SAN FRANCISCO–(BUSINESS WIRE)–Unlearn®, a company at the forefront of AI in medicine, today announced the newest version of its TwinRCT™ solution, TwinRCT 3.0. TwinRCTs are randomized clinical trials that use digital twins of trial participants—comprehensive forecasts of individual clinical outcomes—to optimize clinical trials. Participants’ digital twins are generated by AI models trained on patient-level data, and they enable trials with higher power or smaller control arms.
Unlearn’s updated TwinRCT can now incorporate additional previous clinical trial data to provide an even more robust framework for Phase 2 trial evaluations, which represent a crucial stage in the drug development process. Phase 2 trials serve as a litmus test for a new drug’s effectiveness. The more highly powered a trial is at this stage, the more likely a treatment effect can be detected—determining whether or not the trial will advance to the more resource-intensive Phase 3 stage. Seeking more power in Phase 2 trials is a common approach in order to understand a new drug’s potential benefits quickly and accurately. Traditionally, increasing the number of participants could help, but it’s a slow and expensive approach.
TwinRCTs can overcome this issue by increasing power without adding additional participants. The results of a case study reanalyzing a completed Alzheimer’s Disease study demonstrate that a traditional trial would require 23% more trial participants to achieve the same power as Unlearn’s updated TwinRCT. Adding these additional participants could increase the time to enrollment by five months. This power gain boosts the efficiency and precision the updated TwinRCTs bring to the table, marking a substantial step forward in clinical trial design and analysis.
Additionally, the updated TwinRCT version has been added to TrialPioneer, Unlearn’s free web-based application, which enables pharmaceutical and biotech companies to collaborate and understand how trial design choices affect sample size requirements, statistical power, and time to enrollment. TrialPioneer is currently available for seven major disease areas (Alzheimer’s Disease, ALS, Crohn’s Disease, Frontotemporal Dementia, Huntington’s Disease, Parkinson’s Disease, and Ischemic Stroke), with more diseases added regularly. TrialPioneer also highlights the major advantages that Unlearn’s novel AI-powered trial designs offer over traditional approaches.
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