Betsy Foss-Campbell’s Post

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Regulatory Policy Strategist

Check out our white paper that highlights the challenges of obtaining needed long-term safety data after CAR T-cell therapy and potential ways to address them from patients' perspectives.

🗣️ New White Paper: Long-Term Follow-Up Studies from the Patient Lens Patient perspectives are crucial for sponsors and regulators to consider when designing each aspect of a clinical trial, including long-term follow-up (LTFU) requirements. In a recent survey conducted in collaboration with #EmilyWhiteheadFoundation, we gathered feedback from nearly 100 CAR T therapy recipients and caregivers. Findings revealed that participation in LTFU declines over time, with respondents highlighting challenges like travel barriers and insufficient understanding of certain LTFU processes and purposes. These challenges may prevent participation in LTFU studies for the required 15 years and warrant the need for more patient-friendly expectations, collaborative conversations, and creative modifications to the existing LTFU framework for CAR-T therapies. #CART #CellTherapy #PatientFirst #PatientVoice #ClinicalTrials Read the full report on our website: https://lnkd.in/ecmPmBTE

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