Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0642
Facsimile 0171- 273 0286 .
13 October 1999

Dear Mr Medawar,

Thank you for your letter of 13 August about clinical trials and Good Clinical Practice (GCP) inspections. I am sorry, because of my absence on leave, not to have replied sooner. Taking the questions you raise in turn:

Advice to patients

The responsibility for ensuring that information is supplied to those patients who are considering entering a clinical trial rests with the trial sponsor, the investigator and the relevant Ethics Committee(s). Whilst the MCA does not have direct contact with patients involved in clinical trials, it expects sponsors to work in accordance with the International Committee on Harmonisation (ICH) Guidance Note on Good Clinical Practice (copy enclosed). Section 2.3 of that Note states that "...the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society". Section 4.8 of that Note provides details of the type of information which should be supplied to patients to enable them to make an informed decision concerning their participation in a trial.

Information currently on MCA's website about GCP inspections

You asked if we would consider modifying the statement that "GCP inspectors assess compliance with the requirements of GCP guidelines and regulations, and this involves conducting on-site inspections at pharmaceutical sponsor companies, contract research organisations and other facilities involved in clinical research." This is factually correct, although it does not mention that GCP inspections are currently conducted on a voluntary basis only. The MCA's annual report for 1998/99, which provides further information about inspections, refers to the voluntary basis of inspections and we will also include that information on the website.

Information about inspections

My reply of 6th August gave information about the number of inspections conducted by the GCP Compliance Unit. As indicated then and in this year's annual report, the Unit carries out all GCP inspections, including "for cause" inspections, on a voluntary basis. The term "for cause" does not necessarily mean there has been suspicion of scientific misconduct or fraud. Rather, the term describes inspections which have been triggered for a particular reason, such as the assessor seeking further information. At the present time, these inspections are still voluntary and agreed to by the sponsor, research organisation or investigator. You are right that most companies do pay the MCA a fee for inspections. However, the MCA does not normally charge where inspections are "for cause."

Information about inspection Findings

You mentioned MCA figures for 1997 which were cited at a symposium in April 1998 and asked for corresponding figures to date. Those 1997 figures represented findings from the very earliest inspections when the Unit was in its infancy. Since that time, the classification system has been under review and the data are not in a form that can be used for comparison. We are currently consulting our EU partners on a new classification system which will enable the Unit to collect and analyse inspection data in a much more structured way. From the inspection programme, deficiencies have on occasion been identified in relation to the responsibilities of the sponsors, ethics committees and clinical investigators. The GCP Compliance Unit requires sponsors to respond to inspection findings and to correct deficiencies.

You asked about the relevance of other data. The Compliance Unit keeps abreast of published data from a number of regulatory authorities, including the FDA and other sources. Details of FDA GCP inspections conducted at UK sites can be obtained from their website.

Yours sincerely
Mrs Anne Thyer
Executive Support
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