January 11, 2011 / 12:05 AM / 9 years ago

Government seeks to simplify, speed up clinical research

LONDON (Reuters) - The government said on Tuesday it would seek to implement plans to simplify the country’s system for regulating health research to reduce red tape and make health innovations available to patients more swiftly.

In a report welcomed by pharmaceutical industry groups, the Academy of Medical Sciences (AMS) proposed the creation of a new Health Research Agency, which it said would act as a single portal for all the approvals needed for clinical research.

“The regulatory and governance environments for doing health research in the UK have been utterly stifling. Over the last 10 years there have been more and more regulatory and governance measures put in place ... and the cumulative effect has been devastating,” said Michael Rawlins, chair of the AMS working group that drew up the plan. “We cannot go on like this.”

The report and proposal for a single UK research agency was supported by industry groups and health charities, and Health Minister Andrew Lansley responded immediately by saying the government would “consider carefully how to implement” it.

“The ... report makes the case for simplification under a health research agency that will streamline and co-ordinate regulatory and governance processes,” he said in a statement.

The planned Health Research Agency would incorporate the current National Research Ethics Service as well as six other ethics review bodies and provide a “one stop shop” for advice and approvals on ethics.

It would also include a new national governance service responsible for nationwide permissions for trials and studies within the National Health Service (NHS), cutting out the need for researchers to get approval from each local NHS authority separately.

Rawlins said a fertile health research environment was vital for Britain’s health and wealth, but the current burdensome system for having research approved was denying patients early access to new medicines and hampering public health gains.

According to the report, Britain has created nearly a quarter of the world’s top 100 medicines and its share of academic citations in clinical and health sciences is currently second only to the United States. But recent data show a decline in Britain’s share of global clinical research activity.

The AMS working group was set up by Prime Minister Gordon Brown, who expressed concern at an alarming drop in the proportion of British patients being recruited into clinical trials, from 6 percent of the global total in 2000 to around 2 percent in 2006.

Britain is also losing out to other countries in the European Union (EU), notably Germany and Spain, the report’s authors said. By 2007, the proportion of products in clinical trials in the EU that were being developed in Britain was just 24 percent, down from 46 percent in 2002.

The Association of the British Pharmaceutical Industry (ABPI) welcomed the plans and called on ministers to act quickly to put them into practice: “The timely endorsement and implementation of this report ... is vital if the UK is to be seen as a serious player in clinical research in an increasingly competitive arena,” a spokeswoman said in statement.

Editing by Ben Hirschler and Jon Loades-Carter

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