Clinical Trials

A Happy New Year to you all.

Given that we are all likely to have to suffer several months of phoney elections wars not to mention the odd leadership coup that isn’t I thought it would be refreshing to start the year off with a hard, solid fact.

In 2008-2009, AMRC’s member charities funded 166 clinical trials in the UK to the cost of £69 million.  I mention that because today AMRC publishes its response to the European Commission public consultation paper on how well the EU Clinical Trials Directive has worked in practice since it came into law in 2001.

Clinical trials are research studies that involve patients or healthy people and are designed to test new treatments.  In recent years charities have shown increasing interest in funding trials as part of their overall research strategy (for more on what trials are and what they are not, have a look at this excellent leaflet and booklet published by UKCRC). 

UK charities are perhaps unique across Europe in both raising public donations to fund such work and in fulfilling the more traditional patient group role in terms of information and advocacy.  From events I have been involved which have involved Non-Governmental Organisations (NGOs) from other EU countries, funding trials is just not on their radar screen.

So we should be proud of the role that charities play in funding trials in this country.  And we should recognise that the sector has a very important part to play in shaping a revised Clinical Trials Directive in the common interests of patients and science.

Briefly, the current Directive is a good example – of which there seem to be all too many these days – of legislation passed with the right intentions but with little heed paid to the practicalities.  Few if any would argue with the Directive’s aims of promoting patient safety and achieving greater harmonisation and simplification across Member States.  But the result is law which has, at the very least, represented a significant challenge in terms of implementation.  At its worst we have seen an increase in regulation and bureaucracy, associated negative impacts in terms of costs and time-delays.  All of which are counter-productive to the ultimate aim of enabling clinical trials to be set up and conducted, safely and at the same time efficiently

In this month’s issue of The Times” ‘Eureka’ magazine, Mark Henderson has written an interesting piece about what one might call the ‘science deficit’ in the EU which lies at the root of  such law reaching the statute book.  I agree with his observations.  But we should not also gloss over the fact that the UK failed to engage early and activly in the process of crafting the Directive last time around.  It would be irresponsible of us to make the same mistake again in making this a better piece of legislation in the interests of patients.

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