Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access

Business Wire

5 days ago

PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships.
By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution.
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CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers.
'Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors,' said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. 'With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor.'
Medable's digital-first LTFU offering includes:
Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances.
Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up.
Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time.
Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection.
By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites.
Medable Booth # 10105.
About Medable
Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024.