A model Clinical Trial Agreement (mCTA) tailored specifically to contract research organisations (CROs) has been introduced for studies conducted through the UK’s National Health Service (NHS).

The CRO mCTA is based on the revised model Clinical Trial Agreement for pharmaceutical companies and NHS organisations introduced in the UK in October 2006. As with that document, which removed the need for individual site-by-site reviews in negotiating agreements for industry-sponsored trials in NHS hospitals, the aim is to streamline procedures and enable studies involving NHS patients to start more quickly. The UK Clinical Research Collaboration (UKCRC), which is working to make the NHS a first-choice location for clinical trials in the face of increasing competition from abroad, is among the bodies that have endorsed the new agreement.

Developed jointly by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), the Clinical Contract Research Association (CCRA) and the Departments of Health for England, Wales, Scotland and Northern Ireland, the tripartite CRO mCTA is designed for use by the pharmaceutical company sponsoring the trial, the contract research organisation managing it and the NHS organisation in which the trial takes place. Like the October 2006 mCTA, it applies to Phase II-IV studies involving patients in NHS hospitals, as well as Phase I trials involving NHS patients. Both agreements specifically exclude Phase I trials with healthy volunteers.

The CRO mCTA is also specifically geared to contract clinical trials, defined as “commercial, industry-sponsored trials of investigational medicinal products, involving NHS patients, undertaken in NHS hospitals, usually directed towards pharmaceutical product licensing”. Collaborative clinical research, including investigator-led commercial trials, will continue to be addressed by contracts between the company providing resources for the trial and the holder of the investigator’s substantive employment contract, be that a university or an NHS body.

Not mandatory

Use of the CRO mCTA is not mandatory for NHS hospitals or NHS/BIA member companies. However, both these industry associations as well as the UK health departments strongly recommend routine use of either the mCTA or the CRO mCTA for contract commercial clinical trials involving NHS patients, preferably with no modifications other than those needed to identify correctly the trial, contracting parties and investigator, and to set out financial terms and arrangements for recruiting participants.

The launch of the CRO mCTA “marks another positive step to develop the NHS as a world-class environment for health research,” commented the UKCRC. “Its development also demonstrates the willingness of a broad range of organisations to collaborate on reducing the barriers to clinical research.”

The CRO mCTA and accompanying guidance notes are available for downloading from the UKCRC’s website at www.ukcrc.org.