The Reporting of Adverse Events in Oncology Phase III Trials
Background
Determination of drug safety and tolerability in oncology trials often focuses on the frequency of certain key adverse events (AEs) rather than all-grade toxicities. This study aimed to assess the reporting of key AEs in oncology randomized, controlled trials (RCTs) and compare it with the expectations of the EORTC membership.
Materials and Methods
RCTs reports published between 2007 and 2011 were reviewed for the reporting of key AEs, including grade 3/4 AEs, grade 5 AEs, and AEs resulting in study withdrawal or dose reduction. The study also investigated characteristics associated with better reporting of key AEs and conducted a survey among EORTC members to gauge their expectations on key AEs reporting.
Results
- Grade 3/4 AEs: Reported in 96% of the reports, but only 17% specified the reporting threshold, potentially leading to underreporting of less frequent but important grade 3/4 AEs.
- Grade 5 AEs: Adequately reported in 50% of manuscripts.
- AEs leading to study withdrawal: Reported in 19% of manuscripts.
- AEs leading to dose reduction: Reported in 13% of manuscripts.
In contrast, EORTC members expected comprehensive reporting of grade 5 AEs (96% of responses), AEs leading to study withdrawal (86%), and AEs leading to dose reduction (70%).
Conclusions
The study highlights the variability and sometimes inadequacy in the current practice of key AEs reporting in oncology RCTs. It suggests revising current standards for safety reporting in RCTs to emphasize the importance of comprehensive key AEs reporting.