Dear Mrs Thyer,

Thank you for your letter of 6 August and for the information you gave about the roles of sponsors, ethics committees and the Agency in organising clinical trials. In the light of the evidence from Drs Bohaychuk, Ball and colleagues (GCRPC), the implication seems to be that patients face risks in clinical trials in spite of the best efforts of many.

It was disappointing to get no response on the main question to the Health Secretary - i.e. what recommendations might be given to patients invited to participate in clinical trials? Apart from indicating support for some legal basis for compulsory GCP inspection, your letter suggested no cause for concern. Thus it was left to the Association of the British Pharmaceutical Industry to give sweeping but inexplicable assurances that all is well, and to emphasise that people involved in clinical trials are not at risk.

In the light of what you say and don't say about the MCA's present limited role in ensuring compliance with good clinical practice (GCP) guidelines, please will the MCA consider modifying the information on its website? It seems far fetched: "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 trial research".

Your letter did not indicate how many inspections were carried out at the invitation of the sponsor companies, and how many were 'for cause' inspections where there was suspicion of scientific misconduct or fraud. I believe most companies volunteered to be inspected, and paid a fee to the MCA; I would appreciate further information on this point. Perhaps you could also provide some information about the inspection findings? At a BIRA/ACRPI symposium in April 1998, it was suggested that the MCA thought that "not many companies would qualify for UK GCP certificates", if they existed, and that "serious inspection findings in 1997 totalled approximately 274, an average of 40 per company inspected". If most companies volunteered for inspection, these results are presumably much better than average. Could you please let me have the corresponding figures for inspections carried out to date?

Your letter referred to Dr Bohaychuk's "useful editorial" but otherwise suggested the MCA had no view about the GCRPC audit findings. Equally, there was no reference in your letter to data from audits of clinical trials routinely conducted by the US Food & Drug Administrations. Are these data not relevant? Is there really no evidence available, in whatever form, to distinguish between what the ABPI says and the MCA doesn't?

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