TY - JOUR
T1 - Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov-evaluation of a new tracking tool for the US clinical trial registry
AU - Keestra, Sarai Mirjam
AU - Rodgers, Florence
AU - Lenz, Daphne
AU - Osborne, Rhiannon
AU - Bruckner, Till
AU - Lee, Sean
N1 - Funding Information: We are grateful for the help of Bishow Bekhyat Karki in the manual validation of earlier versions of the US clinical-trials-tracker. We also want to thank Nick DeVito from the Evidence-Based Medicine DataLab at the University of Oxford for his advice in developing the novel tracking tool and for his comments on earlier versions of this manuscript. Finally, we want to express our gratitude for Toby Pepperrell?s proofreading of the manuscript. Publisher Copyright: © 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017-2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry ( ClinicalTrials.gov ). Firstly, we developed and evaluated a novel automated tracking tool ( clinical-trials-tracker.com ) for clinical trials registered on ClinicalTrials.gov . This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov . The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov : (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions' reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.
AB - Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017-2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry ( ClinicalTrials.gov ). Firstly, we developed and evaluated a novel automated tracking tool ( clinical-trials-tracker.com ) for clinical trials registered on ClinicalTrials.gov . This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov . The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov : (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions' reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.
KW - Clinical trials
KW - ClinicalTrials.gov
KW - FDAAA 2007
KW - Publication bias
KW - Research waste
KW - Tracking tool
KW - Transparency
UR - http://www.scopus.com/inward/record.url?scp=85107334166&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-021-05330-5
DO - https://doi.org/10.1186/s13063-021-05330-5
M3 - Article
C2 - 34074329
SN - 1745-6215
VL - 22
SP - 375
JO - Trials
JF - Trials
IS - 1
M1 - 375
ER -