New Single Research Contract Aims To Speed Up Contracting Process For Industry-sponsored Trials, UK
This new type of agreement marks another positive step to develop the NHS as a world-class environment for health research in the public interest.
Having seen the success of the model Clinical Trial Agreement in speeding up the initiation of clinical trials, notably demonstrated in a study following its introduction in Scotland, companies and Trusts have sought a similar type of model Agreement for trials managed by Contract Research Organisations.
Professor Sally Davies, Director General of Research and Development at the Department of Health said:
"This represents another important step in the development of the R&D Partnership between the NHS and the pharmaceutical industry. 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."
The new contract is a tripartite agreement between the pharmaceutical company sponsoring the trial, the contract research organisation managing it and the NHS Trust where the trial takes place. It will complement the bipartite agreement model used by pharmaceutical companies and NHS Trusts published in 2006.
The CRO mCTA is for use CRO-managed trials in NHS hospitals. This covers Phase 1-IV in NHS patients. It specifically excludes Phase 1 trials in healthy volunteers. The contract is put in place once a trail has regulatory approval from the MHRA and ethics approval. Both the mCTA and the CRO mCTA give Trusts and companies confidence, as they work together on a clinical trial, that appropriate legal safeguards are in place, without the need for negotiation between each Trust and company on a trial by trial basis, thus speeding up the process of setting up approved clinical trials, making it easier for more patients to access innovative new treatments, and saving legal fees.
The intention is to accelerate the start-up of industry-sponsored clinical trials that are managed by contract research organisations on hospital patients in the NHS. This will also mean that patients have faster access to treatments and the NHS will save money on a more streamlined system.
The CRO mCTA has been agreed by the Association of the British Pharmaceutical Industry (ABPI), the Bio Industry Association (BIA),the Clinical Contract Research Association (CCRA), the NHS and the Department of Health, demonstrating a willingness to collaborate at all levels to reduce the barriers to commercial clinical research.
1. This is the first time a CRO-managed mCTA has been launched. It follows the launch of the revised mCTA in October 2006 by the Department of Health, the ABPI and BIA as a result of recommendations made in the Pharmaceutical Industry Competitiveness Task Force Report.
2. Both model Clinical Trials Agreements are designed to avoid one of the greatest impediments to the quick and efficient initiation of trials in the UK which had already secured regulatory and ethical approval - the site-by-site review and renegotiation of Clinical Trial Agreements.
3. The Agreement, negotiated with English law and governance agreements at its core, has been appropriately modified for use under the legal systems and administrative arrangements of Wales, Northern Ireland and Scotland. It represents the consensus view of legal and medical advisers from DH, the NHS, CCRA ABPI, BIA and selected pharmaceutical and biotech companies.
4. The Agreement has been endorsed for routine use without amendment by: the Department of Health for England; the APBI; BIA; CCRA; the NHS Confederation; Monitor; the Council of Heads of Medical Schools; the UK Clinical Research Collaboration; the NHS R&D Forum; and the devolved administrations.
5. The Department of Health's budget for health research for 2006-07 is £753m. Of this, £50m is allocated for capital funding; the rest is allocated to research through a portfolio of national research programmes.
6. 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 Department of Health (DH) aims to improve the health and well-being of people in England. The Department sets overall policy on all health issues and is responsible for the provision of health services through the National Health Service. See: http://www.dh.gov.uk.
8. Since Research and Development was established in the Department of Health in 1991, research programmes and projects have contributed to expanding the evidence base for applied health research. Between 1997 and 2006, NHS R&D spent £4.8 billion on research to promote high quality evidence in support of health and health-care, policy makers, professionals and the public.
9. More information can be found on the Department of Health's website.
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