ABSTRACT
General practitioners are frequently invited to participate in the trial of a drug, involving their own patients. The relationship between a patient and the doctor is often very personal and intense in general practice. The most common and simple design is a comparison of treatment with the study drug in a random group of patients with treatment of another random group given the current 'best buy' drug. The phases of investigation that a new drug has to pass through before it is licensed for routine prescription are complex. A system for breaking the 'blinding' code has to be installed, since physicians treating the patient for co-existing disease will need to know what drugs are being administered. Double blinding has become a standard requirement of most controlled trials. Every trial on National Health Service (NHS) patient or involving NHS premises, staff or equipment requires ethical approval by a Local Research Ethics Committee (LREC).
