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  building our reputation as a leading nation for clinical research in partnership with and for industry
 

Working with Industry

The government is determined to make the UK the best place in the world for health research, development and innovation. We and our partners in health research are working to turn this ambition into a reality.

The Department of Health has already developed joint working in research and innovation with industry through the
Pharmaceutical Industry Competitiveness Task Force (PICTF), the Bioscience Innovation and Growth Team (BIGT), and the Healthcare Industries Task Force (HITF). Strategic dialogue with industry, aimed at sustaining and growing the important contribution industry makes to the healthcare received by patients in the NHS, is conducted via the Ministerial Industry Strategy Group (MISG) and the Ministerial Medical Technology Strategy Group.

We believe the National Health Service has a leading role to play in contributing to Britain's international competitiveness in health research. The National Institute for Health Research is aiming to:
  • develop the reputation of the NHS as a world-class environment for collaborative research in the public interest and
  • establish NHS as the preferred host for multi-centre clinical research in partnership with and for industry.

The NIHR is working with partners to create the best possible research environment in the NHS and build an international reputation for excellence in translational and applied research. Industry - devices, diagnostics, biotech and pharma (and associated Contract Research Organisations) - is involved at a strategic and operational level in initiatives to enhance the UK's clinical research environment. The NIHR is represented on the Board of the Office for Strategic Co-ordination of Health Research and the UK Clinical Research Collaboration. Industry-pecific issues are considered in the UKCRC Industry Reference Group, Industry Road Map Group, NIHR Medical Devices Clinical Research Working Group and the MISG Clinical Research Working Group.

The NIHR has a dedicated industry liaison team which works with industry, trade associations, other Government Departments and organisations active in supporting industry research in the NHS, e.g. the
National Innovation Centre, Health Technology Knowledge Transfer Network, NHS Innovation Hubs, Medilinks to ensure that industry needs concerning clinical research are considered in the development of new infrastructure, processes and practices.  


NIHR Office for Clinical Research Infrastructure
The NIHR Office for Clinical Research Infrastructure has been established with the aim of facilitating collaborations between the various components of the research infrastructure we fund and other research funders. A particular focus for this is with the biotechnology, healthcare and pharmaceutical industries and our aim is to deliver more rapid, informed and productive interactions for investigators who are interested in working with our research infrastructure.


Improving the environment for industry research
Speeding up trial initiation and improving recruitment reliability will be essential to the UK's status as a cost-effective environment for industry research. Initiatives implemented to achieve these objectives include:

- The
National Research Ethics Services (NRES), now part of the new Health Research Authority, which provides a single UK-wide ethical opinion and national panel of Research Ethics Committees assigned to review devices studies.
NRES 

- Roll out of the Integrated Research Application System (IRAS), supported by the UKCRC partners, including the NIHR, which enables researchers to prepare and submit applications for regulatory, ethics and governance approvals using the same integrated on-line system.
IRAS

- A series of model Agreements, drawn up by the UK Health Departments, the NIHR, the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), and the Association for British Healthcare Industries (ABHI), and approved for use in unmodified format by representatives of the NHS and universities. These nationally-approved standard agreements help speed up the contracting process for clinical trials and clinical investigations of medical devices carried out in the NHS.
model Agreements


PCT permission form for industry trials

The DH guidance, NHS permission for R&D involving NHS patients, clarified that NHS organisations can be satisfied with reasonable assurances that others will do what is required of them.

For research under the Clinical Trials Regulations, the NHS decision to give permission should normally be a formality. This is subject to sponsors confirming who is authorised to act on their behalf and providing evidence:

  • that the project has received the favourable opinion of a research ethics committee
  • the Medicines and Healthcare products Regulatory Agency (MHRA) has given authorisation
  • an appropriate process of independent expert review is followed
  • details of provisions to cover any liabilities.
The PICTF clinical research working group, in association with the NHS R&D Forum primary care working group, has developed a standard form to make explicit what is expected of industry sponsors and companies under the DH guidance. The Form allows them to make a declaration about their undertakings in a format that satisfies PCTs' need for assurances. The form is endorsed by DH, the ABPI, the BIA and the UKCRN.
 Standard PCT permission form for industry sponsored clinical trials


NIHR Clinical Research Network
The NIHR Clinical Research Network provides a single point of contact for industry studies, offers centralised and co-ordinated study feasibility assessment and support with patient recruitment.

Roll out of the
NIHR Coordinated Systems for gaining NHS Permissions (CSP), which provides a streamlined process to reduce NHS R&D approval times in studies run via the NIHR Clinical Research Network.

Introduction of a standard costing template and guideline tariff
for routine use in studies conducted via the NIHR Clinical Research Network.

Meeting industry needs
In addition to improving the processes which support initiation of research in the NHS, the NIHR is funding or supporting infrastructure and programmes which will support, via the evolving methodologies, the development of interventions for the prevention, diagnosis and treatment of ill health and the evaluation of their safety, effectiveness or performance.

Examples of how NIHR is helping to meet industry needs are shown below: 

Industry Need

NIHR Support

Better target identification and validation MRC/NIHR Translational Medicine Board initiatives e.g. MRC Developmental Pathway Funding Scheme

Biomedical Research Centres
Much earlier evidence of efficacy or otherwise (fail early, fail fast, fail cheap) MRC/NIHR Patient Research Cohort Initiative
High quality clinical research facilities
Experimental Medicine Resources 
Effective mechanism for liaison with NHS, academia and patients to develop new devices on the basis of unmet clinical need

Pilot Healthcare Technology Co-operatives: 
Devices for Dignity
enteric

Academic collaborative applied research on future med tech product development. Invention for Innovation Programme
Fast, reliable, cost effective clinical trials and clinical investigations Clinical Research Network

More effective trial modelling, feasibility and patient identification.

Clinical Practice Research Datalink 
Better pharmacovigilance, device adverse event monitoring and outcomes research

Clinical Practice Research Datalink