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Episode 43, “The Rumor of One Trial for Substantial Evidence”
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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.
Rumors persist that the FDA could replace the familiar two-trial requirement for substantial evidence with a single trial—with more statistically demanding thresholds.
In episode 43 of "In the Interim…," Dr. Scott Berry and Dr. Kert Viele analyze this possible shift, both believing the one trial hurdle could provide better analyzes, and not lowering the bar, but it completely depends on the hurdle for that single trial. Both believe one trial at 0.000625 is better than two at 0.025 and the sample size needs are smaller.
They critique the duplicative, arbitrary nature of current standards, emphasizing that robust approvals rest on accumulating enough rigorous evidence.
Tune into the full episode today: https://www.berryconsultants.com/resource/43-the-rumor-of-one-trial-for-substantial-evidence
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Episode 43, “The Rumor of One Trial for Substantial Evidence”
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.
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Today’s episode, “External Data in Clinical Trials"
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February 2025 FACTS Webinar
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Mike Krams, M.D. joins the Berry Consultants Team
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FACTS 7.1 Release
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FACTS Webinar Series in Oct. and Nov.
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ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
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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
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ASA JSM 2024
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July 2024 FACTS Webinar
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PSI: Statisticians in the Pharmaceutical Industry Conference
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Summer Biometric Seminar of the Viennese Section of the International Biometric Society
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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
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April 2024 FACTS Webinar
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March 2024 FACTS Webinar
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International Society for Biopharmaceutical Statistics Symposium March 6th-9th
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2024 ENAR Spring Meeting March 10th-13th
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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
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ASA Biopharmaceutical Industry Statistics Workshop
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Futility in Clinical Trials
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PSI 2023 Conference June 11-June 14
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44th Annual SCT Meeting
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FDA/AdvaMed Medical Device Statistical Issues Conference
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Advanced Statistical Methods to Borrow External Information
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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
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Accelerating ALS Drug Development Through an Innovative Clinical Trial Design
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ENRICH: A Novel Approach to Clinical Trials in ICH
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2020 JSM Virtual Conference
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Los Angeles County Modeling Updates
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LA County COVID-19 Modeling Presentation
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REMAP-CAP Trial's latest information
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2019 JSM in Denver, Colorado
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Upcoming NHLBI ICTR Webinar, September 20, 2018
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2018 JSM in Vancouver
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