Following an Example… & Setting One

We are in a period of preparing for change. In the face of increased global competition, particularly from countries where clinical research was simply not conducted a decade ago, we are acknowledging at a UK and a European level that “something must be done”. In the UK, the Academy of Medical Sciences is currently considering recommendations on how the regulation and governance of UK medical research should be revised (www.acmedsci.ac.uk/p47prid80.html). Meanwhile, the European Commission has driven a number of studies and consultations into what might reinterpret, revise or replace the current patchwork of Directives and guidance built around Directive 2001/20 (http://ec.europa.eu/governance/impact/planned_ia/docs/47_sanco_clinical_trials_directive_en.pdf). Something must be done, and it will be done… eventually. But, while the wheels of political and regulatory change grind slowly onwards, what do the rest of us do for now?

Those of you who attended the ICR Annual Conference a few months ago, the ICR Patient Recruitment Forum in May, or several other meetings on the UK ‘conference circuit’ over the past few months will have heard about the North-West Exemplar project (www.ukcrn.org.uk/index/industry/nwexemplar.html), which is expected to announce its results in the next few weeks. At its simplest, the project has looked to drive the current systems for NIHR Portfolio adoption, site feasibility/selection and R&D permission as effectively as possible, through an energetic and focused team to facilitate communication, with access to the higher echelons of NHS Trusts and industry if that’s what it takes to make things happen. Although formal results have not yet been announced, interim results presented at conferences have been very encouraging.

At a pan-European level, the Clinical Trial Facilitation Group (CTFG, comprising members of the Heads of Medical Agencies, www.hma.eu/78.html) has been piloting a Voluntary Harmonisation Procedure (VHP) for the past 18 months, looking to produce more consistent outcomes for regulatory review of multination studies, while also making more efficient use of resources at national regulators. Again, while the system is not without its critics, results have generally been positive.

Both of these initiatives have improved on general current performance, with a basically ‘bottom up’ approach to working vigorously with what we have. My point is not that ‘bottom up’ approaches are innately better than ‘top down’ ones, because each of these examples have only succeeded by using the tools and structures put in place as a result of ‘top down’ thinking. However, any ‘top down’ strategy can only be as successful as its implementation, and actually implementing anything is really about work from the bottom up, and having the passion and energy to use whatever’s available to achieve the desired result.

This is the success of projects like the NW Exemplar and the CTFG VHP, demonstrating the results that can be achieved by working constructively with what we’ve already got. But this is also their failure: highlighting that potentially useful tools are often not used effectively (while perhaps weakening the argument for any more radical change). What matters most appears to be the energy, enthusiasm and commitment of the people operating the system. With the right people in all the right positions, performance could be improved far more quickly than any legislative solution could achieve. However, the degree of cultural shift required to spread these improvements widely is notoriously hard to achieve in any large organisation, particularly one with as much character as the NHS.

In the meantime, we should all look at the example being set for us by the CTFG VHP, the NW Exemplar and other initiatives, inject some more energy and passion into our work, and actively set an example for our colleagues to follow.

This could have as much impact as the legislative change we’re all calling for. And you and I can each start doing it today…

Legislative Review or Window Dressing?

One of the biggest news stories this month has been the latest announcement of an independent review of the regulation and governance of UK clinical research. This was announced by Health Secretary Andy Burnham on March 25^th, and will be conducted by the Academy of Medical Sciences, which called for such a review in its January 2010 report “Reaping the rewards: a vision for UK medical science”. In announcing the review, Mr Burnham said “It is becoming increasingly clear that medical research is getting tied up in red tape. For research to flourish and provide the huge benefit it can give to the health and wealth of the country, it needs freedom from unnecessary bureaucracy and interference.”

This sounds rather familiar, having been the rallying cry behind reviews, reports and reorganisations going back at least as far as PICTf nearly a decade ago. This was followed by the UKCRC set of initiatives (now mostly under the banner of the NIHR) and more recently the Office for Life Sciences, which published its own report on “Delivering the Blueprint” only a few months ago. All of these have overlapped, in goals and activities, and all have provided incremental solutions to specific problems. It is hardly surprising that problems still remain to be solved, but people criticising the current systems should remember the ‘bad old days’ that preceded them.

So, is the AMS review going to provide that ‘Eureka!’ moment, delivering transformative recommendations that none of the previous review panels were able to come up with? Or is it the latest window dressing on the long-running series of evolutionary reforms that have fought against the gradual ‘decline’ of UK clinical research competitiveness, as medicine development has globalised, throwing the UK’s inbuilt demographic disadvantage into sharp relief? Of course, editorial hyperbole aside, the truth of the matter will be somewhere in between. However, well-meant as it is, there are some pretty fundamental problems with this particular review…

For a start, there is the long history of reviews in this area, including the ones described above, plus internal reviews conducted by the MHRA, Department of Health etc. over the past few years (and that continue to be ‘works in progress’). Is it really plausible that the ACM panel could spot a flaw or propose a solution that had been previously missed? Indeed, the overarching issue seems to be not so much with identifying specific problems as with translating them into generalisable solutions that can be applied usefully across commercial and non-commercial research, balancing provision for public confidence with available resources, and taken up in a homogenous way by a very heterogeneous set of organisations (and combinations of organisations).

Information about the review is still pretty sparse, but it has been described as “rapid”. However, the UK is a matter of weeks away from a General Election. Even if the AMS can produce its report before the election, it will surely be buried under the media froth on other campaign issues from the economy, crime and foreign policy to the environment, UK military operations overseas and MPs expenses! With the election widely expected to result in a change of government, there is no guarantee that the incoming politicians will choose to implement any of the AMS’ recommendations, and might even decide to commission yet another review on taking office…

Finally, a similar debate has been taking place on a pan-European level, with the European Commission already being more than 12 months into a discussion on the impacts of the Clinical Trials Directive, with broad consensus that something must and will be changed, and increasing acceptance that the text of the Directive itself might be part of that change. There is surely much wrangling to be done at this level over the next few years, but when this is complete, the UK legislation will have to change all over again as a result, regardless of any improvements brought about by the AMS.

So, although its aims are laudable, there is little practical value in commissioning this review now: it duplicates reviews that are already in progress, it’s unlikely to be able to solve the multi-level problems it’s designed to address, and the broader legislative environment is likely to change soon anyway! Sometime, somehow, further reform of UK clinical research regulation and governance is certain to take place, but the timing and context of this review appear certain to undermine any value that it could add.