Blog released on “Enhancing Phase 3 Trials Through Bayesian Borrowing”

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Lindsay Berry investigate the statistical foundations and clinical implications of analyzing ordinal endpoints, drawing on experience from major stroke and COVID-19 trials. Discussion centers on the Modified Rankin Scale, DAWN, MR CLEAN, and REMAP-CAP.

In this episode of "In the Interim…", Dr. Scott Berry interviews Professors Steven Tong and Josh Davis about the SNAP platform trial for Staphylococcus aureus bacteremia. The discussion covers SNAP’s rationale, large-scale adaptive design, methodology, and operational execution at approximately 150 hospitals in 13 countries.

Bayesian borrowing in Phase 3 trials formally combines prior evidence with the new trial data to enhance development efficiency and regulatory decision making. This approach requires rigorous statistical modeling, careful selection of historical information, and detailed regulatory dialogue.

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele examine Bayesian borrowing in Phase 3 clinical trials, focusing on statistical handling of prior information and real-world FDA interactions.

In Episode 51 of "In the Interim…", Dr. Scott Berry interviews writer, producer, and performer Shaun Cassidy to examine the practical elements of storytelling that matter in scientific and statistical communication.

A rigorous review of ordinal endpoint analyses, showing every approach—utility weighting, proportional odds, dichotomization, or non-parametric—inevitably assigns relative weights to outcome states. Berry Consultants’ mathematical demonstration reveals how proportional odds analysis embeds prevalence-based weights, underscoring the need for transparency and clinical input in trial design.

In this episode of "In the Interim…", Dr. Scott Berry marks the podcast’s one-year anniversary, sharing listener metrics, watch data, and regional engagement. He then delivers a step-by-step analysis of the FDA meeting process, detailing the progression from initial sponsor meeting requests and question submission to briefing book preparation, feedback cycles, and in-person logistics.

Dr. Nathan O’Hara (University of Maryland), Dr. Gerard Slobogean (UC Irvine), and Dr. Sheila Sprague (McMaster University) describe the launch and design of the Musculoskeletal Adaptive Platform Trial (MAPT)—the first major adaptive platform trial in orthopaedic surgery.

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.

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.

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele deliver a quick reaction to the FDA’s draft guidance on Bayesian statistics for clinical trials of drugs and biologics.

In this episode of "In the Interim…", Dr. Scott Berry is joined by Dr. Tanya Simuni, Arthur C. Nielsen Jr. Professor of Neurology and Director of the Parkinson’s Disease and Movement Disorders Center at Northwestern University, and Dr. Barbara Wendelberger, Senior Statistical Scientist at Berry Consultants.

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.

In this episode of “In the Interim…,” host Dr. Scott Berry examines the challenge of communicating complex statistical concepts to non-statistical audiences.

In this episode of "In the Interim…", host Dr. Scott Berry and frequent co-host Dr. Kert Viele, Senior Statistical Scientist at Berry Consultants, analyze the potential shift in FDA regulatory policy from requiring two independent trials to accepting a single trial as sufficient for “substantial evidence” in drug approvals.

In this episode of "In the Interim…", Dr. Jenny Devenport, Global Head of Methods, Collaboration, and Outreach at Roche, joins Dr. Scott Berry for a detailed discussion on career evolution, statistical culture, and communication in the pharmaceutical industry.

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.

In episode 40 of "In the Interim…", Dr. Scott Berry examines the statistical, operational, and behavioral challenges of using interim analyses as triggers for funding in adaptive and seamless Phase II/III clinical trials.

In this episode of "In the Interim...", Dr. Scott Berry interviews Dr. Kaspar Rufibach, Co-Head of Advanced Biostatistical Sciences at Merck.

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.

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.

In Episode 36 of "In the Interim…", Dr. Scott Berry and Dr. Don Berry analyze the Phase II trial of Lecanemab (BAN2401) in Alzheimer’s disease, focusing on the application of adaptive Bayesian methods following persistent failures in Alzheimer’s drug development.

On this episode of “In the Interim…”, which is co-sponsored by the Journal of Statistics and Data Science Education, Dr. Scott Berry talks with Dr. Jim Albert, Professor Emeritus at Bowling Green State University, whose extensive work encompasses Bayesian statistics and computation, sports analytics, and decades of exemplary teaching.

In this episode of "In the Interim…", Dr. Scott Berry examines the concept of “digital twins” in clinical trials. He details how simulation of clinical trials is a direct analog of digital twin methodology, allowing for the in-silico modeling of the physical trial conduct, enrollment, dropouts, and patient outcomes under varied assumptions.

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.

In this episode of "In the Interim…", Dr. Scott Berry interviews Dr. Andrew Thomson, owner and lead consultant of Regnitio.

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele review the ICH E20 draft guidance on adaptive clinical trial designs, offering a technical yet accessible breakdown for trial sponsors, practitioners, and those interested in clinical development.

