Advancing Patient-Centered Digital Measures for Myasthenia Gravis

Advancing Patient-Centered Digital Measures for Myasthenia Gravis

Gain a competitive edge by adopting cutting-edge voice biomarker technology
Improve trial efficiency with real-time, remote symptom tracking
Generate robust real-world evidence to support regulatory submissions
Position your company as a leader in digital health innovation
Myasthenia Gravis (MG) is an autoimmune disease associated with a wide variety of symptoms including muscle weakness, fatigue, shortness of breath, and slurred speech. MG symptoms impact family life, work life, the ability to perform activities of daily living and participating in social activities. While treatments can stabilize MG, symptom fluctuations make it difficult to track MG's progress and development both in clinical trials and real-world settings. Digital solutions can provide an objective and reliable way to evaluate and assess MG patients and new treatments for MG, helping improve patient outcomes.
Overall Goals:
Define the most relevant and meaningful concepts for capturing the impact of MG on patients, and to identify the right digital solutions to measure them effectively.
Specific Objectives:
Discover what matters: Identify which symptoms, experiences, and functional impacts are most important to patients with MG.
Map what to measure: Determine which aspects of the MG experience can be meaningfully and reliably measured, both in clinical trials and real-world settings.
Define digital measures: Create a structured measurement definition capturing the most relevant and patient-centered concepts for MG, organized for inclusion in the DEEP catalog.
Map technologies: Assess and map available digital technologies to the defined MG measures, identifying fit-for-purpose solutions across different contexts of use.
Lay the foundation:
Construct measure definitions and solution profiles to support future regulatory alignment and the progression from definition mission to regulatory acceptance mission.
Mission Benefits:
Gain a strategic head start in building MG real-world evidence programs
Improve trial efficiency with real-time, remote symptom tracking
Generate robust real-world evidence to support regulatory submissions
Position your company as a leader in digital health innovation
Establish reusable digital measure components for Myasthenia Gravis that are patient-centric and fit-for-purpose across clinical and real-world contexts.
Access a global MG cohort and real-world data to inform measure selection and support future validation efforts.
Accelerate regulatory and clinical pathways with sensitive digital measures that enable faster program decisions and de-risk future trials.
Strengthen competitive positioning through early adoption of MG digital measures and differentiated evidence for market access and reimbursement.
Enhance treatment optimization by developing tools that support better decision making and improve patient outcomes in real-world settings.
Prepare for pivotal studies and real-world deployments with clear understanding of which measures and technologies are fit-for-purpose and ready for immediate internal use.
Opportunities for scientific leadership and collaboration, including publication opportunities, engagement with MG experts and patient advocacy groups.
Call for Collaboration:
This initiative invites active participation from:
Pharmaceutical companies developing therapies for Myasthenia Gravis (MG), or those with MG treatments already in their pipeline or portfolio.
Partners will gain the opportunity to help shape validated digital measures for MG, access early insights from patient and clinician data, and position their programs for leadership in future clinical trials and real-world applications.
If you have questions, or if your organization is interested, please reach out to us here by 31st July 2025.