It has come to this.  The world’s top tennis players rush their shots to beat an 11pm curfew.  Bruce and Sir Paul are turned-off mid-performance.  And they don’t use real javelins in schools.

Looking across the the athletics field at my sons’ school sports day, I spied a clutch of children competing in the javelin.  Except this is not a javelin as I remember it.  It’s more like one of those foam beach toys.  But nowehere near as good.  In fact it’s probably more like throwing a giant, over-ripe banana.  I admire the optimism of a small boy as he lets fly.  I imagine his disappointment as it is carried sideways by the wind and belly-flops to the ground.  There is no point to the javelin I mused.

UK scientists who have long complained about the blunt and risk-averse nature of the current EU Clinical Trials Directive, will no doubt be pleased by the Commission’s announcement today to bring in a sharper legislative instrument.  The new ‘Regulation’ will mean lighter touch regulation for ‘low-risk’ clinical trials and a streamlining of the regulatory process across the EU.  This, married with the EU’s recent enthusiasm for making trial data publicly available, also looks like good news from a patient perspective. Nature coverage here.

Whether it stacks-up against the five ‘wishes’ that the European Patients Forum (EPF) expressed during the consultation about the existing Directive remains to be seen.  The Forum hoped that any revision of EU law would result in:

1. Ensuring meaningful patients’ involvement across all aspects of clinical trials;

2. Giving patients access to quality information regarding clinical trials;

3. Meaningful informed consent;

4. Transparency concerning the results of clinical trials;

5. Access to treatments after the end of clinical trials.

Faster, quicker, leaner trials, yes.  Rules that reflect patient choice, voice and experience, I fear not.

The Commission’s own web pages have a stack of information available about the new Regulation including a ‘Citizen Summary.’ That all other documents constantly refer to research ‘subjects’ betrays the fact that the full extent of the patient agenda is not quite part of their core philosophy.  Indeed. the summary is just that, it doesn’t really convince in explaining how citizen rights and interests have been reflected in the proposals.

When is science, or more particularly medical research, going to wake-up to the fact that the effectiveness of modern regulation and modern regulators hinges on a partnership between those being regulated and their consumers?  Perhaps closer to home we might have greater cause for optimism.  The new Health Research Authority (HRA) has just had its second public involvement workshop and is working through the options of what might be tangible outcomes of this work as part of its business plan.

Back in Brussels, I hate to say it, but it still feels like we are being given foam arrows.  And with none of the fun of the beach.

Enjoy your summer holidays.