TIDieR Checklist Evaluation of Clinical Trial Intervention Reporting for Recent FDA-Approved Anticancer Medications
BMJ Evidence-Based Medicine
Importance: Clear 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.
Objective: To determine the quality of reporting of recent Food and Drug Administration (FDA)-approved oncology interventions.
Design: Cross-sectional investigation.
Setting/participants/intervention: Recent, FDA-approved haematology/oncology anticancer interventions.
Main outcome measure: Quality of reporting.
Results: Across 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).
Conclusions: In 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.
clinical trials, oncology
Wayant C, Bindernagel R, Vassar M. TIDieR Checklist Evaluation of Clinical Trial Intervention Reporting for Recent FDA-Approved Anticancer Medications. BMJ Evidence-Based Medicine. 2020; 25(3). doi: 10.1136/bmjebm-2019-111249.