DoH introduces CRO mCTA

The Department of Health (DoH) has announced the introduction of the Contract Research Organisation model Clinical Trial Agreement (CRO mCTA), a single research contract with the goal of speeding up the contracting process for trials sponsored by the industry.

It notes that the CRO mCTA replaces the existing system where individual hospital trusts negotiate with a number of different contract companies.

The contract sets up a tripartite agreement between the NHS trust where a trial takes place, the contract research organisation managing the study and the pharmaceutical company sponsoring the trial and seeks to complement the bipartite model used by NHS trusts and pharmaceutical firms published last year.

Professor Sally Davies, director general of research and development at the DoH, said: “The use of this agreement by research managers in the NHS will help to implement the ‘bureaucracy busting’ agenda of the National Institute for Health Research and increase opportunities for NHS patients to participate in clinical trials of new medicines across the whole spectrum of human diseases.”

She added that this agreement marks progress in the development of a research and development alliance between the pharmaceutical industry and the health service.

In April 2007, the DoH announced an agreement designed to enable faster initiation of clinical trials conducted within NHS primary care and sponsored by pharmaceutical firms, with industry representatives filling out a standard form when applying for permission to begin trials in GP practices.