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).

旧金山——（商业新闻短讯）——Unlearn®，一家在临床试验领域处于人工智能前沿的公司，今天宣布推出TrialPioneer。这个基于网络的应用程序是免费的，制药和生物技术公司的团队可以合作并了解试验设计选择如何影响样本量要求，统计能力以及最初在七个主要疾病领域（阿尔茨海默氏病，ALS，克罗恩病，额颞叶痴呆，亨廷顿氏病，帕金森氏病和缺血性中风）注册的时间。

It also reveals the major advantages that novel AI-powered trial designs offer over traditional approaches..

它还揭示了新型人工智能驱动的试验设计相对于传统方法提供的主要优势。。

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.

TrialPioneer旨在为专业人员（包括医学总监、临床医生和统计学家）提供更高效的临床试验计划。用户可以通过利用Unlearn对已完成试验中实际患者人群的广泛数据集进行分析来评估临床试验。该工具解决了设计决策（主要终点，治疗持续时间，患者亚群等）对所需样本量和/或功效的影响。

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..

它还说明了创新的试验设计，如Unlearn的TwinRCTsTM，如何改进这些指标。TwinRCT使用研究参与者的数字双胞胎，以较少的对照患者进行高效研究，从而实现更快的研究，也为更多患者提供接受实验治疗的机会。。

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.

Unlearn的创始人兼首席执行官查尔斯·费舍尔（CharlesFisher）强调了对设计临床试验的人进行直接分析的重要性。“参与临床研究的每个人都知道，试验从一开始就令人沮丧地缓慢。通过TrialPioner，我们提供了一个免费、强大且易于使用的工具，使任何背景的人都能够以简单的方式探索试验计划，即使是利用AI等工具的创新试验设计。

We hope people will use it to make faster, more informed decisions to accelerate their research programs.”.

我们希望人们能利用它做出更快、更明智的决定，以加速他们的研究计划。”。

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.

TrialPioner将有助于提高人们对创新试验设计的认识，这些试验设计以适合监管的方式利用人工智能。Unlearn自成立以来一直在为AI在临床试验中的监管途径铺平道路，现在拥有欧洲药品管理局TwinRCT基础技术的资格，可作为2期和3期临床试验的主要分析，并取得持续的结果，以及美国的同意。

Food and Drug Administration that the methodology does not deviate from current guidance..

美国食品和药物管理局表示，该方法不会偏离当前的指导。。

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.

由于将新药推向市场的成本超过10亿美元，需要长达14年的时间，因此有效的试验设计至关重要。这个过程需要临床团队评估多种因素，如试验人群，效应大小，方差，随机化比率和分层。他们必须进行数据分析和计算，以评估其对试验样本量，功效和成功概率的潜在影响。

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..

TrialPioner通过允许团队快速探索不同的试验设计，支持更有效的决策，并可能减少与药物开发相关的时间和成本，从而促进了这些分析。。

About Unlearn

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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.

Unlearn是一家总部位于旧金山的技术公司，致力于推进人工智能，以消除医学中的反复试验。Unlearn的技术为领先的全球制药公司的临床试验提供了动力，帮助它们更快地达到全部注册，并更快地为患者带来新的治疗方法。他们使用参与者数字双胞胎的方法得到了欧洲药品管理局的认证，并符合当前FDA的指导。

For more information, please visit https://www.unlearn.ai or follow @UnlearnAI on X and @unlearn-ai on LinkedIn..

有关更多信息，请访问https://www.unlearn.ai或者在X上关注@UnlearnAI，在LinkedIn上关注@UnlearnAI。。