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Using cancer registries to supplement clinical trial data and inform regulatory decision

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Cancer is a major cause of morbidity and mortality worldwide, particularly in high‐income countries. The burden of disease is immense for patients, their caregivers, and for health care systems. Although… Click to show full abstract

Cancer is a major cause of morbidity and mortality worldwide, particularly in high‐income countries. The burden of disease is immense for patients, their caregivers, and for health care systems. Although treatment options have been expanding and progressively with greater chances of cure or of longer survival, some cancers still have very limited treatment options. The rising costs of treatment are well portrayed in the literature and often aside with lower degree of evidence leading to market entry. This calls for additional efforts in gathering real‐life evidence to supplement clinical trial data. However, for these data to be reliable and useful, some pre‐assumptions need warranty, namely, the quality of data. The three main aspects that should be evaluated to judge data quality are comparability, completeness, and validity. In addition, ideally timeliness of registry procedures should also be taken into account.

Keywords: using cancer; clinical trial; trial data; supplement clinical

Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2020

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