On 11–12 June 2019, over 60 pharma stakeholders met in Amsterdam at the
8th Annual Publication and Clinical Trial Transparency Conference to discuss the evolving landscape of clinical trial transparency. Conversations covered the fragmented nature of regulatory requirements in Europe and North America, the need for a more integrated approach to the management of disclosures in registries and publications, and the role of transparency initiatives – that have armed transparency advocates within pharma with the tools to drive disclosure levels that go above and beyond the minimum legal requirements.
In October 2018, the UK House of Commons Select Committee claimed that ‘failing to publish data from clinical trials presents risk to human health’. The Trials Tracker transparency tools developed by the Evidence-Based Medicine DataLab at the University of Oxford demonstrate that, in general, large pharma companies have high rates of compliance with transparency requirements, while many small pharma companies and universities are failing to meet the minimum legal requirements.
The Select Committee called for the UK Health Research Authority (HRA) to be provided with funding to establish a national audit programme of clinical trial transparency, with sanctions against non-compliant sponsors to be used to drive improvements. In her presentation, Amanda Hunn, former Joint Head of Policy and Public Affairs at the HRA, suggested that the draft clinical trial transparency strategy, developed by the HRA’s Research Transparency Strategy Group, was imminent. Proposed sanctions may include the withholding of ethics approval for future studies, the withdrawal of ethics approval of ongoing studies and financial penalties. The EU already has the power to impose fines but is yet to do so, despite the fact that only 60.2% of all clinical trials report their results (as of 5 July 2019). It was suggested that if the UK HRA starts to impose sanctions, other EU states will surely follow. Meanwhile, the US Food and Drug Administration Amendment Act (FDAAA) Trials Tracker monitors compliance with the US Food and Drug Administration (FDA) requirement for certain clinical trials to report results within 12 months. Again, despite the threat of financial sanctions, the FDA has, to date, not imposed fines that could total over US$3.5 billion.
Compliance of large pharma companies with reporting requirements is very high as robust processes are in place. Indeed, “only 5–6% of studies from the top-50 pharma companies appear to be missing results”, explained Thomas Wicks of TrialScope. He suggested that the greatest risk of exposure of large pharma companies to sanctions may come from the acquisition of smaller companies or from forming alliances. Collaborating with academic institutions that have poor transparency track records may also pose a problem.
Although the risk of sanctions to large pharma companies is low, it is still essential for them to have a clear picture of clinical trial transparency levels in the industry – the tools such as the trials trackers, the +AllTrials Transparency Index and the
Good Pharma Scorecard offer transparency advocates within pharma a “useful crowbar”, explained Christopher Marshallsay from Grünenthal. Pharma companies care about their image in the eyes of investors, collaborators and the public. Audiences see the large numbers on the transparency platforms and will not attempt to understand the deficiencies in the methodologies used by the tracking platforms in the EU and FDA databases. Pharma companies do not want to be associated with negative numbers and benchmark themselves against other organizations in the industry. “When looking at their peers, they see more and more companies going above and beyond the legal minimum”, reasoned Christopher. Competition over image may also drive a desire in senior management to climb the transparency league tables.
Benchmarking against industry peers is a powerful tool for those looking to drive open science and transparency in their organizations. However, collaborations with like-minded individuals across industry is also essential for progress. We, at Open Pharma, play a pivotal role in facilitating discussions between our members, offering them the chance to build collaborations and develop initiatives to drive greater transparency and innovation.