Clinical Trials (Hansard, 18 November 1996)

§ Mr. Simon Hughes
To ask the Secretary of State for Health what monitoring procedures his Department and the Medicines Control Agency follow to ensure that the conduct of phase 1 clinical trials is in compliance with good clinical practice guidelines. [3872]

§ Mr. Malone
In accordance with advice from the Medicines Commission, phase 1 clinical trials are self-regulated by the professional concerned. The Department and its Medicines Control Agency have no procedures to monitor the conduct of these trials.

§ Mr. Hughes
To ask the Secretary of State for Health what responsibility the Licensing Authority has for the conduct of phase 1 clinical trials in healthy volunteers. [3877]

§ Mr. Horam
Studies on healthy volunteers are not clinical trials within the definition of the Medicines Act 1968 and therefore are not subject to regulation by the licensing authority.
In the United Kingdom, studies on healthy volunteers are self-regulated by the medical profession and pharmaceutical industry. The Association of the British Pharmaceutical Industry established a committee in 1969 to investigate and advise on medical experiments involving pharmaceutical company staff volunteers and published a set of guidelines in 1970 which were updated in 1984 and 1990. The Royal College of Physicians published a report, "Research on Healthy Volunteers", October 1986 which made a number of recommendations to those involved in conducting healthy volunteer studies.

§ Mr. Hughes
To ask the Secretary of State for Health (1) what procedures(a) his Department, (b) the Licensing Authority and (c) the Medicines Control Agency follow to ensure safety of volunteers in phase 1 clinical trials; [3878]
408W
(2) what procedures (a) his Department and (b) the Medicines Control Agency follow to ensure appropriate monitoring of ethics committees considering and approving phase 1 clinical trials. [3879]

§ Mr. Horam
Most phase 1 clinical trials are carried out for pharmaceutical companies. Under Association of the British Pharmaceutical Industry guidelines they must first have obtained the approval of an independent research ethics committee. These guidelines require independent research ethics committees to prepare an annual report in accordance with recommendations from the Royal College of Physicians. Where, less commonly, it is proposed to undertake these trials in the national health service, the approval of a local research ethics committee must be obtained. The Department of Health issued guidance to the NHS on the operation of LRECs in 1991, HSG(91)5, copies of which were placed in the Library.