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AI-Driven Patient Engagement: How Trially and Margo Achieve Clinical Trial Optimization Goals

Trially Branded Image
Trially Branded Image
Trially Branded Image

Trially’s AI platform, featuring the Margo AI Agent, provides operational solutions that directly address the strategic challenges and digital implementation hurdles identified in recent articles by by experts like Dinesh Pillaipakkamnatt (former Director, Business Enablement Lead in Digital Innovation Merck executive) and Sagar Vaidya (Chief Medical Officer of Cerevance). By leveraging Large Language Models (LLMs) to automate site-level workflows, Trially reduces site burden, maximizes patient engagement, and ensures data integrity in the shift toward Decentralized Clinical Trials (DCTs) and Digital Health Technologies (DHTs).

1. Reconciling Precision Enrollment with Site Burden and Cost Mitigation

A critical intersection in clinical research is the need for speed and precision against the heavy manual burden placed on site staff, which directly leads to costly delays.

Alignment with Vaidya’s Objectives (Efficiency and Patient-Centricity)

Vaidya stresses that failure to recruit leads to delays costing up to $8m per day in opportunity costs. He also advises that successful protocols must be designed to reduce site burden and ensure enrollment of the right patients with unmet need.

  • Eliminating Manual Burden: Trially’s LLM-powered matching engine (Trially Match) directly solves the site burden issue by eliminating the need for Clinical Research Coordinators (CRCs) to spend 250+ hours per month per site on manual screening. Trially achieves a 90% reduction in manual EHR chart review hours. This reduction frees up CRCs to execute the high-touch, patient-centric engagement Vaidya promotes.

  • Precision Matching: Trially’s technology synthesizes 100% of EHR data (structured and unstructured) to match patients with ~95% accuracy. This precision ensures sites are recruiting the "right patients" and drastically reduces the financial impact of failed screenings, resulting in a 73% reduction in screen failure rates.

Alignment with Pillaipakkamnatt’s Digital Transition Strategy (DCTs)

Pillaipakkamnatt notes the future dependence on DCTs/DHTs, projecting that 70% of trial data will be sourced digitally. However, patient retention is a major challenge, with nearly one-third of participants dropping out.

  • Accessing Untapped Potential: Pillaipakkamnatt highlights that reaching patients where they are based represents nearly 80% of untapped potential. Trially maximizes the use of existing clinical data, enabling sites to access 10x candidates on Day 1 by matching patients against their comprehensive EHR history, thereby unlocking potential within the existing site population.

  • Driving Enrollment: Trially directly boosts enrollment (often 2-6X more patients enrolled per month in complex studies) by focusing on the "last mile" of recruitment, ensuring that the necessary digital tools successfully convert leads, thus mitigating the risk of high drop-out rates.

2. Margo: Automating the Patient Engagement Workflow and Adherence

Both experts stress that getting patients engaged is key. This works best by staying in constant touch and using helpful tools, like alerts and nudges, to make sure they stick with the program. Trially specifically targets the "Patient-Physician Handoff" and "Lead Conversion" problem where "qualified candidates often slip away".  The Margo AI Agent, operating within Trially Connect, fully automates this required engagement layer:

  • Sustained Engagement Execution: Margo serves as the automated execution engine, handling pre-screening, scheduling appointments, and sending reminders via SMS, Voice, and email. This automated communication workflow directly provides the "alerts, nudges, and community groups" Pillaipakkamnatt suggested were necessary to drive patient adherence in remote services.

  • Targeted Follow-up: Margo optimizes the conversion funnel by focusing on the "warmest leads". The AI agent specifically prescreens patients based on upcoming visits, ensuring the intervention occurs "at the point of care".

  • Building a Trial-Ready Population: Margo actively re-engages dormant patient populations, satisfying Vaidya’s call for continuous engagement to ensure site readiness.

  • Recruitment Dashboards and Transparency: Vaidya recommends using tools like recruitment dashboards. Margo supports this by generating real-time patient qualification summaries. This summary, which includes necessary documentation, facilitates an informed and efficient physician handoff, improving the quality of patient-physician interaction.

3. Addressing Digital Implementation Challenges and Data Integrity

Pillaipakkamnatt noted that implementing digital solutions often involves significant costs and challenges related to data quality and security.

  • Cost-Effectiveness and Experimentation:Trially saves money because it uses the patient data already in the hospital's electronic health record (EHR) system. This means you don't have to buy or manage expensive, specialized medical devices. Because it can be set up in just one day, it proves Pillaipakkamnatt's point that testing ideas quickly is the best way to see if they work.

  • Data Security and Privacy: Pillaipakkamnatt advised that secure cloud servers should be siloed by both trial location and trial to prevent data crossing. Trially directly addresses this necessity with superior security controls:

    • The platform is 100% compliant with stringent standards including HIPAA, SOC 2, FDA Part 11, ISO 27001 and IRB.

    • Trially ensures isolated storage, identity, and data infrastructure per client, using private servers and SQL instances, thereby fulfilling the requirement for siloed data protection.

©

All rights reserved.

All information presented is for illustrative purposes only and does not represent actual data. Trially's product is fully compliant with HIPAA, SOC 2, FDA 21 CFR Part 11 and ISO 27001 regulations, ensuring the highest level of data security, safety and privacy.

©

All rights reserved.

All information presented is for illustrative purposes only and does not represent actual data. Trially's product is fully compliant with HIPAA, SOC 2, FDA 21 CFR Part 11 and ISO 27001 regulations, ensuring the highest level of data security, safety and privacy.

©

All rights reserved.

All information presented is for illustrative purposes only and does not represent actual data. Trially's product is fully compliant with HIPAA, SOC 2, FDA 21 CFR Part 11 and ISO 27001 regulations, ensuring the highest level of data security, safety and privacy.