High Court rules that Health Research Authority acted unlawfully over trial transparency

Dear Editor - We thank the author for this well researched article.

The recent judgement about the HRA’s transparency policy for clinical trials makes it clear that Richmond was justified in asking for clear rules, to settle some of the conflicting interests that can arise between commerce and medical science. The previous HRA position was unhelpful; it had retrospective requirements, impossible to fulfil, and which would make the UK a no-go area for an international sponsor of clinical research. Sponsors would have looked and seen that the HRA’s requirements were unclear, uncertain and limitless in time and geography. Sponsors can take their clinical research elsewhere: that would be a scientific and economic loss to the UK and it would be unwanted for patients too, because we believe that standards in the UK can be excellent in their protection of patients and good science.

For sponsors and innovators who develop new potential medicines, there is a financial incentive for secrecy; it makes patenting possible, since any prior publication prevents a patent. Some mechanisms need to be put in place to give parties sufficient but limited time to apply for a patent, before being required to make trial procedures and results public. This is particularly important for Phase 1 clinical trials as they are basic research and not intended to produce immediate benefit to patients.

Nevertheless, even during Phase 1 trials there may be unexpected adverse effects. There may also be assessments and trial designs that do not produce useful results. In such situations some sponsors or innovators may be tempted towards not publishing, since competitors would gain by learning not to waste resources on ultimately futile developments or methods. The result can be suppression of information of real medical interest. These are circumstances where scientific and medical researchers may be put into a real ethical dilemma between their promise of confidentiality to sponsors, their own competitive commercial or academic interests and their professional ethics.

For a contract research organisation like Richmond, transparency and publication are in our interest, as well as in accord with our ethical standards. They make us known as competent clinical researchers and we are all in favour of publication, as our record shows. Secrecy does us no good at all. Any innuendos that we are against openness is just the sound of dogs barking up the wrong tree.

Finally, your article raises the very important point of the new EU Clinical Trials Regulation’s (CTR) transparency rules1, 2. We would like to share two proposals on their implementation with the BMJ’s readership. Firstly, the HRA currently allows deferral of publicly accessible registration of Phase 1 trials for an undefined period. The deferral is entirely at the discretion of the HRA and no rules have been shared. The HRA thereby takes control over sponsors’ intellectual property. We suggest that this obscurity be solved by the HRA publicly declaring that all deferrals will end on implementation of CTR and that publication will be in accordance with the regulation’s rules.

Secondly, the CTR requires publication of summary reports of clinical trial results. The lay summary report is the most difficult report to write as it needs to translate complex issues completely and accurately into easily understandable language. We propose that summary reports should be based on peer-reviewed manuscripts. This will be the most effective and traceable method of ensuring appropriate standards and content.

1 REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
2 Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014