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Model clinical trials agreements

  • Last modified date:
    23 October 2009

Nationally approved standard agreements help speed up the contracting process for clinical trials carried out in the NHS. The agreements are part of a system of reforms to streamline the process of conducting clinical trials in the NHS, as part of the NIHR goal of creating a world class clinical research environment.

A series of model agreements has been drawn up by the UK Health Departments, the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA), and the Association for British Healthcare Industries (ABHI), as appropriate, and approved for use in unmodified format by representatives of the NHS and universities.

Model Clinical Trials Agreement (mCTA) for pharmaceutical research

In November 2005, the Clinical Research Working Group of the Pharmaceutical Industry Competitiveness Task Force commissioned a thorough review and revision of the model Clinical Trial Agreement (mCTA). That agreement, published by the Department of Health and ABPI in February 2003, is used as the core of their CTAs by the majority of pharmaceutical companies operating in the UK.

The aim was to build on the recent experiences of pharmaceutical and biotech companies and NHS hospitals to produce a model agreement that all companies sponsoring trials, and NHS hospitals carrying them out, would regard as acceptable for use without any modification (i.e., without modification except for the addition of details of the contracting parties, the trial protocol and specific financial arrangements).

The new version had to reflect a number of recent changes of a 'regulatory' nature:

  • EU Clinical Trial and Good Clinical Practice (GCP) Directives
  • industry undertakings with respect to trial registration and publication of results
  • the development of NHS Foundation Trusts
  • changes to the NHS Research Governance Framework

In addition, an extensive consultation with pharmaceutical and biopharmaceutical companies and R and D offices in research-active NHS Trusts and Foundation Trusts had identified issues that create delays to contract sign-off and trial initiation.

The key areas of concern included:

  • liabilities, indemnities and insurance
  • excluding references to foreign laws
  • handling of protocol amendments and their financial implications
  • handling of intellectual property (IP) provisions
  • data protection and freedom of information requests
  • dispute resolution procedures

Detailed discussions were also held with representatives of medical school Deans to ensure that universities, who employ many investigators involved in clinical trials, are fully informed about projects in which their staff are involved in their honorary NHS capacity, and can recover costs and overheads appropriately. Following this consultation process, the new consensus contract template the "NHS-ABPI-BIA model Clinical Trial Agreement 2006" was issued. The mCTA covers all the issues that sponsor companies and NHS bodies believe are essential to represent the legal relationship between them.

It is intended that the mCTA be used routinely without modification by all pharmaceutical and biopharmaceutical sponsors of contract clinical trials and the NHS hospitals in which patients are recruited.

The documents are endorsed for use without modification by Health Departments throughout the UK, the trade bodies (ABPI and BIA), the NHS Confederation, the NHS R and D Forum, the UK Clinical Research Collaboration, the Foundation Trust regulator (Monitor), and the Council of Heads of Medical Schools.

Versions have been also prepared that reflect the special governance and legal arrangements of Scotland, Northern Ireland and Wales.

The mCTA is designed to simplify and therefore speed up the process for signing off and initiating trials involving NHS patients in NHS hospitals. It removes any need for either sponsors or hospitals to undertake further legal review of contracts in response to another party proposing modifications.

Like the ABPI Form of Indemnity, use of the Agreement is not mandatory, but it is expected that neither NHS bodies that want to carry out trials nor sponsors keen to complete drug development programmes would risk the delays that would result from the introduction of changes.

The new Contract Research Organisations model Clinical Trial Agreement (CRO mCTA)

Following publication of the mCTA, negotiations with pharmaceutical companies and Contract Research Organisations (CROs) took place to devise an appropriate format for agreements between NHS Trusts, pharma sponsors of clinical trials and the CROs to which the management of the trials is often outsourced. A number of questions arise when trials are managed by CROs, such as whether the sponsor or the CRO is the party with which the Trust must interact over specific points.   Sponsors often outsource trials to CROs to simplify their management and therefore most of the trust’s dealings are likely to be with the CRO, but there are a number of issues over which sponsors need to maintain direct involvement. These include:

  • ABPI indemnity
  • intellectual property
  • publication
  • Freedom of Information Act enquiries

For reasons set out in the guidance, it was concluded that a tripartite agreement was the appropriate format for this purpose.  The CRO mCTA contains fundamentally the same provisions as the 2006 mCTA, so the information above covers this agreement too.  However, in respect of a number of points, in devising the trial-specific agreement the parties have to consider whether it is the sponsor or the CRO (or both) with which the NHS Trust interacts. These options are set out in the model agreement. Therefore, converting the model agreement into a trial-specific agreement is a slightly more complex process than it is with the bipartite mCTA.

Model Clinical Investigation Agreement for medical technology industry sponsored research in NHS hospitals

Supporting research in collaboration with the medical technology industry as well as the pharmaceutical and biopharmaceutical industry is at the heart of the government’s R&D strategy Best Research for Best Health. The Healthcare Industries’ Taskforce (HITF) identified building R&D capacity as one of the key outputs to take forward in its programme for action and the mCIA was recognised as an important output from this work. 

The mCIA is designed to simplify and therefore speed up the process for signing off and initiating trials involving NHS patients in NHS hospitals. It removes any need for either sponsors or hospitals to undertake further legal review of contracts in response to another party proposing modifications. It is intended that the mCIA be used routinely without modification by all medical technology industry sponsors of contract clinical research in NHS hospitals in which NHS patients are recruited. Versions have been prepared that reflect the special governance and legal arrangements of Scotland, Northern Ireland and Wales.

The documents are endorsed for use without modification by the four UK Health Departments and by the Association of British Healthcare Industries, the NHS Confederation, the NHS Forum, the Medical Schools’ Council, the UK Clinical Research Collaboration, the Institute for Clinical Research, and by the Ministerial Medical Technology Strategy Group, who will review experience with its use after one year.

Discussions on the scope and format of the mCIA were initiated with representatives of the ABHI and the Medicines and Healthcare products Regulatory Agency. In depth discussions were also held with representatives of NHS Trusts, the four UK Health Departments, and NHS Innovation Hubs. 

The Agreement has been designed to provide for transparency, probity, and the protection of all relevant interests with terms that are legally robust.

The Agreement is not appropriate for use in collaborative clinical research, where investigators employed by trusts or universities are involved collaboratively in the design and development of medical devices or the planning and research design aspects of contract commercial investigations. Model Agreements for use in collaborative clinical research are being considered for development by the UK Clinical Research Collaboration. The Agreement is also not appropriate for use in the performance evaluation of in vitro diagnostic medical devices.

Use of the mCIA is not mandatory, but it is expected that neither NHS bodies that want to carry out trials nor sponsors keen to complete device studies would risk the delays that would result from the introduction of changes.

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