Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register

Abstract

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.

Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center

“…For example, the launch of the EU Trials Tracker as a public audit tool was complemented by an advocacy campaign, which eventually spurred policymakers and other stakeholders to demand change from institutions (Lamb, 2019). Research performing institutions subsequently rapidly improved their capacities to address these practices, and within a few years, universities policies had been strengthened (Keestra et al, 2022), and trial reporting increased from 50% in 2018 to 84% in September 2023 (Bennett Institute for Applied Data Science, n.d.). Additional external factors further reinforced opportunity: in February 2020, the Make It Public strategy was adopted in the United Kingdom, whereby clinical trials are automatically and centrally registered by the Health Research Authority following ethics approval, which saves researchers this extra step (Health Research Authority, 2020).…”

“…For example, the launch of the EU Trials Tracker as a public audit tool was complemented by an advocacy campaign, which eventually spurred policymakers and other stakeholders to demand change from institutions (Lamb, 2019). Research performing institutions subsequently rapidly improved their capacities to address these practices, and within a few years, universities policies had been strengthened (Keestra et al, 2022) In the United States, efforts to understand existing support structures for trial registration and reporting (Mayo-Wilson et al, 2018) were accompanied by improvements in transparency at academic organizations. Institutional programs to support compliance with registration and reporting requirements launched a variety of activities, including audits to identify problem records and bring them into compliance, prospective reminders, policy development, enforcement, standard operating procedures, centralized resources, training, and consultation (Keyes et al, 2021;O'Reilly et al, 2015;Snider et al, 2020).…”