Unlearn has unveiled a web-based application aimed at revolutionising the efficiency of clinical trial planning.
TrialPioneer is now available for free to pharmaceutical and biotech enterprises, offering insights into how various trial design choices can influence sample size needs, statistical power, and enrolment timelines.
In the initial stage, the tool is equipped to provide insights into seven major disease areas, namely Alzheimer’s, ALS, Crohn’s, Frontotemporal dementia, Huntington’s, Parkinson's, and ischemic stroke.
TrialPioneer is tailored to enhance the workflow of medical directors, clinicians, and statisticians.
It utilises comprehensive datasets of Unlearn from past patient populations to allow users to assess the impact of trial design decisions on essential metrics such as sample size and power.
Additionally, the application shows how TwinRCTs of Unlearn can optimise these metrics by using digital twins to conduct more efficient clinical trials.
TrialPioneer will assist in raising awareness of trial designs that use AI in compliance with regulations.
The European Medicines Agency qualified the technology that powers TwinRCTs for use as the primary analysis in Phase II and Phase III clinical trials with continuous outcomes. The US Food and Drug Administration has agreed that the methodology does not deviate from current guidelines.
The escalating costs associated with new medication development, which can exceed $1bn and take up to 14 years, underscore the importance of efficient trial design.
Clinical teams are tasked with evaluating numerous variables and conducting analyses to determine their potential effects on a trial's sample size, power, and success probability.
TrialPioneer streamlines this process, enabling teams to rapidly explore various trial designs, thus facilitating more informed decision-making and potentially reducing the time and cost of drug development.
Unlearn founder and CEO Charles Fisher said: “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 programmes.”
The latest development comes after Unlearn secured $50m in a Series C funding round led by Altimeter Capital, for optimising clinical research with digital twin technology.
