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Episode 56, “A Visit with Byron Gajewski: KUMC, Innovative Trial Designs, the HOBIT Trial”
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In this episode of "In the Interim…", Dr. Scott Berry connects with Dr. Byron Gajewski, professor of biostatistics and data science at the University of Kansas Medical Center (KUMC), for a detailed discussion on the design, simulation, and operational realities of Bayesian adaptive clinical trials in academic environments.
In Episode 56 of "In the Interim…", Dr. Scott Berry sits down with Dr. Byron Gajewski, professor at University of Kansas Medical Center, to discuss the HOBIT trial, a groundbreaking Bayesian adaptive platform investigating hyperbaric oxygen treatment for severe traumatic brain injury.
The HOBIT trial employs an innovative design driven by the complexity of the application: eight treatment arms, response adaptive randomization, group sequential features, and sliding dichotomy endpoints. With no established treatments for severe TBI, this Phase 2 trial uses adaptive methods to efficiently explore multiple hyperbaric oxygen pressure levels and treatment combinations.
Byron shares insights on building adaptive trial infrastructure in academic medicine, the power of Bayesian interpretation over binary yes/no outcomes and training the next generation of adaptive trial designers. His team at KUMC demonstrates how simulation-driven design and rigorous implementation can tackle complex clinical questions.
Listen to the full conversation today: https://www.berryconsultants.com/resource/56-a-visit-with-byron-gajewski-kumc-innovative-trial-designs-the-hobit-trial
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Episode 58, “ICH-E20, Regulators, and False Choices”
In this episode of "In the Interim…", host Dr. Scott Berry undertakes a detailed, methodical critique of ICH-E20 draft guidance language as applied to adaptive clinical trial design.
Episode 57, “PANTHER: A Phase 2 International Platform Trial in ARDS”
In this episode of "In the Interim…" Dr. Scott Berry is joined by Professors Victoria Cornelius, Danny McAuley, and Anthony Gordon, for a technical review of the PANTHER trial—an international, Phase 2 adaptive platform evaluating pharmacologic interventions for ARDS.
Episode 56, “A Visit with Byron Gajewski: KUMC, Innovative Trial Designs, the HOBIT Trial”
In this episode of "In the Interim…", Dr. Scott Berry connects with Dr. Byron Gajewski, professor of biostatistics and data science at the University of Kansas Medical Center (KUMC), for a detailed discussion on the design, simulation, and operational realities of Bayesian adaptive clinical trials in academic environments.
Episode 55, “A Visit with Stephen Senn: Time, Concurrent Controls, and the Bayesian Guidance”
In this episode of "In the Interim...", Dr. Scott Berry hosts Dr. Stephen Senn, award-winning statistician and author, for a discussion on advanced challenges in adaptive and platform trial methodology.
Episode 54, “Making Sense of Hierarchical Composites”
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Episode 50, “The Fallacy of Ordinal Endpoints”
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Episode 53, “The SNAP Trial with Professors Tong and Davis”
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Blog released on “Enhancing Phase 3 Trials Through Bayesian Borrowing”
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Episode 51, “The Art of Storytelling with Shaun Cassidy”
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Blog released on “Technical Realities of Ordinal Endpoint Analysis in Clinical Trials”
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Episode 48, “Platform Trial in Orthopaedic Surgery”
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Episode 47, “A Visit with Michael Harhay”
In this episode of "In the Interim…", Dr. Scott Berry speaks with Dr. Michael Harhay, Associate Professor at the University of Pennsylvania and Director of the Center for Clinical Trials Innovation.
Blog released on “Guide to the Draft FDA Bayesian Guidance 2026”
The FDA Draft Bayesian guidance is a dramatic leap forward for Bayesian clinical trials and regulatory science. In this blog, Dr. Kert Viele outlines the key concepts and motivations for the guidance recommendations.
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Episode 45, “Path 2 Parkinson’s Prevention with Drs. Simuni and Wendelberger”
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FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
Today, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials.
Episode 44, “Statistical Communication”
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Episode 43, “The Rumor of One Trial for Substantial Evidence”
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Episode 42, “Communication for Scientists: A Discussion with Jenny Devenport
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Episode 41, “Navigating the Arena: Platform Trials”
In this episode of "In the Interim…", Dr. Scott Berry delivers a metaphoric critique of single-question trial infrastructure through the sports arena analogy, illustrating the cost, patient burden, and data inefficiency of conventional clinical trials.
