The American Society of Clinical Oncology (ASCO) Decision Aid appears to help physician-investigators and research staff accurately determine whether a serious adverse event (SAE) was related to the investigational drug, according to a study recently published in the Journal of Oncology Practice

The study included a convenience sample of 35 physician-investigators and research staff from US-based community and academic research sites. Participants were asked to complete 2 surveys, which had case studies and questions about reporting and attribution of SAEs. The first survey measured accuracy of reporting and attribution of SAEs at baseline (before the Decision Aid), and the second survey was done with the Decision Aid.

The study researchers found that in general, the use of the Decision Aid did not actually improve participants’ ability to determine whether an adverse event was serious and therefore, should be submitted in a report to the sponsor. However, the use of the Decision Aid did improve the participants’ ability to accurately determine whether an SAE was related to administration of the investigational drug. 

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Participants were also asked for feedback about the Decision Aid, and overall, 93.1% found it useful — specifically, 51.7% found it and very helpful and 41.4% found it somewhat helpful, and nearly 83% said they would use it in practice. Also, 82.8% claimed the Decision Aid raised confidence about their responses.

The sample was small and heterogenous, and as a result the findings are not generalizable to all physician-investigators and research staff involved in SAE reporting, according to the study authors. 

“The Decision Aid shows promise as a method to improve the quality of SAE attribution, which may improve the detection of valid safety signals and reduce the administrative burden of uninformative investigational new drug safety reports,” the study authors wrote. 

Disclosure: The authors of the original study disclosed financial ties to the pharmaceutical industry. For a full list of disclosures, please refer to the original study.

Reference

  1. Mileham KF, Schenkel C, Chuk MK, et al. Assessing an ASCO Decision Aid for improving the accuracy and attribution of serious adverse event reporting from investigators to sponsors [published online October 24, 2019]. J Oncol Pract. doi: 10.1200/JOP.19.00366