December 11, 2024
Enhancing Phase II and III Trials by Increasing Statistical Power and Reducing Sample Sizes
Unlearn, a leader in artificial intelligence for clinical trials, has entered into a partnership with APST Research to utilize its extensive patient dataset for the development of advanced digital twin models. These AI-driven models aim to support clinical trials for amyotrophic lateral sclerosis (ALS) by improving trial efficiency and optimizing study design.
Building Digital Twins with Real-World Data
Under this agreement, Unlearn will leverage data from 8,000 participants enrolled in APST Research’s longitudinal ALS study. These digital twin generators—AI models trained on individual patient data—will be refined using this dataset to improve predictive accuracy and broaden their functionality. In Phase II and III trials, these models will help boost statistical power while reducing the number of participants needed.
Unlocking Deeper Insights for Drug Development
The dataset includes patient-reported outcomes, biomarker assessments, and critical ALS clinical trial metrics, such as ALS Functional Rating Scale-Revised (ALSFRS-R), Slow Vital Capacity (SVC), Forced Vital Capacity (FVC), and neurofilament light chain (NfL) levels. A key strength of the APST dataset is its rich NfL measurements, which are combined with disease history, genetic profiles, and demographic data. This enables Unlearn’s digital twin models to better reflect current ALS trial designs, particularly those incorporating NfL as a biomarker.
AI’s Edge in Clinical Research
AI’s ability to model complex, non-linear interactions offers a significant advantage over traditional statistical methods. By generating comprehensive digital twins, Unlearn’s platform can simultaneously predict multiple variables, allowing research teams to conduct more efficient trials and accelerate drug development. These AI-driven models also help identify patient subgroups with stronger treatment responses, paving the way for more personalized therapies.
Driving Innovation Through Collaboration
Beyond clinical applications, Unlearn and APST Research will co-author scientific publications on the use of digital twins in clinical research. Additionally, Unlearn will provide APST with AI-generated digital twins of study participants to further advance ALS research.
This collaboration marks a pivotal move toward integrating AI-based methodologies into ALS drug development, emphasizing the transformative role of digital twins in the future of clinical trials.
About Unlearn AI
Unlearn is transforming clinical research with AI-generated digital twins that help pharmaceutical and biotech companies streamline clinical trials and make informed decisions. Recognized by global regulatory bodies, Unlearn’s technology aligns with FDA guidelines and is EMA-qualified for Phase III trials. Unlearn AI News
About APST Research
APST is a digital research platform working with leading ALS centers across Germany and Europe to collect clinical, phenotypic, biomarker, and patient-reported data. Through its mobile “ALS App,” APST engages over 2,000 people living with ALS, gathering reliable and patient-centered insights. With a dataset encompassing more than 9,000 ALS patients, APST supports biotech firms, pharmaceutical companies, and AI innovators in the development of effective ALS treatments. Learn more about APST Research
By
