TIDieR checklist evaluation of clinical trial intervention reporting for recent FDA-approved anticancer medications

Abstract

ImportanceClear and comprehensive descriptions of clinical trial interventions are necessary to translate new results into clinical practice. The TIDieR checklist was developed to be a minimum set of key items considered essential to high-quality reporting of clinical trial interventions.ObjectiveTo determine the quality of reporting of recent Food and Drug Administration (FDA)-approved oncology interventions.DesignCross-sectional investigation.Setting/Participants/InterventionRecent, FDA-approved haematology/oncology anticancer interventions.Main outcome measureQuality of reporting.ResultsAcross all included trials (n=96), a median of 8–9 (out of 12) TIDieR items were reported. Seven TIDieR items had >90% adherence, including individual-level and study-level modifications of drugs and dosing schedules. Three items were less often reported: intervention provider, including training and expertise (7/192, 3.6%); trial institution infrastructure (0/192, 0.0%); and how intervention compliance was assessed (59/192, 30.7%). Publication of a protocol improved intervention reporting (p<0.001).ConclusionsIn this analysis of clinical trials of recent, FDA-approved anticancer interventions, we found good adherence to the TIDieR checklist. These studies were homogeneous in their structure and included information; some TIDieR items were always or never/rarely reported. Clinical trial effect sizes may not translate to real-world practice for a number of reasons. Thus, to aid the translation of trial effect sizes to real-world practice, we recommend authors adhere to the TIDieR checklist and describe the infrastructure of trial centres and describe who provided the intervention, along with their expertise.