Dr. Scott Berry hosts this episode of "In the Interim…", opening with statistical analysis of elite athletes before focusing on the misunderstood role of clinical trial simulation.

In this episode of "In the Interim…", Dr. Scott Berry interviews Dr. Derek Angus, Distinguished Professor and Chair of Critical Care Medicine at the University of Pittsburgh and senior editor at JAMA.

In this episode of "In the Interim…", Dr. Scott Berry chats with Frank Harrell, a professor of Biostatistics at Vanderbilt University and W.J. Dixon Award winner. Harrell describes his transition from frequentist to Bayesian clinical trial design, prompted by a decisive meeting with Dr. Don Berry, informed by David Spiegelhalter’s published work.

Episode 30 of “In the Interim…” features Dr. Janet Wittes, Fellow of the American Statistical Association, past president of the Society of Clinical Trials, and founder of Statistics Collaborative, in discussion with Dr. Scott Berry.

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.

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.

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.

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.

This episode of "In the Interim..." features an in-depth discussion of the StrokeNet Thrombectomy Endovascular Platform (STEP), a multi-domain, adaptive platform trial for acute stroke, anchored in the NIH StrokeNet network.

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.

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.

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.

This episode of "In the Interim…" features Dr. Scott Berry, Dr. Kert Viele, and Dr. Melanie Quintana of Berry Consultants dissecting the technical and operational landscape of Bayesian statistics in clinical trial design.

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).

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.

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

Berry Consultants is proud to sponsor next week’s American Statistical Association 2025 Joint Statistical Meetings (JSM) in Nashville, Tennessee!

In Episode 11 of "In the Interim...", host Scott Berry discusses the nuances of implementing adaptive clinical trials with Dr. Anna McGlothlin and Dr. Michelle Detry from Berry Consultants.

In the latest episode of "In the Interim...", Dr. Scott Berry and Dr. Mike Krams sit down with Dr. Husseini Manji, to explore the potential of platform trials in advancing precision medicine within psychiatry, particularly in tackling complex mental illnesses.

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.

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."

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.

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.”

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.

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.

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.

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.

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.

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.

In today's podcast episode, discover more about Jimmie Savage—the man who shaped Bayesian statistics and left an indelible mark on the field.

This week Dr. Michael Krams joins the podcast to discuss the art and slog of innovation in pharmaceutical companies and clinical trials.

In this latest episode of our podcast, Scott Berry discusses the controversial and vital topic of ordinal outcomes.

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.

Our latest podcast episode explores the fascinating world of clinical trial simulation, spotlighting updates to FACTS 7.1!

Join President, Dr. Scott Berry, and Director of Research, Dr. Kert Viele, as they unravel the nuances of adaptive design in clinical trials.

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.

This month’s webinar will be on the topic, “Why simulate? Can clinical trial simulation really improve the strategic decision making in drug development?”

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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!

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.

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.

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.

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.

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.

Join Dr. Cora Allen-Savietta from Berry Consultants on October 25 for a presentation on a platform trial in Parkinson's disease.

Public live Zoom webinars on "Introduction to Adaptive Trial Designs using FACTS" are scheduled for October and November.

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.

The new JAMA Guide to Statistics and Methods by Dr. Barbara Wendelberger and Dr. Roger Lewis examines the concept of futility in clinical trials.

Visit the Berry Consultants booth to meet our team and experience demos of our latest software products: FACTS 7, ADDPLAN, and QUOTES.

The Berry Consultants team will present sessions on May 22 at 2:45 PM EST and May 23 at 4:15 PM EST.

On May 12, Dr. Amy Crawford and Dr. Joe Marion from Berry Consultants will present at the FDA/AdvaMed Conference.

Peter Jacko will present "Bandit Procedures for Designing Patient-Centric Clinical Trials" on April 21.

FACTS 7 introduces a new module specifically for Platform Trial designs.

Dr. Ben Saville will present at the DIA/FDA Biostatistics Industry & Regulator Forum on March 30.

The study employs Bayesian analysis to evaluate dose-finding in a Phase 2b randomized clinical trial.

Join Tom Parke for the ADMTP 2023 Workshop in Basel, Switzerland.

Register now to attend Dr. Melanie Quintana's presentation at the DIA/FDA Biostatistics Industry & Regulator Forum on March 29.

Dr. Melanie Quintana will be presenting at the MDA Clinical & Scientific Conference on March 21 at 4:30 PM CT.

Dr. Ben Saville of Berry Consultants will explore essential elements of the ENRICH randomized adaptive clinical trial.

The partnership between Berry Consultants and the NIH on the ALS Innovative Research Initiative is a remarkable endeavor aimed at advancing research in ALS.

Berry Consultants will sponsor and present at the virtual American Statistical Association's Joint Statistical Meetings from August 2-6, 2020, with more details available on the JSM website.