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

Cole Wayant, Richard Bindernagel, Matt Vassar

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalBMJ Evidence-Based Medicine
DOIs
StateAccepted/In press - 1 Jan 2019

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United States Food and Drug Administration
Checklist
Clinical Trials
Hematology
Compliance
Publications
Appointments and Schedules
Outcome Assessment (Health Care)
Pharmaceutical Preparations

Keywords

  • clinical trials
  • oncology

Cite this

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title = "TIDieR checklist evaluation of clinical trial intervention reporting for recent FDA-approved anticancer medications",
abstract = "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.",
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N2 - 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.

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