Abstract

Adverse event monitoring in oncology clinical trials

Author(s): Jeffery S Russell , A Dimitrios Colevas

Treating oncology patients with potentially toxic drugs is balanced with the premise of ‘do no harm.’ Most drugs are approved by the US FDA based on analysis of the clinical benefit-to-risk ratio. As such, adverse event (AE) reporting is a crucial aspect of oncology clinical trials. Attribution of symptoms can be difficult because there can be a lack of clarity concerning what is disease-related, treatment-related, a co-morbid illness or a combination of all three. Additionally, as cancer progresses, both the symptoms and treatments evolve, resulting in a complex, time-dependent relationship. If toxicities that are not actually the result of an investigational agent are inappropriately attributed to that agent during Phase I development, further study of a potentially useful drug may be delayed or abandoned. In contrast, if there is an underreporting of drug-attributable AEs in Phase I development, there will be unnecessary patient risk and expense with subsequent clinical development when the relationship between the AEs and the drug emerges. Given the large amount of data generated from clinical trials, the reliability of collecting and recording these results in modern multimodality oncology trials is increasingly complicated. Accurate toxicity reporting is integral for a true assessment of drug efficacy, economic evaluation and regulatory decision making