A package of measures building on existing efforts to restore the UK as a first-choice location for clinical trials were included in the well-received Life Sciences Blueprint just published by the government’s new Office for Life Sciences (OLS).
Acknowledging that in recent years the UK has “lost ground internationally as a valued country site for undertaking clinical investigations of medical technology and later-phase clinical trials for drugs”, the Blueprint offers a number of remedies including more emphasis on clinical research in the NHS Operating Framework; putting local research management on a more professional footing; introducing risk-based approaches; and moving forward with plans to make optimal use of electronic health records for research.
In particular, the report notes, trial start-up times, recruitment, reliability and cost have “impacted significantly on the overall cost-effectiveness” of the UK as a location for clinical research. In recognition of these problems, the government will support the health service in:
– creating a national framework for professional local management of health research;
– transitioning NHS Research and Development Departments to a new role as Research Support Services Departments of the National Institute for Health Research (NIHR);
– adopting standard operating procedures and a shared risk-based approach “in order to create a step change in speed and reliability for commercial and non-commercial trials in the NHS”.
More generally, the government will reinforce the need for greater emphasis on research and clinical trials in the next NHS Operating Framework, “building on the existing commitment to include numbers of patients in clinical research in the metrics which Trusts report in their Quality Accounts”.
In its recent response 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, the government said it would work with the NHS to ensure that healthcare providers included in their Quality Accounts the number of patients recruited for clinical research during the previous year. It would also “explore other appropriate research indicators that link to the quality of care for inclusion in Quality Accounts, and/or other national reporting mechanisms”.
However, the government balked at the Cooksey report’s recommendation 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”. It insisted the objective set in the NHS operating framework for 2009/10 – to double the number of patients taking part in clinical trials and other well-designed research studies within five years – was “more realistic”.
The OLS Blueprint also says the government will underline the strategic importance of health research to the NHS by clarifying “the duty on Strategic Health Authorities to promote innovation”, highlighting their role in encouraging R&D access across healthcare organisations.
As far as electronic health records are concerned, the government commits in the Life Sciences Blueprintto furthering the momentum generated by the NHS Connecting for Health’s Research Capability Programme and its equivalents in the devolved administrations of Scotland, Wales and Northern Ireland by:
– working with the major stakeholders to implement and resource the strategic framework agreed by the Office for Strategic Coordination of Health Research’s E-Health Records Research Board; and
– ensuring a clear implementation plan is developed by the end of 2009, with business cases and joint piloting with industry.
These measures are designed to make sure that the UK “exploits its position as a world leader in health informatics”, the Blueprint says.
