Biotechnology and Pharmaceuticals

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!

Earlier this week Patient View published the results of its annual tracker of the pharmaceutical industry’s reputation among patient groups.

The latest study surveyed 600 patient groups (72% of them from Europe). As well as asking patient groups to rank 29 pharmaceutical companies by various indices (such as whether their practices were patient-centred) – Lundbeck came top – they were also invited to comment on the overall reputation of the sector.

Only 34% of the patient groups said that the industry’s reputation was ‘excellent’ or ‘good’ in 2012.  This is down from 42% in 2011.  40% said that it had actually declined and 48% cited the industry’s poor record for transparency as a reason.  Patient View’s report also notes the concerns expressed by patient groups over company practices with regard to the reporting of clinical trial.

Last Friday I spoke to a packed hall of researchers, clinicians and patients at the Berkshire Healthcare Research Collaboration.  The first question from the floor was from a patient and it was on this very subject of transparency.  Myself and other speakers were also pigeon-holed on the subject by other attendees at the close of the session.  The same has been true at many other meetings I have spoken at over the last few months.  Meanwhile the AllTrials petition numbers climb steadily past 8000.

I’ll let you draw your own conclusions from the above on whether you think this issue matters to patients or not.

 

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?

We do beat ourselves up on a regular basis in this country.  Sometimes appropriately.  But often the punches fly a little too freely.

Australia have launched a new clinical trials website today to boost patient recruitment.  It has strengths.  But it is not as good as our own UK Clinical Trials Gateway (UKCTG).  For one main reason.  While on UKCTG you can search for the trials that are open with just one click.  Australia points you to a number of sites which you then have to choose from to begin your search.  Which makes it one, two, or possibly three (Skippy) clicks away from being useful.  Seems to also want to meet the needs of all audiences whereas UKCTG is focused on the patient.  And does anyone else think it looks uncannily like ours  in terms of format and style, or is that just me?

If you want to know what’s happening with the UKCTG Patient and Public Survey, I am getting there!  I’m just in the process of re-drafting the report of the results and thinking about the recommendations.  In the meantime, UKCTG is now getting 7000+ hits a month.  Not bad with no real marketing behind it.  I’ve said enough for one day.