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.