Developing precise and comprehensive digital measures for Myasthenia Gravis (MG) that capture meaningful aspects of the disease and address unmet needs in patient care and drug development.

​

MG is a chronic autoimmune neuromuscular disorder characterized by fluctuating muscle weakness and fatigue, significantly impacting patients' quality of life. While existing clinical outcome assessments (COAs), such as the MG-ADL, provide valuable information, there is a need for more sensitive and comprehensive measures that can detect subtle changes, predict disease progression, and inform treatment decisions. Digital health technologies, including wearable sensors, smartphone applications, and computer vision, offer the potential to capture a wider range of MG manifestations, including motor function, respiratory function, speech and swallowing ability, and vision impairment.

​

Overall Goal:

Collaboratively develop and validate a suite of digital measures for MG that complement existing COAs, address unmet patient needs, and provide clinically meaningful endpoints for clinical trials and real-world monitoring.

​

Specific Objectives:

1. Engage with Patients and Clinicians: Conduct interviews and surveys to understand the most meaningful aspects of MG to measure from both patient and clinician perspectives.

​

2. Develop Measurement Definitions: Create a collection of Measurement Definitions within the DEEP platform, each focusing on a specific concept of interest (COI) relevant to MG, such as:

a. Motor function (e.g., gait, upper extremity function, head and neck control)

b. Respiratory function (e.g., breathing patterns, respiratory muscle strength)

c. Speech and swallowing ability (e.g., articulation, voice quality, swallowing efficiency)

d. Vision and eyelid movement (e.g., visual acuity, diplopia, ptosis)

e. Quality of life (e.g., physical, emotional, and social well-being)

​

3. Design Target Solution Profiles (TSPs): Define the technical requirements and desired features of digital solutions for capturing each COI, considering various modalities such as wearable sensors, smartphone apps, and computer vision.

​

4. Develop Validation Plans: Outline strategies for validating the digital measures against existing gold standard assessments and demonstrating their sensitivity to detect meaningful changes and predict patient outcomes.

​

Potential Benefits:

· Enhanced Sensitivity: Capture subtle changes in MG manifestations that may be missed by traditional assessments.

· Patient-Centricity: Develop measures that reflect aspects of MG that are most meaningful to patients, leading to improved patient engagement and satisfaction.

· Improved Treatment Decisions: Inform treatment response, selection, and dosing optimization through continuous, real-world monitoring.

· Predictive Capabilities: Forecast disease progression and healthcare utilization, enabling proactive interventions.

· Accelerated Drug Development: Provide clinically meaningful endpoints for clinical trials, potentially leading to faster and more efficient drug development.

 

Call for Collaboration:

This initiative invites active participation from:

· Pharmaceutical companies with MG therapies in their pipeline or portfolio.

· Technology companies developing wearable sensors, smartphone applications, or computer vision technologies for healthcare.

· Device manufacturers creating innovative tools for assessing motor function, respiratory function, speech, swallowing, or vision.

· Academic Institutions: Researchers and institutions conducting clinical studies on digital measures in MG.

· Patient Advocacy Groups representing individuals with MG.

· Service providers with expertise in clinical trial design, data management, regulatory strategy, or patient engagement.

​

Ways of contributing to a DEEP collaboration mission:

There are many ways that you can contribute to a DEEP collaboration mission. Contributions can be in the form of funding, time & expertise, or prior work you have completed and would like to contribute to the cause in exchange for others contributions. DEEP's built-in legal framework and mission contracting services aim to simplify the process of collaboration for all partners who would like to engage.

​

If you have any questions, or if your organisation would like to contribute, please reach out to us here: