A model Clinical Investigation Agreement (mCIA) introduced in the UK should make it easier to get clinical trials for medical devices off the ground.

The new agreement launched jointly by the Department of Health (DoH) and the Association of British Healthcare Industries (ABHI) is closely aligned with the revised model Clinical Trial Agreement (mCTA) published in 2006 for studies in National Health Service hospitals sponsored by (bio)pharmaceutical companies, as well as the related agreement for research managed by contract research organisations (CRO-mCTA) that was introduced last year.

Like those agreements, the mCIA is designed to remove layers of bureaucracy that have been a barrier to trial start-ups in the NHS. Previously, the DoH noted, industry-sponsored trials of medical technologies such as hip and knee replacements, pacemakers and stents were subject to site-by-site reviews and local legal agreements. The mCIA also meets the government’s requirements for transparency in NHS research and ensures that all industry-led trials of medical devices are registered and published, the Department said.

Experience with the model agreement will be reviewed after one year. The mCIA is one of a range of initiatives undertaken to improve the clinical research environment for medical technology in the UK, the DoH pointed out. The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new services to speed up the regulatory assessment of clinical investigations as well as an industry-focused advice service.

The National Research Ethics Service (NRES) now offers a streamlined service using committees with specific expertise in device studies. It has also introduced guidance on the ethical review of clinical trials with medical technologies.

ABHI chief executive Peter Ellingworth said the mCIA would “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”.

The new contract is put in place once a medical device study has received a Letter of No Objection from the MHRA (where applicable) and ethics committee approval.