Phase IV Postmarketing surveillance

A new treatment may become established with relatively little knowledge of its long-term effects. 'Phase IV' evaluation usually refers to the study of adverse events and late morbidity and mortality in cohorts of patients who have undergone such treatment. These studies perhaps assume most importance when treating non-fatal conditions, where adverse effects may be relatively rare and/or may not become obvious until some time after the efficacy of the treatment has been determined. Many phase III cancer trials are evaluating the impact of treatment on survival and necessarily follow patients for most of their life; in this situation, evaluation of late effects is actually an integral part of the phase III trial.

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  • Taneli Rintanen
    What is "surveillance clinical trials"?
    8 years ago

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