The Association of the British Pharmaceutical Industry (ABPI) identifies “high standards for transparency” as one of seven key factors required to maintain the UK’s position as an "attractive destination for global investment in the sector".
According to a new policy paper published by ABPI:
“A key element of research transparency is registration and reporting on international databases and registries, in a timely manner, as governed by UK and EU legislation. In the UK, the Health Research Authority (HRA) ensures that those conducting research across non-commercial, charity and commercial clinical trials, comply with these regulations.”
[TranspariMED comment: While the HRA should be ensuring this in theory, many clinical trials conducted in the UK are still not being registered and/or fail to make their results public. For this reason, Parliament and a coalition of twelve patient and integrity groups including TranspariMED have called for the introduction of sanctions with teeth.]
The ABPI paper continues to argue that:
“To achieve greater clinical trial transparency, the HRA’s draft strategy, proposes how it can improve registration and reporting in clinical research. ABPI supports this draft strategy and continues to work with the HRA to improve transparency in commercial clinical trials. Any UK specific initiatives should be practical to implement and not duplicate work for clinical trial sponsors.
In addition, any UK initiatives should be in line with international standards such as the WHO standards for clinical trial registries. Once made available, research should be accessible, through user-friendly registries and databases, and open access journals where research findings do not sit behind pay walls.”
Several large pharma companies in the UK, notably GlaxoSmithKline, have over the years gained a reputation for outperforming their global peers in terms of clinical trial transparency. Worldwide, large pharma companies have significantly improved their track record on timely reporting of trial results on registries in particular.
However, compliance with regulatory requirements to disclose trial results by medium-sized and smaller companies in both Europe and the United States remains poor. TranspariMED is not aware of any comparable data on the performance of smaller commercial players specifically in the UK.
ABPI’s paper also includes an overview of commercial drug trial activity in key countries:
Only commercial trials related to pharmaceutical drug development and molecular/biological entities are included in the data above. Thus, the data excludes all trials of trials of medical devices and non-drug treatments, and all trials run by nonprofits, universities, and government institutions.
To find out more about why clinical trial transparency is so important, see this presentation and this background paper.