In April 2023, TranspariMED reported that British Heart Foundation (BHF) guidelines for researchers conducting clinical trials met 7 out of 11 of the WHO Best Practices in Clinical Trial Transparency. BHF is the biggest independent funder of cardiovascular research in the UK, and we are committed to encouraging best practice in this area. As part of assessing our policies and to gain insight on areas for improvement, we are starting to review compliance with our trial transparency guidelines on an annual basis.
BHF policies on clinical trial registration and reporting were first formalised on our website in 2017, but we have not previously reviewed compliance with our transparency policies in a systematic way. This first review includes clinical trials supported by our Clinical Study Grant and Special Project Grant funding schemes between the 2010/2011 and 2022/2023 financial years.
BHF has funded 45 clinical trials, with a combined grant value of £52.6 million, through these schemes during this period.
Our key findings are summarised below – view the full report for more details, including how the review was carried out.
BHF expects that the clinical trials we fund are prospectively registered (before the first participant is recruited) in a publicly available database. Of 36 clinical trials that have completed or have started recruiting participants as of 31/03/2023, we found that 100% are registered, with 78% (28/36) having been registered prospectively. Prospective registration seems to be increasing over time - 73% (19/26) of trials funded prior to 2017 were registered prospectively; compared with 90% (9/10) of more recently funded trials.
Disclosing summary results
BHF expects that summary clinical trial results are publicly reported within 12 months of primary study completion (the last data collection time point for the last subject for the primary outcome measure). Of 18 trials that completed at least 12 months prior to 31/03/2023, 61% (11/18) reported summary results within 12 months of study completion. We found that 28% (5/18) reported summary results >12 months after study completion, and 11% (2/18) that completed between 12 and 24 months ago have not yet reported summary results.
BHF expects that the primary results of a clinical trial are published in a peer-reviewed journal or platform within 24 months of primary study completion. Of 14 trials that completed at least 24 months prior to 31/03/2023, 100% had results published in a peer-reviewed journal, with 86% (12/14) publishing within 24 months of study completion. 14% (2/14) published primary results >24 months after study completion.
This review provides a baseline assessment of compliance with BHF’s trial registration and reporting guidelines. BHF will continue to review transparency practices of the trials we fund each year.
We are pleased that a high percentage of BHF-funded trials are registered prospectively – but moving forward, we will endeavour to ensure this is the case for all trials we fund (e.g., by reminding trial teams at the point of grant activation).
Disclosure of results is an area where we would like to see improvement on the next review, particularly as the UK government is set to introduce a legal requirement for clinical trial results to be made publicly available within 12 months of trial completion. While we recognise that the timeframe within which a study is published in a peer-reviewed journal is not within the complete control of research teams, this should not prevent a summary of results being made publicly available in a timely manner.
To this end, we have amended our policies to stipulate that we expect summary results to be posted on the trial registry within 12 months of primary study completion (in line with WHO guidelines). Posting trial results to registries is typically much faster than publishing in an academic journal, and importantly doing so does not prevent the results from being subsequently published in a journal.
We will be following up with individual trial teams to ensure that summary results are made available on the registry, and to better understand any barriers to compliance with our transparency guidelines. In addition, we will continue to share lay summaries of the findings of BHF-funded trials on our website as results become available.
This guest blog was written by Dr Phoebe Kitscha, Research Advisor at the British Heart Foundation, a UK nonprofit that funds around £100 million of research each year into all heart and circulatory diseases and the things that cause them. BHF’s full transparency report can be accessed online. A similar transparency report by a different UK charity is discussed here.