SAN FRANCISCO--(BUSINESS WIRE)--Unlearn®, a company at the forefront of AI in the clinical trial space, today announced the launch of TrialPioneer. This web-based application is free for teams in pharmaceutical and biotech companies to collaborate and understand how trial design choices affect the sample size requirements, statistical power, and time to enrollment—initially in seven major disease areas (Alzheimer’s Disease, ALS, Crohn’s Disease, Frontotemporal Dementia, Huntington’s Disease, Parkinson's Disease, and Ischemic Stroke). It also reveals the major advantages that novel AI-powered trial designs offer over traditional approaches.
TrialPioneer is designed to make clinical trial planning more efficient for professionals, including medical directors, clinicians, and statisticians. Users can evaluate clinical trials by utilizing Unlearn's analysis of its extensive datasets from actual patient populations in completed trials. The tool addresses the impact of design decisions (primary endpoint, treatment duration, patient subpopulation, etc.) on the required sample size and/or power. It also illustrates how innovative trial designs, such as Unlearn’s TwinRCTsTM, can improve these metrics. TwinRCTs use digital twins of study participants to run highly powered studies with fewer control patients, enabling faster studies that also give more patients the opportunity to receive the experimental treatment.
Charles Fisher, founder and CEO of Unlearn, emphasized the importance of straightforward analyses for people designing clinical trials. “Everyone involved in clinical research knows that trials are frustratingly slow from the get-go. With TrialPioneer, we’re offering a free, powerful, and easy-to-use tool that enables anyone from any background to explore trial planning in a simple way, even with innovative trial designs that leverage tools like AI. We hope people will use it to make faster, more informed decisions to accelerate their research programs.”
TrialPioneer will help to bring awareness to innovative trial designs that leverage AI in regulatory-suitable ways. Unlearn has been paving the regulatory pathway for AI in clinical trials since its founding and now has a qualification for the technology underlying TwinRCTs from the European Medicines Agency for use as the primary analysis in phase 2 and 3 clinical trials with continuous outcomes, as well as agreement from the U.S. Food and Drug Administration that the methodology does not deviate from current guidance.
With the cost of bringing new medications to market reaching over $1 billion and taking as long as 14 years, efficient trial design is crucial. This process requires clinical teams to evaluate multiple factors like trial population, effect size, variance, randomization ratio, and stratification. They must perform data analyses and calculations to assess their potential impact on the trial’s sample size, power, and probability of success. TrialPioneer facilitates these analyses by allowing teams to quickly explore different trial designs, supporting more effective decision-making and potentially reducing the time and cost associated with drug development.
About Unlearn
Unlearn is a San Francisco-based technology company advancing AI to eliminate trial and error in medicine. Unlearn's technology powers the clinical trials of leading global pharmaceutical companies, helping them to reach full enrollment faster and bring new treatments to patients sooner. Their methods using participants’ digital twins are qualified by the European Medicines Agency and align with current FDA guidance. For more information, please visit https://www.unlearn.ai or follow @UnlearnAI on X and @unlearn-ai on LinkedIn.
