Business

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……

This week, patients got a couple more options for finding out about clinical trials they can take part in.

Patientslikeme (which was launched in the United States a few years ago) has unveiled its new new clinical trials site which you can find here.   Patientslikeme is capturing a lot of attention here in the UK and one can see why.  Although this is still very much a first generation clinical trials site for so-called ‘willing patients,’ I like how it presents options and choices. Its interoperability with other parts of the Patientslikeme site (including the option to join other patients online) is also to be commended.  It is well worth a look.

Meanwhile in the States a new site called Reg4All has been launched by the non-profit Genetic Alliance (not to be confused with the UK’s own Genetic Alliance).  This one’s a register, inviting you to join others online and share as much as your personal health information as you so wish, to ‘help spark health innovation for all.’  It’s interesting how heavily they plug patient confidentiality with the privacy controls reported as being ‘unprecedented.’  Other than not signing-up at all of course.

Don’t forget there is also the Government’s very own UK Clinical Trials Gateway (UKCTG) whose future development I am very involved in, as well as ClinicalResearch.com,  TrialReach, HealthUnlocked, YourTreatmentChoices .  Funny how almost all of these sites miss out the spaces between the words in their titles isn’t it?  I wonder what that is all about.

 

Anyway, the market of organisations competing for the attention of patients entering clinical trials gets busier by the day.  This seems a healthy thing to me on the one hand.  On the other, I feel patients will want to see a ‘coming together’ at some point.  Although not necessarily in the way that you might assume; it might take many forms in fact.

Agreement on some common principles and standards for how to operate as in the manner of a learning health system (there are some interesting precedents in the US for this with respect to data use)? Partnership, merger or co-operation?  Perhaps formal regulation (by the Health Research Authority)?  But, most of all, integration with their care and treatment in the NHS and how this is provided.  There will also be a growing demand public involvement in how they work; more than any of the above providers can currently demonstrate.  Also,demands for reassurances over the ‘patient experience,’ with the AllTrials agenda just the tip of the iceberg in how I predict people will increasingly set higher expectations with clinical trial providers, and those who recruit on their behalf, before signing the consent form.

Finally, here is a brief interview with Scotland’s Chief Scientist, Dr Andrew Morris.  He talks about the importance of research being integrated into NHS care and treatment if we are to grow cohorts of patients who are active in research and the building of systems that enables that.  He references the well-known DART initiative in Scotland involving 7000+ people with diabetes.

I’m off to watch the rugby now.

The Organisation for Economic Co-operation and Development (OECD) yesterday waded into the increasingly feverish debate about the regulation of clinical trials with a strongly worded recommendation calling on its members to harmonise approval processes.  The recommendation which is worded with the minimum of fuss, is backed by a more detailed explanatory memorandum.

But I am disappointed that the specific recommendation on public involvement from the OECD Global Forum on clinical trials  in October 2011 has not been carried through to inclusion in the documents issued yesterday.  As far as I can see anyway. The Forum had stated the following:

C.3 Increase patient involvement in clinical-trial processes
More direct involvement of patients in the design and monitoring of clinical trials – as well as
their contribution to improve the quality, safety and relevance of clinical research – is of
critical significance for the success and impact of clinical science as a whole.
The roles of patients in clinical trials should be strengthened by means of:
 Mandatory participation of a representative of patients’ opinion in ethics committees
(as such, they would be involved in the decision regarding future risk categories of
clinical trials).
 Consultative and participative role in the planning, design, conduct, dissemination
and implementation of results from clinical science, in part mediated through the
activities of the global networks as well as their regional and local network members
and through other relevant channels.
 Simplified informed-consent documents, containing the vital information for decision
making, using shorter and pedagogically sound explanations.
 Accessible information, for patients, families and the general public. This should
include educational websites, ad hoc documents and open dialogue sessions with
clinical staff at the hospital/clinical unit level, and transparent access to clinical
registers and information databases about planned, ongoing and completed clinical
trials by regulatory authorities.

I’ll do a bit of follow-up and report back!

The European Medicines Agency (EMA) has published the note of the conference held in London a few weeks ago, about its plans for proactive publication of clinical trial data.

