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General Medicine
TIDieR checklist evaluation of clinical trial intervention reporting for recent FDA-approved anticancer medications
  1. Cole Wayant1,
  2. Richard Bindernagel2,
  3. Matt Vassar1
  1. 1Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
  2. 2Kansas City University of Medicine and Biosciences, Kansas City, Missouri, USA
  1. Correspondence to Cole Wayant, Oklahoma State University Center for Health Sciences, Tulsa, OK 74107, USA; cole.wayant{at}okstate.edu

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.

  • oncology
  • clinical trials
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Footnotes

  • Twitter @ColeWayant_OK

  • Contributors CW and MV conceptualized the study. CW and RB extracted and analyzed all data. CW, RB, and MV wrote the manuscript, provided critical feedback, and approve the manuscript in its final form.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository.

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