Technology company Unlearn has introduced the latest version of its TwinRCT solution, TwinRCT 3.0, to enhance decision-making in Phase II clinical trials.

TwinRCTs are randomised trials that use digital twins of study subjects, generating forecasts of individual outcomes, to optimise trial processes.

The digital twins of trial subjects are created using AI models trained on patient-level data and facilitate the conduct of trials with higher power or smaller control groups.

TwinRCT 3.0 now includes additional historical trial data to improve Phase II trial evaluations, a pivotal stage in the process of drug development.

As Phase II trials are critical for assessing a new drug's effectiveness, a highly powered trial at this stage increases the chances of rapidly detecting the precise benefits of the treatment, which is essential for progressing to Phase III.

Traditional methods to increase trial power involve enrolling more subjects, which is costly and time-consuming. TwinRCTs can tackle this issue by enhancing trial power, without requiring additional participants to be enrolled.

According to findings from a recent case study re-evaluating an Alzheimer’s disease study, a traditional trial would need 23% more subjects to match the power of Unlearn’s updated TwinRCT.

This equates to an additional five months for participant enrolment. Such efficiency gains from the updated TwinRCT signify an advancement in clinical trial design.

TwinRCT 3.0 has been integrated into TrialPioneer, Unlearn’s complimentary web-based platform.

This application, introduced recently, is designed to assist pharmaceutical and biotech enterprises in evaluating how trial design influences sample size, statistical power, and enrolment timelines.

Alzheimer's disease, ALS, Crohn's disease, frontotemporal dementia, Huntington's disease, Parkinson's disease, and ischemic stroke are the seven main disease categories for which TrialPioneer is currently accessible.

Last month, Unlearn secured $50m in Series C funding. The investment round was led by Altimeter Capital and will be directed towards optimising clinical research through digital twin technology.