Episode 40, “Jumping Hurdles: Interim Analyses for Funding Decisions”
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Episode 39, “Discussion with Kaspar Rufibach”
In this episode of "In the Interim...", Dr. Scott Berry interviews Dr. Kaspar Rufibach, Co-Head of Advanced Biostatistical Sciences at Merck.
Episode 38, “Bayesian Statistics in Clinical Trials: The Past, Present, and Future”
In this episode of "In the Interim…" guest host Cooper Berry moderates a detailed discussion on the evolution and practice of Bayesian methodology in clinical trials with fellow family members Dr. Don Berry, Dr. Scott Berry, Dr. Lindsay Berry, and Dr. Nick Berry.
Episode 37, “A Visit with Stroke Neurologist Dr. Jeff Saver”
In episode 37 of "In the Interim…", Dr. Jeff Saver, Director of the UCLA Comprehensive Stroke and Vascular Neurology Program, details his shift from behavioral neurology to clinical stroke research after early engagement with multicenter trials like TOAST.
Episode 36, “The Saga of the Lecanemab Adaptive Phase II Trial”
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Episode 35, “Teaching Statistics and Data Science through Sports”
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Episode 34, “Digital Googols”
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Berry Consultants Releases FACTS 8
FACTS 8, the newest version of Berry Consultants’ Fixed and Adaptive Clinical Trial Simulator, introduces support for Ordinal endpoints and a new Quick Start feature.
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Episode 26, “Discussions on the ICH E20 Draft Guidance”
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Episode 27, “The Mystery of Clinical Trial Simulation”
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Episode 29, “Bayesian Clinical Trials with Frank Harrell”
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Episode 30, “A Visit with Dr. Janet Wittes”
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Episode 31, “The Not So Promising Zone Design”
In this episode of "In the Interim…", Dr. Scott Berry examines the mathematical foundations and efficiency claims of the promising zone design for adaptive sample size in clinical trials.
Episode 32, “Moving Clinical Trial Goalposts”
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele analyze how regulatory, editorial, and science community standards often impose additional, inconsistent requirements for novel methods in clinical trial design, rarely applied to standard approaches.
FACTS Webinar Series – Simulation Guided Trial Design Using FACTS
Berry Consultants is pleased to announce a complimentary 10-part webinar series focused on simulation guided trial design using FACTS software to be held October through December 2025.
2025 RISW in Bethesda, MD
Berry Consultants is proud to sponsor and attend the 2025 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop (RISW), taking place September 24–26 in Bethesda, MD.
Episode 19, “The STEP Platform with Dr. Eva Mistry and Dr. Jordan Elm”
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Episode 20, “The Legend of I-SPY 2 - Part A”
In Episode 20 of Berry’s "In the Interim..." Podcast, The Legend of I-SPY 2 - Part A, Dr. Don Berry and Dr. Scott Berry discuss the origins and design of the I-SPY trials.
Episode 21, “The Legend of I-SPY 2 - Part B”
In this episode, Dr. Don Berry and Dr. Scott Berry provide an in-depth account of I-SPY 2, focusing on the trial’s use of the “time machine” methodology—an Bayesian solution allowing bridging across arms to inform ongoing analyses.
Episode 22, “The Time Machine”
Dr. Scott Berry and Dr. Kert Viele discuss the origins and implementation of the “time machine” modeling approach, beginning with sports analytics and progressing to adaptive platform clinical trials.
Episode 23, “Bayesian Approach in Clinical Trials”
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Episode 24, “STEP Statistical Modeling”
In this episode of "In the Interim…", Dr. Scott Berry, Dr. Elizabeth Lorenzi, and Dr. Amy Crawford discuss the STEP platform trial’s statistical methodology for evaluating which acute stroke patients benefit and which do not from endovascular therapy (EVT).
Episode 25, “A Discussion with Michael Proschan on Response-Adaptive Randomization”
In this episode of "In the Interim…", Dr. Scott Berry and NIH’s Dr. Michael Proschan conduct a detailed discussion from opposing viewpoints on response-adaptive randomization (RAR) in clinical trials.
