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New-Onset Cancer & Duration of Follow-up

    Basic Details
    Last Updated
    Friday, March 22, 2024
    Original Posting Date
    Health Outcome(s)
    duration of follow-up
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Postmarketing surveillance of medical products entails an assessment of both the safety of treatments among cancer patients and the risk of malignancies associated with non-cancer treatments. To better inform feasibility for future studies to address these questions, FDA initiated this study to describe the duration of follow-up among patients with new-onset cancer diagnoses in Sentinel. Sample sizes and patterns of enrollment surrounding new-onset diagnoses of nineteen cancers were analyzed. Prior to a cancer diagnosis, the median enrollment ranged from 2.3-3.6 years (among those with a required one-year minimum enrollment), depending on cancer type. Following a cancer diagnosis, the median enrollment ranged from 0.5-2.3 years. Enrollment time surrounding cancer diagnosis may provide sufficient duration of follow-up for studies in which 1) cancer is the outcome, for drug-related adverse events of relatively short latency, or 2) cancer diagnosis is a component of the cohort eligibility.