| 11 November 2008 |
THE testing of vital medical devices like hip and knee replacements, pacemakers and stents received a boost this week as a new agreement was announced which will make it easier to get approved NHS patient trials underway.
Launched jointly by the Department of Health and the Association of the British Healthcare Industries, the model Clinical Investigation Agreement (mCIA) has been welcomed by the medical technology industry as timely and helpful in the current financial climate.
The mCIA covers all industry-funded medical technology trials in patients in NHS hospitals and removes much of the bureaucracy which is seen as a significant barrier to their efficient launch in the UK. Previously it was necessary for site-by-site reviews and local legal agreements to be drawn up before testing could begin.
Public health minister, Dawn Primarolo, explained: “The mCIA is the first time all UK health departments, the NHS and representatives from industry have agreed standard contract requirements for medical technology industry-funded trials and has been developed to enhance the UK clinical research environment for the benefit of NHS patients.”
The agreement is just one of a raft of measures introduced to improve the UK’s clinical research environment. The Medicines and Healthcare products Regulatory Agency has already launched new services to speed up the assessment of clinical investigations for regulatory purposes and has launched an industry-focused advice service. In addition, the National Research Ethics Service has streamlined the process with committees of expertise on the ethical review of device studies and the Integrated Research Application System provides an electronic portal for the single submission of data required to initiate research.
John Jeans, industry co-chairman of the Ministerial Medical Technology Strategy Group, said: “We fully support the principle of the model 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.
The announcement has also been welcomed by the Association of British Healthcare Industries (ABHI). Its chief executive, Peter Ellingworth, told HES: “This agreement has been the result of a great deal of work by the Department of Health, the 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.”
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