Clinical Trial Analysis

Revolutionizing Clinical Trials Through Virtual Controls

What are Virtual Controls? 

Virtual Controls are predicted outcomes for real trial participants as if they had received placebo. Origent’s Virtual Controls provide an innovative approach to enhance clinical trials that lack a traditional control arm. By leveraging advanced machine learning (ML) methods and rich data from historical patients, our predictive models forecast disease progression for new patients, creating a “virtual” control group. Originally developed for ALS, our models predict key outcomes such as ALSFRS-R score, vital capacity, and survival.

The Problem 

Trials without a control arm are unable to generate reliable efficacy data. Determining potential treatment effect often relies on subjective assessments, such as physician intuition. This gap in efficacy insights can hinder decision-making about future trials, delaying progress and increasing uncertainty about a treatment’s potential.

The Solution 

Origent’s Virtual Controls address this challenge by creating a virtual control group of patient outcomes to compare against observed outcomes, providing objective efficacy insights:

  1. AI-Driven Modeling: Predictive models tailored to specific diseases and trial populations simulate untreated patient outcomes.
  2. Objective Comparisons: Virtual patient outcomes serve as a comparison for evaluating therapeutic impact without subjective opinion.
  3. Validated Methodology: Rigorous validation ensures the accuracy and dependability of the predictive models.

The Benefits of Virtual Controls

  • Patient-Centric Clinical Development: Deeper use of patient contributions, minimized placebo burden, and increased trial efficiency bring therapies to patients more quickly and ethically.
  • Efficacy Insights for Safety Trials: Investigators and sponsors gain crucial efficacy insights from trials designed primarily for safety or other non-efficacy objectives.
  • Informed Decision-Making: New insights can help guide next steps, including go/no-go decisions for future trials, dosing strategies, dose timing, and outcomes, optimizing resources for subsequent trials.
  • Small Trial Value: Even limited patient data can yield actionable results, enhancing the value and ROI of small, early-phase trials.

Applicability of Virtual Controls

Virtual Controls are particularly beneficial for trials that lack a traditional control arm, such as:

  • Phase 1 and Phase 2 Trials: Focused on safety testing, where efficacy insights can be secondary but highly valuable.
  • Expanded Access Programs (EAPs): Designed to provide all patients access to experimental therapies.
  • Open Label Extension Studies: When all participants, including those in control groups, receive the experimental treatment.
  • Ethically Constrained Trials: Situations where withholding treatment is not feasible or ethical.

While Virtual Controls cannot replace control arms in Phase 3 trials intended for regulatory approval, they provide crucial insights for scientists and business executives in earlier trials to shape the future of their clinical development programs.

Why Origent? Origent brings unmatched expertise and experience to the field of Virtual Controls. Over the past decade, we have enriched insights from numerous studies, including two currently ongoing Expanded Access Programs in ALS. Our extensive library of ALS models enables us to build Virtual Controls for various outcomes. This deep knowledge positions us as a trusted partner for scientists and executives seeking to maximize the value of their clinical trials.

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