bayesian Ideas revolutionize medical research
Don Berry at the 2012 International Society for Bayesian Analysis (ISBA) World Meeting in Kyoto, Japan. https://videolectures.net/videos/isba2012_berry_bayesian_ideas
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August 22, 2012
A Fully Bayesian World: What a Wonderful World
Scott Berry presents at the Royal Statistical Society’s, “PSI Debate: This house believes that pharmaceutical drug development and regulation should become fully Bayesian”.
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October 26, 2012
The Design of Complex Adaptive Trials
Scott Berry presents at the “Transforming Drug Development – Delivering Innovation and Efficiency through Adaptive Clinical Trials” conference that was co-sponsored by Berry Consultants.
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March 20, 2013
Introducing Decision-Making Under Uncertainty to Medical Research: Designing More Efficient and More Accurate Clinical Trials
Don Berry’s presentation at the Simons Institute for the Theory of Computing at University of California Berkeley.
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September 19, 2016
Complete REMAP-CAP Video Library
https://remap-cap.org
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May 20, 2020
Sit Down with Lindsay Berry
REMAP-CAP
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August 21, 2021
Scott Berry – REMAP-CAP Current State Statistical Model
Scott Berry from Berry Consultants gives an overview of the current state statistical model for REMAP-CAP.
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June 7, 2020
Complete PREPARE Video Library
PREPARE Webinar 07/04/2021 - Why future clinical trials will be platform trials
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July 4, 2021
Why Future Clinical Trials will be Platform Trials (with Scott Berry at the 20:50 mark on “Taming the Beast”).
PREPARE Webinar 07/04/2021 - Why future clinical trials will be platform trials
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July 4, 2021
HEALEY ALS Platform Trial Launch Announcement
Learn more about this groundbreaking trial designed by Berry Consultants to accelerate the development of effective treatments for people in ALS. Weekly updates and additional videos can be found on HEALEY ALS Platform Trial Video Library of Mass General Hospital.
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August 30, 2020
The PRINCIPLE Adaptive Platform Trial for Community Treatment of COVID-19: Innovation in Trial Design and Delivery
Dr. Ben Saville of Berry Consultants and Dr. Chris Butler of Oxford University present a Grand Rounds session on the PRINCIPLE Adaptive Platform Trial.
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May 21, 2021
GBM AGILE Trial: Bringing Bayesian Statistics into Clinical Trials
Bringing Bayesian Statistics into Clinical Trials - Shortened Version
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August 30, 2021
GBM AGILE Trial: What makes GBM AGILE an innovative trial?
What makes GBM AGILE an innovative trial?
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August 11, 2021
GBM AGILE Trial: How is GBM AGILE paving the way for more innovative research?
How is GBM AGILE paving the way for more innovative research?
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August 11, 2021
GBM AGILE Trial: A Brief History of GBM AGILE
Global Coalition for Adaptive Research released a series of Spotlight short videos presented by Don Berry on the GBM AGILE Trial.
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July 21, 2021
Adaptive Platform Clinical Trials: Application to ILD
Roger J. Lewis, MD, PhD, lectured on REMAP-ILD at HCOR scientific meeting (Sao Paulo, Brazil).
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March 29, 2023
The Implementation of Platform Trials for ALS Research
Dr. Melanie Quintana, statistical scientist and director at Berry Consultants, discussed innovative clinical trial design in ALS research at the 2023 MDA conference.
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March 31, 2023
Introduction to Adaptive Trial Designs using FACTS: Platform Trials & MAMS designs
In this video we look at the different types of MAMS designs that includes Platform Trail designs. We look at the different design issues and analysis methods available for these sorts of trials. Originally aired November 9, 2023
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November 9, 2023
Introduction to Adaptive Trial Designs using FACTS: Basket Trials
In this video we look at designing Phase 2 Basket Trials where a treatment is explored in a large number of sub-groups (too many to be able to suitably power the trial in each sub-group).
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November 2, 2023
Introduction to Adaptive Trial Designs using FACTS: Seamless Phase 2/3 Trials
In this video we look at designing seamless phase 2/3 trials, where a multi-arm phase 2 transitions when it can, selecting a dose and transitioning to a confirmatory phase 3.
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October 26, 2023
Introduction to Adaptive Trial Designs using FACTS: Phase 2 Arm Dropping and RAR
In this video we look at designing response adaptive randomization (RAR) and arm dropping multi-arm phase 2 trials.
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October 19, 2023
Introduction to Adaptive Trial Designs using FACTS: Group Sequential Designs
In this video we look at designing Group Sequential trials for confirmatory phase 3 trials, where the trial includes interims to stop early for efficacy and futility.
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October 12, 2023
Introduction to Adaptive Trial Designs using FACTS: Phase 1 Dose Escalation
In this video we look at the issues around designing Phase 1 Dose Escalation trials in oncology, where the aim is to explore increasing dose levels up to a limiting rate of toxicities.
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October 5, 2023
FACTS Webinar: Response Adaptive Randomization RAR in multi arm trials aiming to select the best arm
This FACTS Webinar will address RAR: 1) A surprising amount of the literature considers just the two arm setting, when arguably the most interesting setting for this technique is the multi-arm one. 2) Present some results in favor of RAR. 3) Lastly there are still misconceptions around that RAR inflates type-1 error, where it is easy to show that the opposite can be true.
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November 6, 2024
EU-PEARL Webinar - Non-Concurrent Controls in Platform Trials
Dr. Scott Berry and Dr. Kert Viele from Berry Consultants delivered a presentation during the EU-PEARL webinar on February 24.
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February 24, 2022
Los Angeles County Predictive Modeling of the COVID-19 Pandemic
Berry Consultants released a video showcasing their support for the LA County Predictive Modeling for the COVID-19 Pandemic, which was recognized among the top achievements in quality and productivity by the County's Quality and Productivity Commission in 2021.
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September 10, 2021
First Participants Enrolled in the Groundbreaking Trial Led by the Sean M. Healey & AMG Center for ALS at Mass Genera
The Sean M. Healey & AMG Center for ALS at Mass General has successfully enrolled its first participants in a pioneering clinical trial aimed at advancing ALS research.
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August 3, 2020
Berry Consultants Webinar on SARS-COV-2 Vaccine Trials
On October 2, Berry Consultants hosted a public FACTS webinar led by Dr. Kert Viele, discussing the latest protocols and safety concerns of SARS-COV-2 vaccine trials from major pharmaceutical companies, with the recording available on their YouTube channel.
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October 5, 2020
Berry Consultants Webinar on Designing Trials for COVID-19
On April 24, Berry Consultants hosted a public FACTS webinar on COVID-19 trials, featuring presentations from various experts, with recorded sessions and additional resources available on their YouTube channel and linked articles.
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April 29, 2020
NHLBI ICTR Video released on Single Arm Trials
On October 29, 2018, Berry Consultants launched a video series featuring Dr. Anna McGlothlin discussing the benefits and challenges of single arm clinical trials, particularly in rare diseases, while encouraging viewers to explore additional resources on the ICTR website.
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November 1, 2018
Berry Consultants Releases Videos on Adaptive Designs
Berry Consultants has launched three new videos on adaptive designs, featuring experts discussing topics such as DSMBs, biomarkers, and the intersection of NCAA football and the Ebola pandemic, adding to their previously released videos on related subjects, all available on their YouTube channel.
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September 3, 2015