New TrialPioneer online tool can help companies explore trial designs
Unlearn launches free AI-based tool for use in Parkinson's, other conditions
A newly launched online tool called TrialPioneer, which makes use of artificial intelligence (AI), aims to help pharmaceutical and biotech companies explore different clinical trial designs for their work in seven major medical conditions, including Parkinson’s disease.
Unlearn, a California-based company, developed the new technology to help research teams better design their own clinical trials. The online tool, which is free, will allow companies to explore various trial designs, and factors such as the number of participants, statistical power, and time to enrollment.
The goal ultimately is to reduce the time and costs of development for novel therapies, according to the company.
“Everyone involved in clinical research knows that trials are frustratingly slow from the get-go,” Charles Fisher, PhD, Unlearn’s founder and CEO, said in a press release.
“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,” Fisher said.
Online tool, free to researchers, aims to speed treatment development
According to the Unlearn, the costs of bringing new medications to market can reach more than $1 billion and take up to 14 years. The process requires clinical teams to evaluate several trial factors, including study population, number and stratification of participants, randomization ratio, and statistical power — all needed to ensure the resulting study will accurately assess the safety and effectiveness of the treatment being tested.
An online tool, TrialPioneer eases these analyses by allowing teams to quickly test different trial designs using AI. It aims to support decision-making by researchers and to accelerate the development of new therapies that can reach patients sooner.
We hope people will use [TrialPioneer] to make faster, more informed decisions to accelerate their research programs.
The technology leverages the company’s analysis of extensive datasets from real patient populations in completed trials to address the impact of design decisions, such as primary goal, treatment duration, or patient subpopulation. It also shows how innovative trial designs, such as Unlearn’s TwinRCTs, may enable a more efficient process.
TwinRCTs use digital twins — a copy of the study’s participants that allows researchers to observe a patient in real-time while simulating and predicting a different clinical outcome — to run studies with fewer control participants, allowing more patients to receive the experimental treatment while reducing the study’s duration.
The company has been seeking regulatory approval, having reached a qualification from the European Medicines Agency in 2022 for PROCOVA statistical procedure, the technology underlying TwinRCTs. This provides a regulatory framework for its use in Phase 2 and 3 clinical trials with continuous outcomes.
In addition to Parkinson’s, the online tool is now available for Alzheimer’s disease, ALS, Crohn’s disease, frontotemporal dementia, Huntington’s disease, and ischemic stroke.
The technology also aligns with current guidance from the U.S. Food and Drug Administration.
“We hope people will use [TrialPioneer] to make faster, more informed decisions to accelerate their research programs,” Fisher said.
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