Medable has launched a digital-first long-term follow-up (LTFU) model intended for cell and gene therapy (CGT) trials, aiming to minimise the load on sites and subjects.
The platform improves scientific integrity, enabling data collection throughout the 15-year monitoring period required by the US Food and Drug Administration (FDA) for some CGTs. These include therapies employing genome-editing methods such as clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9.
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The extended monitoring is crucial for detecting delayed adverse events and assessing the long-term efficacy and impact of therapies on subjects.
According to the company, the traditional LTFU model has been challenging due to logistical and financial burdens, leading to low patient participation and high dropout rates.
Medable’s LTFU model provides remote and hybrid patient communications, allowing for in-person, virtual, or blended follow-up methods.
It also features workflow integration and data continuity, facilitating a smooth transition from interventional trials to long-term observational follow-up periods.
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By GlobalDataThe model focuses on patient-first data capture and adherence monitoring using mobile technology, questionnaires reported by subjects, and local healthcare providers to maintain consistent participation and track main endpoints.
In addition, Medable noted that its model offers tailored content, support tools, and reminders to build trust and sustain long-term engagement.
This approach not only improves retention and increases diversity among trial participants but also minimises the long-term cost burden for sites and sponsors.
Medable chief medical officer Dr Pamela Tenaerts said: “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.
“With our new LTFU model, we’re reimagining how post-treatment data is captured, putting patients at the centre while ensuring scientific and regulatory rigour.”
Last October, Medable announced a strategic collaboration with Google Cloud to bring the company’s digital, decentralised trial platform to the Google Cloud Marketplace.
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