New Publication: Dr. Donald Berry on the Evolution of Bayesian Clinical Trials
Dr. Donald Berry has published a comprehensive history from his perspective on the development of Bayesian clinical trials, entitled “Adaptive Bayesian Clinical Trials: The Past, Present, and Future of Clinical Research.” It’s available free with open access from the publisher at https://www.mdpi.com/2077-0383/14/15/5267
2025 JSM in Nashville, Tennessee
Berry Consultants is proud to sponsor next week’s American Statistical Association 2025 Joint Statistical Meetings (JSM) in Nashville, Tennessee!
Episode 11, “Implementing Adaptive Trials"
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Episode 12, “Platform Trial in Psychiatry with Dr. Husseini Manji"
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Episode 13, “DSMBs in Adaptive Trials with Roger Lewis"
In this episode of "In the Interim…", host Dr. Scott Berry is true to the name of the podcast, as he discusses the unblinded world of adaptive clinical trials alongside Dr. Roger Lewis, a renowned expert in both statistical science and clinical medicine.
Episode 14, “Drug Developers’ Lessons from Sports: Regression-to-the-Mean"
In this engaging episode of "In the Interim...", host Dr. Scott Berry is joined by Dr. Nick Berry to explore the intriguing parallels between sports and drug development, focusing on the concept of "regression-to-the-mean."
Episode 15, “Prof Craig Ritchie: Looking Back at EPAD, Moving Forward in Alzheimer’s Disease"
Scott Berry, Founder of Berry Consultants, interviews Professor Craig Ritchie—specialist in brain health and neurodegenerative diseases, Chief Investigator of EPAD (European Prevention of Alzheimer Dementia), and CEO of Scottish Brain Sciences—for a precise analysis of platform trial methodology in Alzheimer’s research.
Episode 16, “Spending Alpha"
In this solo episode of "In the Interim...", Scott Berry, President and Senior Statistical Scientist at Berry Consultants, addresses deep-rooted confusion in the field of adaptive clinical trial design surrounding the concept of “spending alpha.”
Episode 17, “Seamless 2/3 Trial Designs"
Scott Berry convenes co-authors Kert Viele, Joe Marion, and Lindsay Berry to discuss the statistical and developmental nuances of inferentially seamless phase 2/3 clinical trial designs.
Episode 18, “A Statistician Reads JAMA"
Dr. Scott Berry applies a statistician’s review of a random trial result published in JAMA – the FAIR-HF2 clinical trial. Interrogating the frequentist paradigm and the focus on the binary outcome of the primary hypothesis test.
FACTS 7.2 Release
Berry Consultants is excited to announce the release of version 7.2 of FACTS (Fixed and Adaptive Clinical Trial Simulator) today, which now includes a broader set of dose escalation designs.
Episode 10, “Revisiting Seamless 2/3 Trial for GLP-1 Agonist"
In this episode of "In the Interim..." we revisit the ground-breaking seamless phase 2/3 clinical trial for the GLP-1 agonist, dulaglutide—better known as Trulicity.
Episode 9, “I-SPY 2 to GMB AGILE and Beyond"
In this episode of "In the Interim...," we sit down with Dr. Meredith Buxton to explore the evolution of platform trials from I-SPY 2 to GBM AGILE and Beyond.
Today’s episode, “External Data in Clinical Trials"
In this episode of "In the Interim...," Scott Berry and Kert Viele navigate the nuanced debate surrounding the integration of external data in clinical trials.
Episode 7, “Remembering Jimmie Savage"
In today's podcast episode, discover more about Jimmie Savage—the man who shaped Bayesian statistics and left an indelible mark on the field.
Today’s Episode, “The Art and Slog of Innovating"
This week Dr. Michael Krams joins the podcast to discuss the art and slog of innovation in pharmaceutical companies and clinical trials.
Episode 5 released today, "Religion, Politics, and Ordinal Outcomes"
In this latest episode of our podcast, Scott Berry discusses the controversial and vital topic of ordinal outcomes.
Episode 4, "HEALEY ALS Platform Trial with Dr. Merit Cudkowicz and Dr. Melanie Quintana"
Join us for an exploration into the HEALEY ALS Platform Trial, a pioneering effort in adaptive trial design, with Dr. Merit Cudkowicz of MGH and Dr. Melanie Quintana from Berry in today's podcast.
