It's time the industry spoke out about legal challenge to clinical trial transparency
The judicial review brought by Richmond Pharmacology against the Health Research Authority – erroneous, a waste of public money and if left unchallenged by the biopharmaceutical industry, hugely damaging to it.
This story has been covered by Pharmafocus and the national press. Each time I read about it, my level of incredulity about Richmond Pharmacology’s action increases, as does my concern that the biopharmaceutical industry seems oblivious to the damage to its constantly battered public reputation, and that leaving this issue unchallenged could do.
Let’s be clear. This is about clinical trial registration only. The Health Research Authority (HRA) has developed a very clear and well thought-through transparency policy which is based on a requirement for all sponsors of clinical research, commercial or non-commercial, to register their studies publicly.
It is also has a clear set of Q&A’s available on its website. These address most, if not all, of the concerns that a sponsor might have with regard to commercial-in-confidence or UK competitiveness issues.
For example, a CRO such as Richmond Pharmacology will naturally be conducting studies in their very earliest clinical phases and, so there may sometimes be legitimate ‘commercial in confidence’ concerns for the sponsor to register a trial at the time of its conduct on public database.
Similarly, such studies might well be contributing to UK competitiveness, so I can also see that there might be sensitivities in relation to the early registration of the trials. However, the HRA recognises both these issues and has described a simple deferral of registration process as part of its transparency plans.
The press coverage also claimed that HRA’s plans “include a requirement on those running trials to ensure all previous studies they were involved in have also been registered”. However looking at things pragmatically, it would be a well-nigh impossible task for most companies to register all the trials they have conducted, because, people move around and companies are constantly subject to merger and acquisition. Again, the HRA understands this point, which is why they’re limiting retrospective registration, or notice of deferral of registration, to trials that are still in active recruitment in the UK.
Frankly, another puzzle is why Richmond Pharmacology, as a single contract research organisation, has chosen to challenge the HRA in the courts. As the organisation that’s ultimately responsible for trial conduct, it is the sponsor company’s responsibility to register trials, not the organisation that is conducting them on their behalf. Neither can a CRO legitimately call itself a biopharmaceutical company or act as the industry’s representative voice – which is how this story is being portrayed in some sections of the media and by the industry’s critics.
At face value therefore, this challenge to HRA’s very well thought-through plans seems very misguided and a colossal waste of public money. Richmond Pharmacology’s action cannot in any way be taken to reflect the views of the research-based biopharmaceutical industry as a whole. Indeed, if left unchallenged, it could be extremely damaging to it.
This is an industry in which I’ve proudly spent 23 years of my career as a medically-trained doctor. The vast majority of scientists in industry support a balanced and well managed approach to transparency, as it will be of benefit to all stakeholders in health research.
What makes this action by Richmond Pharmacology even worse is that it is detracting precious resource from the HRA that would otherwise be focussed on the prosecution of its critical work to establish a process for a single ethics and NHS R&D approval for clinical research in England. In terms of enhancing clinical research set-up timelines, this by itself is perhaps the most truly transformative initiative ever undertaken and must be enabled to proceed without unnecessary hindrance.
Therefore, I hope that other colleagues in industry will join me in supporting the HRA’s pivotal work, all well-designed transparency initiatives and challenge the basis of this judicial review.
Dr Mark Edwards is R&D director of EMIG, the trade association for biopharmaceutical SMEs in the UK. He has spent 23 years working in the industry and was formerly a clinical director and head of science and medical public affairs at Pfizer.