Berry Consultants, LLC

⏰ Reminder ⏰ Our FACTS Software webinar series kicks off this Thursday, Oct 17 at 11AM EDT with Scott Berry presenting a case study on the design of a seamless phase 2/3, multiple endpoint trial in diabetes.  Don’t miss it and sign up today at: https://lnkd.in/gfacZ2wn

Berry Consultants is pleased to announce a 6-week public webinar series on "Case Studies in using FACTS to design Clinical Trials". These live Zoom webinars will be from October 17th through November 21st, 2024, and each session will demonstrate simulation guided trial design using our simulation software FACTS. Join one, some, or all six sessions for free. You won’t want to miss them!  Register in advance for each Zoom webinar session at: https://lnkd.in/gfacZ2wn

In this Podcast episode by SciPod Health and Medicine (https://lnkd.in/gephpxGS), it summarizes the recent paper “Lecanemab for Patients with Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial”. In addition, it describes the benefit and success of adaptive clinical trial design within a Bayesian statistical approach not only within this Eisai Alzheimer trial, but many other trials. One example it highlights in another disease area, is the AWARD-5 trial for Eli Lilly’s type 2 diabetes drug Trulicity that has made it the most successful and profitable drug ever for Eli Lilly.

Berry Consultants is excited to be a Principal Sponsor of next week’s ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Rockville, MD on Sept 25th -27th.  Stop by our exhibit booth to meet our team and learn more about our trial design, implementation, and software solutions. For more information about the workshop and to register, please see: https://lnkd.in/gHNjqm_4 Hope to see you there!

Another great opportunity to learn more about Adaptive Clinical Trial Designs and Response Adaptive Randomization. Access the free module below!

This month’s FACTS Software webinar will be on August 23rd at 11am EDT and will focus on interactive results exploration and visualization in FACTS.  FACTS developer Elias Meyer will present on how to learn more about your designs and create bespoke figures using the R Shiny App AIRSHIP. To join this session (free and open to the public), please register in advance on our website at: https://lnkd.in/eZzF_tEb

Berry Consultants is proud to sponsor next week’s ASA #JSM2024!  Stop by our exhibit booth #101 to meet the team, learn more about our adaptive clinical trial design and implementation services, and get a demo of our latest software products.  Hope to see you there!

I'm presenting a free webinar this Friday on the idea of "continuous enrollment" in dose escalation oncology trials rather than "cohort enrollment". The idea has been around in various forms for nearly the last ten years - the Roling 6 design, Anastasia Ivanova's "Rapid Enrollment", the option to "Backfill" in BOIN. Whilst we are waiting for the current cohort to complete, if another patient becomes eligible for our trial rather than turning them away ("losing" them) can we enroll them in our trial in a useful but not risky manner? Our trial might enroll more subjects, but it might also complete more quickly which might be an attractive trade-off. In our FACTS trial simulation software, for some years we have had the option to include this in the simulation of CRM (a.k.a Baysian Logistic Regression) designs but the options and simulated behavior are quite complex, so in this talk we lift the veil and look and it all works. If your interested in attending the webinar or would like to receive a link to the recording once its complete, please register here: https://lnkd.in/eysDYJS4 Best Regards, Tom Parke, Berry Consultants

Dr Philip White and Dr Melanie Quintana of Berry Consultants, LLC presented data from our successful Phase 1 MEND study at the annual meeting of #ENCALS. The data highlighted the statistically significant survival benefit for patients treated with monepantel compared to untreated matched-controls from the PRO-ACT database: https://buff.ly/4c4eyHF #MND #ALS Click here to view the poster being presented: https://buff.ly/4esMdMJ Click here to view a video of Dr Philip White presenting the poster: https://buff.ly/3VLOQ51

Reminder don’t miss this Friday’s June 21st summer seminar of the Viennese Section of the International Biometric Society that is co-organized by the Medical University of Vienna and Berry Consultants. For more information, please see our website link at:  https://lnkd.in/gfZi2wKw