Episode 3, "FACTS 7.1 Release with Tom Parke" is now available!
Our latest podcast episode explores the fascinating world of clinical trial simulation, spotlighting updates to FACTS 7.1!
Podcast Episode 2, "When Should You Use Adaptive Design Clinical Trials?" is live!
Join President, Dr. Scott Berry, and Director of Research, Dr. Kert Viele, as they unravel the nuances of adaptive design in clinical trials.
Berry Releases New Podcast Series, “In the Interim…”
In 2025 Berry will be celebrating 25 groundbreaking years in the field of statistical and adaptive clinical trials, and today we're excited to announce the launch of Berry's "In the Interim..." podcast.
February 2025 FACTS Webinar
This month’s webinar will be on the topic, “Why simulate? Can clinical trial simulation really improve the strategic decision making in drug development?”
Mike Krams, M.D. joins the Berry Consultants Team
Berry Consultants has hired Dr. Mike Krams as a Senior Medical Scientist in Europe, bringing extensive experience in clinical development strategy and adaptive trials to the team.
FACTS 7.1 Release
Berry Consultants has released FACTS 7.1, featuring enhancements such as concurrent control comparisons, conditional power calculations, new analysis options for dichotomous endpoints, integration with the R package "Airship" for flexible graphing, improved Bayesian dose escalation consistency, and various interface improvements.
FACTS Webinar Series in Oct. and Nov.
Berry Consultants is hosting a free 6-week public webinar series on "Case Studies in using FACTS to design Clinical Trials" from October 17th to November 21st, 2024, featuring live demonstrations of trial design using their simulation software, with registration available for each session at their website.
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
Berry Consultants is proud to be a Principal Sponsor of the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Rockville, MD from September 25th-27th, and invites attendees to visit their exhibit booth to discover their trial design, implementation, and software solutions.
External Podcast: Innovative Clinical Trial Design Identifies Effective Drug and Its Most Efficacious Dose for Treating Early Alzheimer Disease
In the September 6, 2024 episode of SciPod Health and Medicine, the podcast discusses a paper on Lecanemab for early Alzheimer’s disease by Dr.
August 2024 FACTS Webinar
Join us on August 23rd at 11am EDT for a public webinar led by FACTS developer Elias Meyer, focusing on interactive results exploration and visualization using the R Shiny App AIRSHIP; register in advance at the provided Zoom link.
ASA JSM 2024
Berry Consultants will sponsor the ASA JSM next week, inviting attendees to visit booth #101 for insights on adaptive clinical trial design, software demos, and to catch Dr. Joseph Marion's presentation on innovative clinical trial solutions for pediatric neurodevelopmental disorders on August 4.
July 2024 FACTS Webinar
Join the Berry Consultants software team on July 26 at 11am EDT for a public webinar exploring the open enrollment option in the FACTS Dose Escalation N-CRM module, including its functionality, benefits, and comparison to the BOIN "backfill" option; register in advance at the provided Zoom link.
PSI: Statisticians in the Pharmaceutical Industry Conference
Berry Consultants will sponsor and present at the PSI Conference in Amsterdam from June 16-19, featuring team members who will discuss various topics related to adaptive designs and clinical trials; visit booth #12 to learn more about their consulting and software solutions.
Summer Biometric Seminar of the Viennese Section of the International Biometric Society
The Berry Consultants team is thrilled to present at the free Summer Biometric Seminar on June 21st at the Medical University of Vienna, focusing on "Bridging the Gap between Bayesian & Frequentist Approaches in Clinical Trials for Drug Development," with options to attend in person or online via WebEx.
June 2024 FACTS Webinar
Join the June 14th FACTS Software Webinar at 11am EDT for an exclusive preview of the new features in the upcoming FACTS 7.1 release, including enhanced simulators, new statistical analyses, improved graphing capabilities, and user-friendly tooltips—register in advance at the provided Zoom link.
45th Annual Meeting of the Society for Clinical Trials
The Berry Consultants team is eager to present at the 45th Annual Meeting of the Society for Clinical Trials in Boston, MA, with sessions on patient-centered trial design, predictive probabilities, and the HEALEY ALS Platform Trial scheduled for May 21st and 22nd.
