Subscribe

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.

Related Items
Opdivo plus Yervoy and Limited Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
Web Exclusives published on June 1, 2020 in FDA Approvals, Lung Cancer
Tecentriq plus Avastin First Immunotherapy Regimen Approved for Metastatic Hepatocellular Carcinoma
Web Exclusives published on June 1, 2020 in FDA Approvals, Lung Cancer
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Approvals, Prostate Cancer
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
Web Exclusives published on May 26, 2020 in FDA Approvals, Lung Cancer
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
Web Exclusives published on May 18, 2020 in FDA Approvals, Lung Cancer
Last modified: March 4, 2014
Copyright © Engage Healthcare Communications, LLC. All rights reserved.