The rights of patients versus the obligations to sponsors in clinical trials.

A recent exchange of Letters to the Editor in The Lancet [1,2], has made it evident that the Note for Guidance on "Good Clinical Practice for Trials on Medicinal Products in the European Community" [3], does not provide sufficient advice on the relation between the patient or volunteer on the one hand and the sponsor and his non-physician executive (e.g. monitors) on the other. Although there is no doubt that the patient's interests as represented by the physician have absolute precedence, the latter's responsibilities are listed after those of the sponsor and monitor. Accordingly, two important rights of the patient, i.e. that of the absolute confidentiality of his history and his clinical data as well as of the right to determine with his physician when to terminate his treatment, are insufficiently dealt with. As has been emphasized by Deutsch et al. [1], the non-physician monitor should, according to the guidelines, "assure .. i that informed consent is being obtained and recorded from all patients". Since the signature of the patient is to be proof of his consent, the confidentiality is already broken. He should further "check the CRF entries with the source documents", which invariably contain the names of patients at many points, and it is impossible to ensure that all these are blacked out. The Guidelines put the responsibility for discontinuing the trial squarely with the sponsor (2.3 c). The reasons for discontinuance may relate to the subject's safety but they may equally well be organisational or even commercial. There may be occasions where the abrupt discontinuation of drug treatment may be detrimental to the patient or where the change to a replacement medicine may be not without risk to the patient. In diseases in which the drug on trial may be the first efficacious agent to become available (e.g. erythropoietin) a premature termination