TY - JOUR
T1 - TIDieR checklist evaluation of clinical trial intervention reporting for recent FDA-approved anticancer medications
AU - Wayant, Cole
AU - Bindernagel, Richard
AU - Vassar, Matt
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/1/1
Y1 - 2019/1/1
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.
AB - 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.
KW - clinical trials
KW - oncology
UR - http://www.scopus.com/inward/record.url?scp=85074302645&partnerID=8YFLogxK
U2 - 10.1136/bmjebm-2019-111249
DO - 10.1136/bmjebm-2019-111249
M3 - Article
C2 - 31653687
AN - SCOPUS:85074302645
SN - 2515-446X
VL - 25
SP - 97
EP - 101
JO - BMJ Evidence-Based Medicine
JF - BMJ Evidence-Based Medicine
IS - 3
ER -