Ford R M
Ann Allergy. 1978 Jan;40(1):25-7.
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.
需要注意的是,在某些国家,即使在其他地方已经对治疗过敏性疾病的新药和其他疗法进行了良好的试验,但在当地获得批准之前仍需漫长等待。要求重复试验的主要原因是最初病例选择不当以及评估参数不足,尤其是环境差异。重新评估前一年接受过一种新的色甘酸类似药物(多克沙唑)试验的患者的结果,用以说明在对过敏性疾病的新药和其他药物进行测试时引入标准基本要求的必要性。本文还提出了此类要求的建议格式。