Not for the first time I was awake at 3am this morning. Cup of tea in hand, watching American football. It’s amazing how those players keep the ball when so many other players are piling on top of them. Rarely do you see the thing break free. They must practice for hours….
The House of Commons Science and Technology Select Committee has this morning published the report of its inquiry into clinical trials .
The overall thrust of the report and its recommendations has been welcomed by those who have been calling for greater transparency in this area. Not least the ‘AllTrials’ coalition who have spearheaded this campaign and whose public petition is approaching 60,000 signatures (see link at foot of this page if you wish to sign).
Those on the other side of the debate have been somewhat quieter. I wonder whether this reflects their sense that they have got off more lightly than might have been expected when the inquiry was launched in 2012. It could mean the reverse of course. But, from my perspective, I would make three observations.
- It is a shame that this inquiry – which is at the end of the day about research largely involving patients and aimed at improving people’s health – was not steered by the Health Select Committee or had some involvement from them perhaps in a joint session. It means we have a report that is fundamentally about the scientific process. Debate about such processes and their complexities are a safe haven for funders who like to say: ‘You wouldn’t understand’ just a bit too often for my liking. It is true that the report clearly references the importance of transparency to patient safety. But I would like to have seen more exploration of the first principles for why we do this sort of research in the first place.
- Also, despite receiving written and oral evidence on the subject, the Committee did not acknowledge or recognise the importance of involving the public in trial design and delivery. This partnership can help to address some of the issues around ethics and process that professional colleagues struggle with. It does not even recommend a wider dialogue with patients and the public about how some of these challenges might be overcome. Which is odd given the increasing numbers of people going into trails and the importance of the public confidence factor in sustaining the clinical research sector going forwards.
- So, as a result, the report does not address the transparency issue sufficiently from a patient perspective in my view. I am disappointed that the Committee does not recommend all research participants should be informed about the results of a trial they have taken part in. Or embrace some of the questions Ben Goldacre encourages patients to ask in his book ‘Bad Pharma.’ Nor does it consider how access to clinical trial data might actually be a powerful tool for patients in the future in understanding and making decisions about their own individual care and treatment. We really do need to pull the debate away from the limitations and faults of the current system to a consideration of future possibilities.
- Lastly, I am fascinated that the Committee aims the vast majority of its recommendations and some of its heaviest criticism at Government. Funny how the health research ecosystem that funders love to champion going into a spending review, breaks down when there might be a suggestion of them taking on greater liabilities and responsibilities. Yes, Government sets the regulatory framework. But funders should be doing this because it is the right thing to do. The Committee, in my personal opinion, should have said this more strongly; after all Andrew Witty from GSK was happy to say so many months ago. Fundamentally, the Committee could and should have placed greater responsibility at the door of industry and charities for both a) laying down requirements around transparency with those they fund and have funded for the last umpteen decades and b) monitoring compliance. Neither sector in the whole is short of money to do this.
Yes, for these reasons, the ball skidded away on the wet grass for me.
And sorry, I think it laughable that any company or science establishment is still in business who has bothered to give evidence to a Committee but claims not to have heard of the Health Research Authority (HRA). They are clearly not paying their public affairs consultancy nearly enough.
On the positive side, I am delighted that the Committee signals its strong support for efforts to encourage more people to participate in clinical research including ‘Ok to Ask,’ and to strengthen and improve the UK Clinical Trials Gateway (UKCTG). It also comes up with some helpful and challenging critique for how both might be done. The committee discusses these aspects on pages 23-29 of its report. Somewhere in the appendix you can find a transcript of my oral evidence.
And a reminder that the writings on this blog, are as always, a personal view……
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