Follow-up is the period after completion of active treatment during which participants continue to be monitored in order to capture long-term effects, delayed adverse reactions, or parameters such as overall survival. In oncology or gene therapy, this period can span many years and is decisive for the final benefit-risk assessment.
Complete follow-up is essential for statistical power. Patients who are lost to follow-up weaken the validity of the analysis (e.g. Kaplan-Meier). CROs employ specific patient retention strategies here to ensure high data quality over long periods.
From a regulatory perspective, follow-up is often part of post-authorisation obligations (PASS). Technologically, ePRO systems and telemedicine support data collection during this phase, as they minimise the burden on the patient by reducing on-site visits. These long-term data are also of high value for negotiations with payers (health economics).
Mediconomics – für individuelle CRO-Lösungen.
