Drug industry keen on new NHS trials Britain's drug industry has welcomed Government plans to trial new drugs ahead of approval by the regulatory body as having the potential to deliver "a truly transformational change". http://www.telegraph.co.uk/finance/news ... rials.html
By Graham Ruddick
Published: 6:31PM BST 14 Jul 2009
The Office for Life Sciences (OLS), led by Lord Drayson, is proposing an "Innovation Pass", which will make it easier for companies to get their products to market, especially those for illnesses that affect only a small number of people.
The three-year scheme will be piloted from 2010/2011 with a budget of £25m. It will see innovative drugs that have gone through the initial three phases of trial be used by the NHS before approval by the National Institute for Clinical Excellence (Nice), which decides what medicines the health service should purchase and for how much.
The proposals are part of a "Life Sciences Blueprint" designed to boost pharmaceutical groups and biotechnology companies. The scheme also includes a commitment to consider a "patent box" incentive, a lower rate of tax on profits derived from products with patents located in the UK.
Andrew Witty, the chief executive of GlaxoSmithKline, said: "Delivery of the 'patent box', the evolution of Nice and the NHS as catalysts for innovation, and the development of world-class life science clusters will be critical to the Blueprint's success."
Richard Barker, director-general of the Association of British Pharmaceutical Industry, said: "The OLS blueprint charts a course of action which is both sound and welcome. When the ship is steered safely home, it will deliver a transformational change for the life sciences industry in the UK."
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<span class="headline">Clinical trials get help in OLS Blueprint</span>
<span class="body">http://www.pharmatimes.com/ClinicalNews ... x?id=16231</span>
<span class="body">15 July 2009</span>
<span class="body">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 governments 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 reports 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 Healths 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 Researchs 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</span>
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