Clinical trials in the UK


Last updated July 2008

The regulation of clinical trials
The BMA's Public Information Unit receives many queries about clinical trials.

Clinical trials are investigations that test actual and potential treatments on volunteers to see if they do more good than harm compared to alternatives. Many trials are limited to specific types of patients and more trials are run for some kinds of diseases than for others (cancer, for example).

In May 2004, new regulations came into force in the UK to better protect the rights, safety and well-being of patients taking part in clinical trials of new medicines. These measures are based on European legislation aimed at harmonising standards for clinical trials on new medicines throughout the European Union (Clinical Trials Directive (2001/20/EC).

In 2006, this legislation was further amended to implement the European Commission Directive 2005/28/EC1 (the Good Clinical Practice (GCP) Directive).

Provisions implementing the GCP Directive cover issues such as the content and presentation of the investigator's brochure; the qualifications and procedures for inspectors; the retention of documents and archiving; and the sharing of information between ethics committees and the licensing authority.

There is information about the new regulations on the MHRA website.

The Department of Health (DH) and the Medical Research Council have produced a Clinical Trials Tool Kit to help organisations meet the requirements of the EU Clinical Trials Directive in the UK (including the need to properly protect patients).

Following the events which took place at Northwick Park Hospital (March 2006), where some volunteers became seriously ill while taking part in a clinical trial, the Department of Health's Expert Scientific Group (ESG) published a final report on Phase 1 clinical trials in December 2006, putting forward recommendations to improve the safety of clinical drug trials. (Phase 1 clinical trials cover the stage at which new medicines are given to humans for the first time).

In 2007, the Association of the British Pharmaceutical Industry (APBI) also published revised guidelines on the conduct of Phase 1 clinical trials.

In 2004, the BMA’s Board of Science produced an internet resource on clinical trials, intended for doctors, other health professionals and the public. This internet resource on clinical trials includes a section on the regulation of clinical trials.

Clinical trial registers
Information about completed and ongoing randomised controlled clinical trials in the UK and abroad is available on the Current Controlled Trials (CCT) website. Current Controlled Trials Ltd is part of the Science Navigation Group of biomedical publishing companies and is not commercially funded. The CCT website provides access to the following databases of clinical trials:
  • The International Standard Randomised Controlled Trial Number (ISRCTN) Register. This database contains details of thousands of clinical trials with a unique trial ID number; this provides a means of identifying and tracking a trial throughout its progress. All ISRCTN trialshave been approved by the World Health Organisation's Ethics Review Board and are pooled into the WHO's trials search portal on a weekly basis.
  • The metaRegister of Controlled Trials (mRCT). This is a platform which brings together different databases of ongoing randomised controlled trials (RCTs) in all areas of healthcare. It combines registers held by public, charitable and commercial sponsors of ongoing and completed clinical trials.
    The mRCT was set up to provide a wide range of groups, including patients, with information about trials in which they can participate, or contribute to in other ways; it can be searched using key words.

    The metaRegister of Controlled Trials includes the full ISRCTN Register (see above); randomised controlled trials from the US Register ClinicalTrials.gov; and customised trial databases extracted from the ISRCTN Register for organisations wishing to have their trials listed separately: the Medical Research Council, the Leukaemia Research Fund, the Wellcome Trust, Action Medical Research, the NHS Health Technology Assessment Programme (HTA), and UK-related trials extracted from the ISRCTN Register (the UK Clinical Trials Gateway).

There are several other organisations which have compiled their own clinical trial databases:
  • Aidsmap is a website run by several leading HIV/AIDS support groups; it provides information on taking part in HIV-related clinical trials and a database of relevant UK trials.
  • CancerBACUP is a cancer charity which provides information and services to cancer patients, their friends and families. Their website provides comprehensive information on clinical trials in cancer research. CancerBACUP’s Telephone Information Helpline is (0808) 800 1234.
  • CancerHelp UK is a free information service about cancer and cancer care for patients, their families and the lay public, produced by Cancer Research UK. Their clinical trials database provides information on ongoing UK clinical trials for new cancer treatments.
  • The Medical Research Council Clinical Trials Unit (CTU) was formed by the amalgamation of the MRC HIV Clinical Trials Centre and the MRC Cancer Trials Office. It undertakes trials covering a wide range of diseases, including cancer, HIV, rheumatoid arthritis, respiratory disorders, infectious diseases and haematological disease.
    The MRC's Clinical Trials Unit website provides information on their ongoing trials and includes a FAQ on clinical trials and a searchable database of their trials.
  • The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) launched a clinical trials internet resource in September 2005, containing information on on-going clinical trials being conducted by their members worldwide.

The website also enables users to access the results of clinical trials which have already been completed (by doing a keyword search entering a disease type). Users now have to register to use this service.
  • United Kingdom Clinical Research Network (UKCRN). The UKCRN Portfolio comprises the National Institute for Health Research (NIHR) portfolio of clinical research projects in England, and the corresponding research portfolios of Northern Ireland, Scotland and Wales.
    Until December 2007, the National Research Register (NRR) - now archived - provided information on research taking place in NHS organisations in England, Scotland and Wales. However, the development of Clinical Research Networks has shifted responsibility for registering eligible research from NHS organisations to the researcher and the topic network. Data is therefore no longer submitted or collected from the NHS as a whole.

    The UKCRN Portfolio has a searchable database of ongoing research projects, broken down by health topic, (eg cancer, diabetes, neurological, stroke), including trials in the process of being set up, trials recruiting for patients, and those trials that are closed or suspended.
    The former NHS Trusts Clinical Trials Register set up in 2003, (which lists more than 1,600 NHS trials but which has now been superceded by the UKCRN Portfolio), has been archived; however, users can still read the latest on those trials in the ISRCTN Register by typing in the relevant IRSCTN trial ID.

Other useful sources of information on clinical trials

Additional sources of information on clinical trials include:

  • HealthWatch; this is a charity that supports and encourages scientific testing of conventional, complementary and alternative medicine and therapies. Healthwatch aims to provide better public protection from unproven health claims and to encourage a better understanding among health professionals and the public of the need for clinical trials. HealthWatch website.
  • The Clinical Contract Research Association (CCRA); this body represents independent clinical research contractors and those in associated industries. The CCRA provides guidance on clinical trials with a FAQ section and separate guidance on participating in clinical trials (including advice for volunteers and patients). CCRA website.

(Please note that the websites listed above are unrelated to the BMA and their inclusion here does not imply BMA recognition or approval. We can accept no responsibility for their content).

As well as discussing how to increase patient participation, the BMA’s internet resource looks at different types of clinical trials, ethics and good practice in conducting a trial and how to address patients’ concerns about participation. The involvement of doctors and patients section, in particular, looks at the design of trials and at factors for potential participants taking part in trials to bear in mind.

Generally speaking, a patient wishing to participate in a clinical trial will need to be referred by a doctor.

© British Medical Association 2008

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