Medable Launches Digital Long-Term Follow-Up Model for Cell and Gene Therapy Trials

Medable, a U.S.-based provider of software infrastructure for decentralized clinical trials, has introduced a digital-first Long-Term Follow-Up (LTFU) model intended for use in cell and gene therapy (CGT) trials. The model is designed to support the FDA-required 15-year follow-up period applicable to certain CGTs, including genome-editing treatments such as those involving CRISPR-Cas9. These extended timelines are required to monitor delayed adverse events, assess treatment durability, and collect long-term safety data.

Maintaining participant involvement over this duration is a known challenge. A 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting found that 20% of CAR T-cell therapy recipients do not complete the full follow-up period. Of those who stop participating, 80% do so at or after five years post-treatment. Common reasons include distance from follow-up sites, lack of awareness of local options, and the time demands associated with ongoing travel.

Medable’s LTFU system offers remote and hybrid participation formats intended to reduce these barriers. The platform includes mechanisms for continuing data collection after the interventional trial phase, mobile-based reporting tools for patient self-reporting, integration with local healthcare providers for adherence monitoring, and automated communication tools to maintain contact over extended periods.

Medable states that the platform is intended to improve retention, reduce costs associated with on-site follow-up, and facilitate continuity of data across the entire observation period. The company will present the model at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago, scheduled from May 30 to June 3 (Booth #10105).

Topics: Clinical Trials