§ Dr. Roger Thomasasked the Secretary of State for Social Services if he will consideer stricter regulations for the conduct of drug trials by general practitioners on their registered patients when the drug is being used in practice at a comparatively early stage of its clinical usage.
§ Dr. VaughanA few drugs are tested in general practice at a relatively late stage in their development.. but this may only be done with the knowledge of the licensing authority. Usually the trials conducted by general practitioners are for uses for which the product licence has already been granted by the licensing authority after consideration of its safety, quality and efficacy. In such cases separate approval of the trial is not required from the licensing authority. A code of practice is being prepared by the Association of the British Pharmaceutical Industry to guide pharmaceutical companies and members of the medical profession on the procedures for organising these trials. I hope to see included in this that the trials have prior approval of an ethical committee. In the latter case there seems no reason to distinguish between old and new products.