It is now setting up five advisory groups and inviting self-nominations from people to join these.  You will find the following listing of the advisory groups, plus a form to fill out if you wish to put yourself forward, by going to this link.  But I thought it would be helpful to cut-and-paste the descriptions of the groups as on the website.

Advisory group Topics
Protecting patient confidentiality How can the Agency ensure through its policy that patient and other personal information will be adequately protected, i.e. that patients cannot be retroactively identified when clinical-trial data are released, and that applicable legislation, standards, and rules regarding personal data protection will be respected?
Clinical-trial-data formats How can the Agency ensure through its policy that clinical-trial data can be shared, in the interests of public health, in a clear and understandable format that enables appropriate analyses and a swift implementation without undue burden to stakeholders?
Rules of engagement Are there rules or conditions that should be in place before an external stakeholder can download clinical-trial data (e.g. formal acceptance of the need to respect personal data rules, uploading of analysis plans etc.)?
Good analysis practice Are there good-analysis-practice guidelines that the Agency could ask external requestors of data to consider or be aware of, and that the Agency can apply when confronted with additional analyses from external parties?
Legal aspects Are there any legal aspects other than personal data protection that need to be addressed when drafting the Agency’s policy? Are there exceptional circumstances under which data can be claimed to be commercially confidential?

First, a brief history of time in the Europe Union (EU).

It goes slowly.

That’s it!

For the last two years or so the European Commission has been consulting on plans to revise the European Clinical Trials Directive.  The Directive has been in force since 2001.  Researchers hate it.  To be fair so do many patient organisations.   The main complaint is that it slows down research into new drugs particularly in swotty Britain where we tend to do everything by the book and then bind it in gold leaf.  That’s probably because of a) our schooling, b) we are brought up as subjects and, c) because of the same tendencies that make us enjoy queuing (select  from the above as you see fit).

Over the summer the Commission published a draft proposal for new legislation or ‘Regulation’  for consultation and it is being considered by the European Parliament.  Cue the usual confetti of responses from organisations and alliances of organisations stating what they do and don’t like.  My basic summation of these responses thus far is that they think it’s much better because they won’t need any more gold leaf.

Last Thursday, the European Public Health Alliance (EPHA) – an association of non-governmental organisations from across Europe – issued its own revised policy position.  It is to be applauded for being the only one I have seen this far which pushes the Commission hard to consider certain aspects of growing importance to patients in trials:  the right to clear information; openness and transparency, and public involvement in all aspects of clinical trials.  The following para taken from their website gives you a taster:

‘From this perspective it is also vital that clinical trials reflect the populations that are meant to benefit from them – for example women, older people and ethnic minorities – and that access to clinical trial data and reports is as open and transparent as possible, which implies full public disclosure in a central database to protect public health interests. Moreover, patients’ involvement in the process is essential; while this is foreseen in the present proposal, the extent to which patients will be able to influence the process still requires clarification.’

By contrast, this statement issued by UK commercial and non-commercial organisations could, and should, have taken a much stronger line on public involvement than it does.  Particularly given many of the signatories, a number of  whom I admire greatly and are highly supportive of the agenda.  But public involvement is only really mentioned in reference to the Regulation’s proposed panel for reviewing trials.  Such documents – jointly written and needing to be agreed by many – are often a difficult compromise.  But this one does leave the impression that research is the dominant force, spinning a golden thread of ‘we know best.’

The UK has often set the international standard for public involvement in health research.  So I hope this is not one of those examples of our country going to sleep on the job only to wake up and find that our European neighbours are way ahead of us.  As I say, time passes slowly in Europe but not when you are asleep.

Current Controlled Trials (CCT), which aims ‘to increase the availability, and promote the exchange, of information
about ongoing randomised controlled trials worldwide,’ has appointed a new advisory board to help it in its work.  Other than yours truly, the Board includes Ben Goldacre and Paul Wicks (PatientsLikeMe) among its members, and is drawing on international expertise as well.

This is a really impressive operation with real ambitions to innovate and improve the information on trials that is available to professionals and the public.  So you might want to bookmark their blog or become a follower to stay up-to-date with new developments.

I feel rather honoured to have been asked to join and am very excited about getting down to work.