How did UK institutions improve clinical trial transparency? – new study
A new study outlines how institutions can improve clinical trial transparency, based on interviews with 14 research governance and trial management staff from UK universities and NHS Trusts.
Key takeaways below.
How institutions improved transparency
External pressure: Impetus for transparency has been generated by a combination of political pressure, regulatory inspections, and monitoring and advocacy activities by external groups.
Key steps: Measures taken by institutions include setting out clear expectations, signposting to strong policies and SOPs, support systems for investigators, sending reminders and the creation of specific escalation pathways.
Systematic oversight: “Increased oversight of trial portfolios through more robust record keeping and consistent contact with study teams was often mentioned as an important process improvement. Older trials, that were not closely tracked, were often difficult to follow-up due to incorrect assignment of sponsorship responsibilities, loss of data, and researchers leaving the institution.”
Access to know-how: Several professional networks provided valuable sources of information and best practice.
Typically, trialists within UK institutions seem to input data into clinical trial registries themselves:
“Research offices explicitly did not own the process of interacting with registry entries and uploading results. They often controlled access to institutional registry accounts but only one respondent indicated that their staff actually inputs results directly to the registry on behalf of the research team. Outside of rare instances requiring special assistance, respondents felt that this responsibility should sit with the research teams as they have direct access to the data, understanding of the technical study details, and direct ownership of responsibility for the trial. The research office role was to provide support and oversight.”
Barriers and challenges
Limited resources: “One respondent expressed concern about whether increases in national requirements and attention to transparency issues would be matched by increased investment in already strained research offices… As funding typically ended with the trial, key staff like trial managers were not typically available, or forced to contribute time outside of their current projects, to aid investigators in ensuring trials are reported.”
Gaps in oversight: The resources of research offices are directed towards those trials that are most closely regulated and tracked (CTIMPs). “This left respondents less confident that best practice around registration and reporting was being followed for non-CTIMPs trials (e.g, device, surgical, etc.). Improving the oversight of these areas was sometimes referenced as an area for future improvement.”
User friendliness of registries: The ISRCTN trial registry was praised as being far more user friendly than the European drug trial registry EudraCT. One respondent described ClinicalTrials.gov as “clunky”.
Multiple registrations: “Single trials registered across multiple registries, sometimes unavoidable due to regulations, was seen as particularly problematic for oversight.”
Lack of clarity about the rules: In the past, there had been confusion among staff at one institution as to whether prospective registration was required, or merely recommended, leading to the resulting publication being rejected by a major journal.
Conclusions
Adequate funding required: “Investment in the institutional governance of transparency is essential to achieving more optimal transparency practice, including the use of registries.”
Lessons are transferable: “The lessons learned from UK sponsors provide a template that can be adapted to aid in improving the transparency of non-commercial sponsors in other contexts.”
TranspariMED has created a collection of useful tools and resources that institutions can use to improve their trial registration and reporting.
The study “Barriers and Best Practices to Improving Clinical Trials Transparency at UK Public Research Institutions: A qualitative interview study” was published open access in a peer reviewed journal.