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Abstract:
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Compliance in clinical trials is considered an intercurrent event that affects the measurement of study outcomes. Failure to account for non-compliance adequately in the final analysis can lead to biased results. Its formal definition, however, lacks uniformity across trials. In pragmatic settings, inadequate compliance is further complicated by the absence of traditional mechanisms of patient-level monitoring. Except for the initial drug dispensed, there is very little evidence of patient-level compliance in such settings. In this session, we discuss general methods to address non-compliance in clinical trials and explore suitable definitions of compliance when trials are conducted in real-world with or without direct-to-patient engagement tools.
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