The UK government is sticking with its objective of doubling the number of clinical trials undertaken in the National Health Service (NHS) within the next five years, despite a recommendation that the goal should be achieved much sooner.

The government was responding to Review and Refresh of Bioscience 2015, the progress report issued in January by the Bioscience Innovation and Growth team headed by Sir David Cooksey. One of the recommendations in that report was that the NHS Operating Framework should include “a specific objective of doubling the number of patients recruited to clinical trials in NHS Trusts over the next three years”.

In its response, the government noted that the objective set in the NHS operating framework for 2009/10, which was published last December, was to double the number of patients taking part in clinical trials and other well-designed research studies within five years. “We believe that the five-year time-frame to deliver this is more realistic than three years,” it stated.

True to form, the government managed to suggest in a press release on its response to the Review and Refresh report that the five-year objective was a new initiative, as Business Secretary Peter Mandelson “announced a range of actions on bioscience aimed at ensuring Britain remains a world leader in the sector”.

The government did respond positively – although not comprehensively – to some of the other recommendations in the Cooksey report on research participation in the NHS, particularly around performance measures for clinical research.

For example, the Bioscience Innovation and Growth team had recommended that:

- The performance of NHS Trusts in conducting clinical research should be one of the quality measures against which Trusts are assessed
- Trusts should demonstrate their commitment to research by publishing goals for the number of patients involved in clinical studies on a half yearly basis and report in their quality accounts
- Every NHS Trust participating in clinical research should record and publish the average time it takes for the local approval process to be completed

Addressing these issues, the government said quality accounts “offer a transparent way to ensure that Trusts report to their local populations on research activities, which are a key element of the quality of care”.

“We will work with the NHS to ensure that providers who conduct research include in Quality Accounts the number of patients recruited in the previous year to clinical research (i.e., research which has received Research Ethics Committee approval),” the government added. “We will also explore other appropriate research indicators that link to the quality of care for inclusion in Quality Accounts, and/or other national reporting mechanisms.”

Goals for research

However, it balked at the suggestion that every NHS Trust should have a Board member designated to take responsibility for the efficient running of clinical research by the Trust.

The Department of Health (DH) Research Governance Framework for Health and Social Care (RGF), issued in 2005, requires providers of care “to be aware of all research being undertaken within their organisation and ensure that it meets the standards set out in the RGF”, the government pointed out. Accountability for this requirement lies with the Trust’s chief executive, who may delegate responsibility to a qualified and senior member of staff.

“Rather than asking each Trust to designate a Board member to take responsibility for research, the DH believes that it would be more effective for Trusts to set goals for research within their organisation and report on their achievement at least annually to the Board and in their annual report,” the government said. “The Department will be writing to the service shortly about this.”

That letter will also ask Trusts to publish the average time it takes for the local research approval process to be completed.

The government agreed with the Cooksey team that it should take a leadership role within Europe in ensuring that proposed revisions to the Clinical Trials Directive (2001/20/EC) “reinforce the UK’s attractiveness as a prime location for clinical trials”.

The Medicines and Healthcare Products Regulatory Agency (MHRA) “continues to lead discussions in the EU committees dedicated to improving the implementation of the Clinical Trials Directive, working with colleagues in the other Member States to improve harmonisation of assessment”, it noted.

The MHRA also “continues to try to assess clinical trial applications well within the prescribed timelines to meet the Government’s overall objective of ensuring the UK remains an attractive location for research and clinical trials”, the government added.