Contract agreement boosts medical device trials The development of innovative medical devices in the UK has received a boost: a new agreement makes it easier to get approved trials in patients underway.
Launched jointly by the Department of Health and the Association of British Healthcare Industries, the model Clinical Investigation Agreement (mCIA) has been welcomed by the medtech industry.
The mCIA covers all medical technology trials funded by industry with patients in NHS hospitals. It removes much of the bureaucracy that has been a barrier to the efficient start-up of such trials in the UK, while meeting the Government’s requirements for transparency. It is closely aligned with the revised model Clinical Trial Agreement for pharmaceutical industry-sponsored research in NHS hospitals (mCTA) that was published in 2006.
Public Health Minister Dawn Primarolo said: “The model Clinical Investigation Agreement is the fi rst 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.”
Peter Ellingworth, Chief Executive, Association of British Healthcare Industries (ABHI), commented: “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... should help with the goal of making the UK a world-class environment in which to conduct clinical research on innovative medical technologies.”
UKTI helps medtech SMEs to export UK Trade & Investment (UKTI) has announced new funding rules that will help small and medium-sized businesses to take part in overseas trade fairs such as Medica.
The number of Tradeshow Access Programme (TAP) grants that an SME can apply for in its lifetime has been increased from three to six, with the proviso that the company takes part in trade shows in more than one market.
TAP grants are aimed at SMEs that are relatively ‘new to export’, and this term is being revised to broaden the availability of support.
Gareth Thomas, Minister for Trade and Investment, said: “Small and medium-sized enterprises are the lifeblood of any economy. In difficult times, businesses need to be flexible and innovative and seek out opportunities where they exist.
“Small businesses can find it hard to break into new markets on their own, but UKTI is there to help as their springboard for global growth. These new rules give SMEs more opportunities to access foreign markets and enable them to attend follow-up trade fairs in markets where they see potential for their business.”
King’s Fund urges NHS to go online The NHS needs to adopt IT solutions more quickly, according to healthcare thinktank the King’s Fund.
A new report, Technology in the NHS, argues that the NHS is falling behind other sectors in the use of e-mail and the Internet, which offer many benefits to patients and clinicians.
The authors recommend that patients should be able to use online communications to book appointments with their GP, receive routine test results, view their medical records and undergo consultations. It also calls for innovative devices such as RFID tags to be made available.
Alasdair Liddell, co-author of the report, commented: “Many of us now use the Internet to bank, shop, and book holidays. But somehow the NHS has not embraced this technology.”
Despite Lord Darzi’s review of the NHS, the King’s Fund report argues, there are still barriers to NHS adoption of new technologies: lack of resources, lack of incentives for clinicians and lack of leadership from the DH.
The report highlights technologies that could become available to NHS patients and clinicians in the next decade, including the ‘doctor’s e-bag’ (a portable computer with diagnostic testing and decision support facilities); nutritional content scanners for food items; smart pill dispensers; and RFID tags with patient data.