Fall in clinical trials of drugs through NICE

Investment by drugs companies and access by patients to innovative medicines in the UK are coming under threat, as data show a decline in the number of clinical trials conducted in this country.

Bureaucracy, low recruitment rates and the slow uptake of new drugs are pushing pharmaceutical companies to undertake more research in other countries in Europe and North America, as well as increasingly in low cost developing nations.

In spite of efforts by the labour government to make trials cheaper, faster and easier to conduct, the UK’s disproportionately strong historic role in the development of medicines is being undermined. 

Data show a declining role for the UK since the turn of the decade, with its share of global clinical trials falling from 6 per cent in 2002 to only 2 per cent in 2007.

The latest figures from the Department of Health show the number of mid-stage, late-stage and post-approval clinical trials fell from 728 in 2008 to 470 this year, its lowest level in the past decade. Early-stage trials fell to 210, the lowest in five years.

The data were corroborated by figures provided to the Financial Times by Quintiles, one of the world’s leading clinical research organisations, which conducts trials for most significant drug companies. These show that the number of patients recruited into mid and late-stage clinical trials in the UK stagnated at 782 last year compared with 749 in 1999. 

By contrast, patient numbers during the same 10-year period almost doubled to 1,283 in France; trebled to 31,617 in the US and to 3,657 in Poland; and quadrupled to 2,117 in the Czech Republic.

Dennis Gillings, chief executive of Quintiles, which has continued to expand early-stage clinical trials in the UK, said: “We would be happy to invest more in the UK, but there’s a feeling that the NHS has a negative attitude towards industry and a reluctance to pay for drugs.”

The statistics come in spite of rising patient recruitment in some areas, including cancer trials, and a broader range of efforts in conjunction with industry to streamline approvals, reduce costs and encourage National Health Service doctors to participate in research.

The findings come as researchers lead calls for reforms to the EU’s clinical trials directive. A consultation on revising the legislation closes in early January. But Kent Woods, head of the Medicines and Healthcare Products Regulatory Agency, the UK body that scrutinises new drugs, said only minor modifications were required to distinguish standards for high-risk and low-risk trials.

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