Adverse Events Reporting in Oncology Studies Suboptimal

February 2014 Vol 7, No 1, Special Issue ASH 2013 Payers' Perspectives in Oncology - FDA Approvals

Transparent and comprehensive reporting of adverse events (AEs) in published results of oncology-related clinical trials is crucial for the treatment of patients with cancer. The Consolidated Standards of Reporting Trials (CONSORT) extension group had developed 10 recommendations in 2003 for reporting AEs. A new analysis of 175 publications recently assessed the degree to which the publication of phase 3 trial results in oncology adhered with CONSORT recommendations (Sivendran S, et al. J Clin Oncol. 2014;32:83-89).

Based on this analysis, the published reports of AEs is suboptimal and is characterized by significant selectivity of the data. The analysis involved randomized, phase 3 clinical trials in metastatic solid malignancies published between January 2009 and December 2011. Publications were assessed for 14 AEs listed in the CONSORT harms extension statement, using a completeness score of 0 to 14.

Data on 96,125 patients were included. The median completeness score was 8. The majority of publications (96%) only reported AEs above a particular threshold rate or severity. Overall, 37% did not specify the criteria used to report AEs, and 88% grouped AEs of varying severity.

Only 77% of articles reported absolute numbers of AEs, 75% reported if there were deaths related to AEs, 71% reported whether patients were evaluable for toxicity, and 65% reported reasons for treatment discontinuation.

In addition, trials without a specified funding source were associated with significantly lower AE complete reporting scores.

This analysis shows substantial selectivity in the reporting of AEs in oncology publications.

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Last modified: March 4, 2014
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