April 2024 FACTS Webinar
Join the Berry Consultants Software team for an April 26 webinar at 11am EDT, where they will showcase an optimization project focused on automated design evaluation and extracting early stopping boundaries for adaptive designs; register here: https://us02web.zoom.us/webinar/register/WN_mAEuXVOATGqJE44JSrMu2w.
March 2024 FACTS Webinar
Join the FACTS Software March Webinar on March 22 at 11am EDT to explore Response Adaptive Randomization (RAR) through practical insights, misconceptions, and simulated examples in R and FACTS—register now!
Berry Consultants Releases New Version of ADDPLAN
The Berry Consultants Software team has released ADDPLAN NEO version 10.2, which introduces new features including a graph for Group Sequential designs, stopping boundaries, interim test statistic estimates from simulated trials, and illustrative examples to enhance understanding for non-statisticians.
International Society for Biopharmaceutical Statistics Symposium March 6th-9th
Berry Consultants will present at the ISBS Symposium this week, featuring Dr. Christina Saunders on March 8th at 2pm EST and Dr. Kert Viele on March 9th at 1:30pm EST, with details available at the ISBS program link.
2024 ENAR Spring Meeting March 10th-13th
Berry Consultants will present two topics at the 2024 ENAR Spring Meeting on March 11, featuring Joe Marion, Ph.D., discussing "Borrowing Phase 2 Data in Phase 3" at 9:20am EST, and Amy Crawford, Ph.D., presenting on "Identifying Patients Who Benefit from EVT" at 10:55am EST.
February 2024 QUOTES Webinar
Berry Consultants will host a free webinar on February 23 at 11:00 AM EST, focusing on optimizing clinical trial design and estimating the expected net present value of drug development programs using the QUOTES software, particularly addressing the trade-offs in phase 2 trials.
January 2024 FACTS Webinar
Join the Berry Consultants software team for their January FACTS webinar on January 19th at 11am EST to learn about the upcoming addition of an ordinal endpoint option to the trial simulator via Zoom at the provided link.
ASA Women in Statistics and Data Science Conference 2023
Join Dr. Cora Allen-Savietta from Berry Consultants on October 25 for a presentation on a platform trial in Parkinson's disease.
New Public Webinar Series: Introduction to Adaptive Trial Designs using FACTS
Public live Zoom webinars on "Introduction to Adaptive Trial Designs using FACTS" are scheduled for October and November.
ASA Biopharmaceutical Industry Statistics Workshop
Berry Consultants is sponsoring the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop from September 27-29 in Rockville, MD, where several team members will be presenting, and attendees can find more information and register on the ASA Workshop Website.
Futility in Clinical Trials
The new JAMA Guide to Statistics and Methods by Dr. Barbara Wendelberger and Dr. Roger Lewis examines the concept of futility in clinical trials.
PSI 2023 Conference June 11-June 14
Visit the Berry Consultants booth to meet our team and experience demos of our latest software products: FACTS 7, ADDPLAN, and QUOTES.
44th Annual SCT Meeting
The Berry Consultants team will present sessions on May 22 at 2:45 PM EST and May 23 at 4:15 PM EST.
FDA/AdvaMed Medical Device Statistical Issues Conference
On May 12, Dr. Amy Crawford and Dr. Joe Marion from Berry Consultants will present at the FDA/AdvaMed Conference.
Applied Probability Conference
Peter Jacko will present "Bandit Procedures for Designing Patient-Centric Clinical Trials" on April 21.
Berry Consultants Releases FACTS 7 Clinical Trial Simulator
FACTS 7 introduces a new module specifically for Platform Trial designs.
Advanced Statistical Methods to Borrow External Information
Dr. Ben Saville will present at the DIA/FDA Biostatistics Industry & Regulator Forum on March 30.
JAMA releases paper on Lecanemab for Patients With Early Alzheimer Disease
The study employs Bayesian analysis to evaluate dose-finding in a Phase 2b randomized clinical trial.
Adaptive Designs and Multiple Testing Procedures Workshop
Join Tom Parke for the ADMTP 2023 Workshop in Basel, Switzerland.