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New contract agreement for medical technology trials

DEPARTMENT OF HEALTH News Release issued by COI News Distribution Service. 6 November 2008

The development of important medical devices like hip and knee replacements, pacemakers and stents get a boost today, as a new agreement makes it easier to get approved trials in patients underway.

Launched jointly by the Department of Health and Association of the British Healthcare Industries, the model Clinical Investigation Agreement (mCIA) has been welcomed by the medical technology industry as timely and helpful.

The mCIA covers all medical technology trials in patients in NHS hospitals which are funded by industry. It removes much of the previous bureaucracy which was a significant barrier to the efficient start-up of such trials in the UK. Previously it was necessary for site-by-site reviews and local legal agreements to be drawn up before industry-sponsored trials could begin. The mCIA meets the Government's requirements for transparency about research involving NHS patients and ensures that all medical technology industry-sponsored clinical trials are registered and published. Experience with its use will be reviewed after one year.

Public Health Minister Dawn Primarolo said:

"The model Clinical Investigation Agreement is the first time that all UK Health Departments, the NHS and representatives from industry have agreed standard contract requirements for medical technology industry-funded clinical trials. This has been developed to enhance the UK clinical research environment for the benefit of NHS patients."

This Agreement is one of a range of initiatives that have already been introduced to improve the clinical research environment. The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new services that speed-up the assessment of Clinical Investigations for regulatory purposes and an industry-focused advice service. The National Research Ethics Service (NRES) has introduced a speedy and streamlined process using device-flagged committees which have expertise in device studies, as well as guidance on the ethical review of device studies. In addition, the Integrated Research Application System (IRAS) provides an electronic portal for the single submission of data required for the regulatory research permissions and approvals needed to initiate a clinical research study.

Industry Co-Chair of the Ministerial Medical Technology Strategy Group, John Jeans said:

"The Ministerial Medical Technology Strategy Group fully supports the principle of the model Clinical Investigation Agreement for medical device companies carrying out clinical investigations in collaboration with the NHS. This document should serve as another step towards enhancing the UK environment for medical device research and development. "

Sally Davies, Director General of Research and Development, Department of Health said:

"Supporting research for, and in collaboration with, medical device industries is at the heart of the NHS's research agenda and the National Institute for Health Research's bureaucracy-busting agenda. This Agreement is one of a number of wide-ranging process improvements for clinical trials being introduced by the National Institute for Health Research Clinical Research Network."

Peter Ellingworth, Chief Executive, Association of the British Healthcare Industries (ABHI) said:

"ABHI welcomes the launch of the model Clinical Investigation Agreement which has been the result of a great deal of work by the Department of Health, the medical devices industry and NHS stakeholders. The new Agreement for both regulatory and post market medical device studies will fulfil the need for a document that has the confidence of all parties in order to streamline the administrative process of getting approval for clinical investigations underway at NHS sites. It should also help with the goal of making the UK a world-class environment in which to conduct clinical research on innovative medical technologies."

Notes to editors

1. The mCIA is for use in industry funded clinical research in patients in NHS hospitals. The contract is put in place once the trial has received a Letter of No Objection from the Medicines and Healthcare products Regulatory Agency (MHRA), where applicable, and ethics committee approval.

2. You can download more information about the mCIA at:
http://www.ukcrc.org/activities/regulationandgovernance/modelagreements/mcia.aspx

3. This agreement is closely aligned with the revised model Clinical Trial Agreement for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals (mCTA) that was published in 2006, and the Tripartite clinical trial agreement for pharmaceutical and biopharmaceutical industry sponsored research in NHS hospitals, managed by Contract Research organisations (CRO-mCTA) published in 2007.

Link to revised mCTA:
http://www.ukcrc.org/activities/regulationandgovernance/modelagreements/modelclinicaltrialagreement.aspx

Link to CRO-mCTA:
http://www.ukcrc.org/activities/regulationandgovernance/modelagreements/cromcta.aspx

4. The mCIA is the agreed position of legal and medical advisers from DH, the NHS, ABHI and selected medical device companies. It has been endorsed for routine use without amendment by: the UK Health Departments; the ABHI; the Ministerial medical Technology Strategy Group; the NHS Confederation; the Medical Schools Council; the UK Clinical Research Collaboration; the NHS R&D Forum; and the Institute for Clinical Research.

5. Link to the UKCRC site with the Board statement of support, the guidance notes and all the national agreements: http://www.ukcrc.org/activities/regulationandgovernance/modelagreements.aspx

6. The Department of Health
The Department of Health's budget for health research for 2008-09 is £875m. Of this, £50m is allocated for capital funding; the rest is allocated to research through a portfolio of national research programmes. The funding supports clinical research in the NHS, research commissioned for policy development, and the NHS costs incurred in supporting research funded by other bodies such as the Research Councils and charities. Some funding is provided to increase capacity to undertake research, and to underpin the UK Clinical Research Collaboration and priority disease research networks.

7. The Government's health research strategy Best Research for Best Health was published in January 2006. The strategy and its implementation plans are available at: http://www.nihr.ac.uk/search.aspx?Criteria=best+research+for+best+health&Page=1

8. ABHI
The Association of British Healthcare Industries is the lead trade association for the UK medical systems and devices industry (manufacturers of medical devices, equipment and consumables and other suppliers to the medical community). It has around 200 corporate members whose output is about 80% of the industry total of about £8bn. The industry is a net exporter and approximately 46,000 people are employed directly or indirectly in the UK. ABHI's membership includes several Special Interest Sections and four sectoral trade associations which in turn have a further 400 members. For further details contact 020 7960 4360 or visit http://www.abhi.org.uk

9. MHRA
MHRA is the government agency responsible for ensuring that medical devices and medicines perform as claimed and are acceptably safe. Underpinning the work of the agency lie robust and fact based judgements to ensure that the benefits to patients and the public justify the risks.

MHRA is the competent authority (regulatory body) within the UK responsible for the implementation of the medical devices regulations. One if its functions is to undertake rigorous assessment of proposed clinical investigations of pre-market devices to ensure that such devices have undergone appropriate pre-market testing and are safe to be tested in human subjects. Trials may not proceed unless the competent authority is satisfied as to the safety of the device. For further information visit http://www.mhra.org.uk

10. MHRA, the National Research Ethics Service (NRES), ICR and the NHS Forum have jointly produced guidance for researchers, manufacturers, research ethics committees and R&D offices on arrangements for regulation and ethical review of medical devices clinical research medical devices
Link to http://www.nres.npsa.nhs.uk/rec-community/guidance/

For further information, please contact the Department of Health press office on 020 7210 5221.