Standardization of early drug trials in allergic diseases (with reference to a trial of doxantrazole)

Attention is drawn to the long wait in certain countries before new drugs and other therapies for the treatment of allergic diseases are approved by the local authorities, even when good trials with them have been carried out elsewhere. The main reasons for requiring repeat trials are poor original case selection and inadequate parameters of assessment, particularly environmental variations. The results of re-assessing patients who in the previous year had undergone a trial of a new chromoglycate-like drug (Doxantrazole) are used to illustrate the need to introduce standard basic requirements when new drugs and other agents are being tested in allergic diseases. A suggested format of such requirements is presented.