The Quality of Reporting Harms-Related Data in Clinical Trials of Adjuvant Trastuzumab in Early-Stage Breast Cancer Treatment

• Published in: Therapeutic innovation & regulatory science Vol. 48; no. 3; pp. 299 - 304
• Main Authors: Mahinbakht, Ali, Lavasani, Sayeh M., Guirguis, Micheal
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.05.2014; Springer International Publishing; Springer Nature B.V
• Subjects: Breast cancer; Cancer therapies; Drug Safety and Pharmacovigilance; Drug therapy; Pharmacotherapy; Pharmacy; Safety; Studies; trastuzumab; harm data; breast cancer; CONSORT; adjuvant
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1177/2168479013509383

Randomized controlled trials (RCTs) usually place less emphasis on the harmful effects than on the efficacy of interventions. The 10 CONSORT (Consolidated Standards of Reporting Trials) recommendations for harms reporting aim to improve harms data reporting of RCTs. The aim of this study was to assess the reporting of harms data in adjuvant trastuzumab studies in early-stage breast cancer. The resources PubMed, Cochrane Library, the American Society of Clinical Oncology, and the San Antonio Breast Cancer Symposium were searched for relevant RCTs that met the eligibility criteria. Each RCT was reviewed to determine whether the reporting of data complied with the 10 CONSORT recommendations for harms reporting, and the frequency of compliance with each CONSORT recommendation criterion was reviewed. Five RCTs met the eligibility criteria. Overall, selected RCTs failed to adhere to CONSORT recommendations in all sections of reporting. These results suggest that there is a need to standardize harms data reporting.