TY - JOUR
T1 - Improving clinical trial transparency at UK universities
T2 - Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register
AU - Mirjam Keestra, Sarai
AU - Rodgers, Florence
AU - Gepp, Sophie
AU - Grabitz, Peter
AU - Bruckner, Till
N1 - Funding Information: The author(s) received no financial support for the research, authorship and/or publication of this article. Publisher Copyright: © The Author(s) 2022.
PY - 2022/4
Y1 - 2022/4
N2 - Background: January 2019, the House of Commons’ Science and Technology Committee sent letters to UK universities admonishing them to achieve compliance with results reporting requirements for Clinical Trials of Investigative Medicinal Products by summer 2019. This study documents changes in the clinical trial policies and Clinical Trials of Investigative Medicinal Product reporting performance of 20 major UK universities following that intervention. Methods: Freedom of Information requests were filed in June 2018 and June 2020 to obtain clinical trial registration and reporting policies covering both Clinical Trials of Investigative Medicinal Products and all other clinical trials. Two independent reviewers assessed policies against transparency benchmarks based on World Health Organization best practices. To evaluate universities’ trial reporting performance, we used a public online tracking tool, the European Union Trials Tracker, which assesses universities’ compliance with regulatory Clinical Trials of Investigative Medicinal Product disclosure requirements on the European Clinical Trial Register. Specifically, we evaluated whether universities were adhering to the European Union requirement to post summary results on the trial registry within 12 months of completion. Results: Mean policy strength increased from 2.8 to 4.9 points (out of a maximum of 7 points) between June 2018 and June 2020. In October 2018 the average percentage of due Clinical Trials of Investigative Medicinal Products that had results available on the European trial registry across university sponsors included in the cohort was 29%. By June 2021, this had increased to 91%, with 5 universities achieving a reporting performance of 100%. All 20 universities reported more than 70% of their due trial results on the European trial registry. Interpretation: Political pressure appears to have a significant positive impact on UK universities’ clinical trial reporting policies and performance. Similar approaches could be used to improve reporting performance for other types of sponsors, other types of trials, and in other countries.
AB - Background: January 2019, the House of Commons’ Science and Technology Committee sent letters to UK universities admonishing them to achieve compliance with results reporting requirements for Clinical Trials of Investigative Medicinal Products by summer 2019. This study documents changes in the clinical trial policies and Clinical Trials of Investigative Medicinal Product reporting performance of 20 major UK universities following that intervention. Methods: Freedom of Information requests were filed in June 2018 and June 2020 to obtain clinical trial registration and reporting policies covering both Clinical Trials of Investigative Medicinal Products and all other clinical trials. Two independent reviewers assessed policies against transparency benchmarks based on World Health Organization best practices. To evaluate universities’ trial reporting performance, we used a public online tracking tool, the European Union Trials Tracker, which assesses universities’ compliance with regulatory Clinical Trials of Investigative Medicinal Product disclosure requirements on the European Clinical Trial Register. Specifically, we evaluated whether universities were adhering to the European Union requirement to post summary results on the trial registry within 12 months of completion. Results: Mean policy strength increased from 2.8 to 4.9 points (out of a maximum of 7 points) between June 2018 and June 2020. In October 2018 the average percentage of due Clinical Trials of Investigative Medicinal Products that had results available on the European trial registry across university sponsors included in the cohort was 29%. By June 2021, this had increased to 91%, with 5 universities achieving a reporting performance of 100%. All 20 universities reported more than 70% of their due trial results on the European trial registry. Interpretation: Political pressure appears to have a significant positive impact on UK universities’ clinical trial reporting policies and performance. Similar approaches could be used to improve reporting performance for other types of sponsors, other types of trials, and in other countries.
KW - Clinical trial transparency
KW - missing trial results
KW - publication bias
KW - research governance
KW - research waste
KW - universities
UR - http://www.scopus.com/inward/record.url?scp=85125080709&partnerID=8YFLogxK
U2 - https://doi.org/10.1177/17407745211071015
DO - https://doi.org/10.1177/17407745211071015
M3 - Article
C2 - 35168372
SN - 1740-7745
VL - 19
SP - 217
EP - 223
JO - Clinical trials (London, England)
JF - Clinical trials (London, England)
IS - 2
ER -