We often quote GEP Box on "all models are wrong; some are useful", but we do a terrible job bringing one of this great statistician's body of work to drug development: Design of Experiments. Sure, we do a little D-optimal design for sampling times, maybe a crossover study... but it's pretty primitive. Andrew Hooker, France Mentre, Stephen Duffull and others have suggested more ways to bring more DoE into clinical drug development, so I'm in good company with this effort.
Basically, Definitive Screening Designs allow us to study N factors (dose, schedule, possibly important patient factors, etc.) at three levels each with 2*N+1 cohorts. These designs are incredibly dense (technically, "supersaturated"), can be analyzed using simple ANOVA approaches for significance testing, and support model-based analysis to boot.
Our manufacturing colleagues are doing this already under Quality-by-Design auspices. We're late to the party, and our patients deserve better, faster, and more informative studies.
𝗕𝗲𝗵𝗶𝗻𝗱 𝘁𝗵𝗲 𝗦𝗰𝗶𝗲𝗻𝗰𝗲: 𝗔𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗶𝗻𝗴 𝗖𝗔𝗥 𝗧 𝗖𝗲𝗹𝗹 𝗧𝗵𝗲𝗿𝗮𝗽𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝘄𝗶𝘁𝗵 𝗔𝘂𝗴𝗺𝗲𝗻𝘁𝗲𝗱 𝗦𝗰𝗿𝗲𝗲𝗻𝗶𝗻𝗴 𝗗𝗲𝘀𝗶𝗴𝗻
Traditional phase 1 trials for CAR T cell therapy can be slow and resource-heavy. Our 𝗔𝘂𝗴𝗺𝗲𝗻𝘁𝗲𝗱 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝘃𝗲 𝗦𝗰𝗿𝗲𝗲𝗻𝗶𝗻𝗴 𝗗𝗲𝘀𝗶𝗴𝗻 (𝗗𝗦𝗗) streamlines this process, using advanced simulations to optimize dose combinations with fewer cohorts. The result? Up to a 2.37x higher chance of achieving a favorable benefit-risk profile, accelerating development and improving patient outcomes.
💡 𝗗𝗶𝘀𝗰𝗼𝘃𝗲𝗿 𝗠𝗼𝗿𝗲: Check out our ACoP poster: https://ow.ly/VMYt50Uk5PM
🧠 𝗖𝗼𝗻𝘁𝗿𝗶𝗯𝘂𝘁𝗼𝗿𝘀: Michael Dodds | Mirjam Trame | Leandro Pippa
🗓️ 𝗟𝗲𝘁’𝘀 𝗖𝗼𝗻𝗻𝗲𝗰𝘁: Book a complimentary 15-minute consultation: https://ow.ly/jL8850Uk5PN
#ClinicalTrials #CancerResearch #PrecisionMedicine #InnovativeDesign #ACoP15
Reaching 10,000 patients treated with cell therapies is a monumental achievement! This milestone reflects not just innovation but also the hope and dedication of so many individuals working together to transform lives. Thank you for continuing to push boundaries in patient care. 💙