Is there room for improvement in adverse event reporting in the era of targeted therapies?
The Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, and its predecessors, the Common Toxicity Criteria (CTC) versions 1.0 and 2.0, were developed under the direction of the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI) in an effort to provide standard language for reporting adverse events that occur in NCI-sponsored clinical trials. Each successive version of the CTC has improved the accuracy, precision, and completeness of the criteria in an effort to standardize reporting. We believe that the current version of the CTCAE cannot adequately code the subacute adverse events that commonly occur with today's targeted therapies.
Edgerly
Maureen
M
Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Fojo
Tito
T
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D012107:Research Design / Q000639:trends; D011795:Surveys and Questionnaires; D014481:United States
D000970:Antineoplastic Agents