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Episode 26, “Discussions on the ICH E20 Draft Guidance”
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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 Kert Viele review the ICH E20 draft guidance on adaptive clinical trial designs, offering a technical yet accessible breakdown for trial sponsors, practitioners, and those interested in clinical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.
In episode 26 of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele deliver a review of the ICH E20 draft guidance on adaptive clinical trial designs.
They highlight the ICH E20’s formal international “acceptance” of adaptive, Bayesian, seamless, and enrichment methodologies for confirmatory trials, setting a harmonized regulatory standard. The episode points to strengths in operational guidance—simulation strategy, blinding, adaptive design reports, and type 1 error assessment. However, the language still introduces pejorative caution, awkward statements about seamless designs, and tying Bayesian methods with additional external data concepts.
Both Scott and Kert congratulate the team responsible for the draft guidance document and Berry Consultants is looking forward to submitting formal comments.
What do you think about the ICH E20 draft guidance?
Tune in for our full conversation: https://www.berryconsultants.com/resource/26-discussions-on-the-ich-e-20-draft-guidance
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Episode 26, “Discussions on the ICH E20 Draft Guidance”
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 Kert Viele review the ICH E20 draft guidance on adaptive clinical trial designs, offering a technical yet accessible breakdown for trial sponsors, practitioners, and those interested in clinical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.
Episode 27, “The Mystery of Clinical Trial Simulation”
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Episode 29, “Bayesian Clinical Trials with Frank Harrell”
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, “A Visit with Dr. Janet Wittes”
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Episode 32, “Moving Clinical Trial Goalposts”
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FACTS Webinar Series – Simulation Guided Trial Design Using FACTS
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2025 JSM in Nashville, Tennessee
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Episode 15, “Prof Craig Ritchie: Looking Back at EPAD, Moving Forward in Alzheimer’s Disease"
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Episode 16, “Spending Alpha"
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Episode 18, “A Statistician Reads JAMA"
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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"
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Today’s episode, “External Data in Clinical Trials"
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Episode 7, “Remembering Jimmie Savage"
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Episode 4, "HEALEY ALS Platform Trial with Dr. Merit Cudkowicz and Dr. Melanie Quintana"
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February 2025 FACTS Webinar
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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.
Complex Innovative Trials Designs: Current Perspectives & Future Directions
Register now to attend Dr. Melanie Quintana's presentation at the DIA/FDA Biostatistics Industry & Regulator Forum on March 29.
Accelerating ALS Drug Development Through an Innovative Clinical Trial Design
Dr. Melanie Quintana will be presenting at the MDA Clinical & Scientific Conference on March 21 at 4:30 PM CT.
ENRICH: A Novel Approach to Clinical Trials in ICH
Dr. Ben Saville of Berry Consultants will explore essential elements of the ENRICH randomized adaptive clinical trial.
NIH Announces ALS Innovative Research Initiative
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2020 JSM Virtual Conference
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.
Los Angeles County Modeling Updates
Since March 2020, Berry Consultants LLC has been collaborating with the Los Angeles County Department of Health Services to develop COVID-19 hospital demand modeling projections, utilizing an SEIR epidemiologic model to predict hospital needs and assess the impact of physical distancing measures, with their findings prominently featured in various media outlets.
LA County COVID-19 Modeling Presentation
The Los Angeles County Department of Health Services has released a COVID-19 hospital demand modeling presentation, with assistance from Berry Consultants, along with a complete press release available online.
REMAP-CAP Study: Rationale and Design
Berry Consultants and the international REMAP-CAP team detail the Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia (REMAP-CAP) study in a manuscript published in the Annals of the American Thoracic Society.
REMAP-CAP Trial's latest information
Visit REMAPCAP.org for the latest updates and responses from the REMAP-CAP Trial regarding the COVID-19 pandemic.
2019 JSM in Denver, Colorado
Berry Consultants will sponsor and host an exhibit booth at the American Statistical Association's Joint Statistical Meetings in Denver from July 27 to August 1, 2019, where they will also present in various sessions.
New Materials Released for the NHLBI ICTR Project
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Upcoming NHLBI ICTR Webinar, September 20, 2018
In a public webinar on September 20, 2018, Berry Consultants' Kert Viele will explore the key components and trade-offs of gold standard randomized clinical trials versus innovative trial designs, discussing techniques such as flexible sample sizes and novel endpoints.
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
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2018 JSM in Vancouver
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The Release of FACTS 6.1 Software
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Berry Consultants Welcomes New Clinical Trial Strategy Team
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ARLG ADAPT Platform Trial Public Meeting
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CTTI's New Recommendations for Data Monitoring Committees
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2016 JSM in Chicago
Berry Consultants will prominently sponsor and participate in the Joint Statistical Meetings (JSM) from July 30 to August 4 in Chicago, featuring an exhibit booth (#529) and various sessions, inviting attendees to meet the team.
2015 JSM in Seattle
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Energy & Commerce Committee releases document for better and faster cures
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Dr. Donald Berry named amongst Thomson Reuters Highly Cited Researchers
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Berry Consultants a lead partner for the EPAD Initiative
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2014 ASA Biopharmaceutical Section FDA-Industry Workshop
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2014 JSM in Boston
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Congratulations to Dr. Jason Connor - Appointed to Clinical Trial Advisory Panel
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Upcoming June 2014 Conference Presentations by Kristine Broglio
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Berry Consultants Acquires FACTS
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Berry Consultants in the News
Our News & Events section now features two new articles on adaptive design for trials, including "Adaptive Clinical Design Addresses the Uncertainties" and "How Math Can Improve Drug Trials and Save Lives," with direct links available.
Upcoming 2014 Conferences in London
Berry Consultants will present at two London conferences in 2014: "Adaptive Designs in Clinical Trials" on March 24-25 featuring Dr. Roger Lewis, and "Smart Trials 2014" on April 9-10 with Anna McGlothlin, focusing on innovative approaches in clinical development.
JSM 2013, August 3-8
Berry Consultants will sponsor and host an exhibit booth at the Joint Statistical Meetings (JSM) in Montreal from August 3-8, 2013, where team members will participate in various sessions, with more details available on their website.