Stakeholders

C F H I P R S T

C

• Clinical champions

  Clinical champions are members of the clinical community who will help lobby for the use of the innovation and promote it to colleagues.

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• Commissioners

  Healthcare commissioners are responsible for assessing and approving the use of the innovation within the local healthcare sector.

  • In England, this will predominately be the Integrated Care Board (ICB; includes former clinical commissioning groups (CCGs)) within the local Integrated Care System (ICS). Beyond the local sector, the commissioner would be NHS England .
  • In Wales, commissioning falls within the remit of the local health boards (7 covering all of Wales).
  • In Northern Ireland commissioning falls within the remit of the Health and Social care board in which local commissioning groups, which cover the 5 Health and social care trust geographical areas, focus on the planning and resourcing of services.
  • In Scotland, commissioning falls within the remit of the Community Health Partnerships (CHPs) which are overseen by the territorial NHS Scotland boards.

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F

• Funders

  In this context, funding bodies refers to organisations or entities that provide funding to universities/companies to support scientific discoveries, conduct research, and develop and progress healthcare innovations towards patient benefit.

  Potential funding bodies in the UK:

  • UKRI (UK Research and Innovation), also including Innovate UK and Knowledge Transfer Partnerships
  • Charities (e.g. CRUK, BHF, Wellcome, LifeArc)
  • National Institute for Health and Care Research (NIHR)
  • Commercial/investor (e.g. venture capital firms)

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H

• HC professional

  A healthcare professional is a clinician or Allied Health Professional (AHP) working with the patient group(s) the innovation is meant to benefit. These healthcare professionals may be the end users of the innovation, may prescribe the innovation to patients, or may monitor patients using the innovation.

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• Health economists

  A health economist analyses resource allocation in healthcare, evaluates policies and interventions for efficiency, and contributes insights to improve decision-making in healthcare organisations. With a focus on enhancing overall performance and equity in healthcare delivery, they incorporate metrics like Quality-Adjusted Life Years (QALYs) for a comprehensive assessment.

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• Health technology assessment bodies

  These organisations are responsible for evaluating the clinical and cost-effectiveness of healthcare technologies, including medicines and treatments, and providing guidance or recommendations for their use within their respective regions or countries.

  • In England, the National Institute for Health and Care Excellence (NICE) is responsible for assessing the majority of health technologies to provide guidance for commissioners and practitioners on whether an innovation is of benefit to patients or the NHS.
  • In Wales, health technology assessment and guidance are managed by the All Wales Medicines Strategy Group (AWMSG) and the Health and Social Care Committee.
  • In Scotland, the responsible bodies for assessment and guidance are the Scottish Health Technologies Group (SHTG) for health technology and the Scottish Medicines Consortium (SMC) for medicine. The Scottish Intercollegiate Guidelines Network (SIGN) is responsible for developing evidence-based clinical practice guidelines.
  • In Northern Ireland, the Department of Health (DoH) reviews guidelines produced by NICE and decides whether they are relevant to Northern Ireland. Some technologies will be assessed by specialised initiatives such as the UK National Screening Programme or Genomics England.

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I

• Industry

  Industry partners can include manufacturers of device components, test houses for assessment of compliance with ISO standards and regulations, companies to which the innovation is licenced, distributors of the device, or a spin-out company that is taking over the commercialisation activities.

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P

• Patients

  This includes individual patients as well as patient organisations, charities, faith & community organisations. Patients are meant to benefit from the innovation and may be the end users of it.

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• Potential end users

  End users are individuals who will directly use the innovation. This could include public partners or healthcare professionals.

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• Public partners

  This includes patients and potential patients, people with lived experience, service users, carers, communities and members of the public work that could be impacted by the innovation, independently on whether the particular individual will benefit from the innovation. For more details, see https://phirst.nihr.ac.uk/public-partnership/.

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R

• Regulatory advisors

  This includes regulatory bodies who provide approvals for medical devices, and professionals who provide guidance and assistance to individuals, businesses, or organisations in navigating and complying with regulatory requirements for medical devices.

  • Medicines and Healthcare products Regulatory Agency (MHRA): MHRA is an executive agency, sponsored by the Department of Health and Social Care, regulating medicines, medical devices and blood components for transfusion in the UK. MHRA will need to be notified and provide approval for any clinical investigation involving novel medical devices.
  • British Standards Institution (BSI): BSI is the UK national standards body producing technical standards on a wide range of products and services as well as supplying certification and standards-related services to businesses.
  • Consultant regulatory experts: Independent consultancy bodies and organisations that can be contacted to advise on regulatory matters such as advice in compiling technical file for clinical investigations approval by the MHRA or for obtaining UK/CE marking.

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• Research Innovation System

  • In England, the NHS Accelerated Access Collaborative brings together industry, government, regulators, funders, patients and NHS to help deliver the best health innovations to patients faster. It is a partnership of numerous groups working together to promote the adoption of new innovations into healthcare and includes:
    • Academic Health Innovation Networks (HIN; formerly called Academic Health Science Networks (AHSNs)) – There are 15 HINs across England who work with healthcare organisations, universities and businesses to spread innovations within the NHS. It also includes regulators such as the Medicines & Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) and more information on these can be found below.
    • Academic Health Science Centres (AHSCs) – AHSCs are regional partnerships bringing together expertise from universities and NHS organisations. Working with local partners including local authorities and industry, they improve health and care services by translating early scientific research and discoveries into benefits for individual patients and local and national populations.
    • NIHR Applied Research Collaborations (ARCs) – ARCs join up some of the country’s best universities, leading innovators and local authorities to solve some of the biggest issues facing health and social care over the next five years. The funding has been awarded to 15 partnerships covering every area of England, made up of health and care providers, commissioners, local authorities, universities, private companies, charities, and academics, who will work together to address specific health or care issues in their region.
    • Biomedical Research Centres (BRC) - NIHR’s Biomedical Research Centres (BRCs) are collaborations between world-leading universities and NHS organisations that bring together academics and clinicians to translate lab-based scientific breakthroughs into potential new treatments, diagnostics and medical technologies.
    • NHS Trusts Research & Innovation – These are Research and Innovation departments responsible for research delivery within NHS trusts.
    • NIHR Clinical Research Network (CRN) – CRN supports patients, the public and health and care organisations across England to participate in high-quality research, thereby advancing knowledge and improving care. The CRN is comprised of 15 Local Clinical Research Networks and 30 Specialities who coordinate and support the delivery of high-quality research both by geography and therapy area. National leadership and coordination is provided through the CRN Coordinating Centre.
  • In Wales, research and innovation activity is managed through Health and Care Research Wales including CRNs.
  • In Scotland, this comes under the remit of NHS Research Scotland.
  • In Northern Ireland, health and social care services are combined under the Health and Social care (HSC) Northern Ireland umbrella (unlike the rest of the UK where health care is in the remit of each nation’s NHS and social care is is provided by at the local council level). The Health Innovation Research Alliance Northern Ireland is the ecosystem which brings together industry, academics and health organisations to drive innovation. In addition, HSC Northern Ireland provides core funding for the Northern Ireland Clinical Research Network (NICRN).

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S

• Study sponsor

  The study sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study / clinical investigation. However, the study sponsor is not necessarily the funder.

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T

• Technology Transfer Office

  A Technology Transfer Office aims to facilitate the commercialisation of the research that takes place within a university. This includes IP management (e.g. patents, trademarks), technology assessment and licensing. Work is conducted in collaboration with a range of stakeholders including IP attorneys, market access specialists and investors.

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