Rawson N S, West R, Appel W C
School of Pharmacy, Memorial University of Newfoundland, Health Sciences Centre, St John's, Canada.
Can J Clin Pharmacol. 2000 Winter;7(4):185-90.
Conditional release is the approval of a new drug onto the market, subject to specific conditions relating to effectiveness and safety that, if achieved, will lead to full approval. Conditional approval of a new drug, during which time it is used in normal clinical practice, should allow the collection of data on effectiveness and safety to provide a genuine cost effectiveness evaluation. Proposals put forward in 1977 in the United Kingdom for approving a drug on a conditional basis while monitoring for adverse drug reactions are examined, and issues that would affect a present day conditional release scheme are identified. These issues are: who would do the evaluation and who would pay for it; how would patients be identified and registered; would all new drugs be monitored and for how long; what data would be reported and evaluated; and who would do the reporting? How a conditional release scheme would work in Canada in light of these questions is considered and a method based on pharmacists registering patients and on physicians and/or patients reporting data to an independent organization funded by governments and the pharmaceutical industry is outlined. Under certain conditions, conditional release would provide the information to allow true cost effectiveness and safety assessments instead of the current inadequate predictions based on efficacy and safety data from clinical trials. It is important that academics and drug approval and monitoring agencies work together to develop active systems to improve the postapproval evaluation of effectiveness, safety and cost effectiveness of new drugs in Canada.
有条件批准是指一种新药在满足与有效性和安全性相关的特定条件后被批准上市，若能满足这些条件，将可获得完全批准。在新药有条件批准期间，其在正常临床实践中使用，应能收集到有效性和安全性数据，以便进行真正的成本效益评估。本文审视了1977年英国提出的在监测药物不良反应的同时有条件批准药物的提议，并确定了会影响当今有条件批准计划的问题。这些问题包括：谁来进行评估以及谁来为此付费；如何识别和登记患者；是否对所有新药进行监测以及监测多久；需要报告和评估哪些数据；以及谁来进行报告？鉴于这些问题，本文考虑了有条件批准计划在加拿大如何实施，并概述了一种基于药剂师登记患者以及医生和/或患者向由政府和制药行业资助的独立组织报告数据的方法。在某些条件下，有条件批准将提供信息，以进行真正的成本效益和安全性评估，而不是基于当前临床试验的疗效和安全性数据进行的不充分预测。学术界与药物批准和监测机构共同努力开发积极的系统，以改进加拿大新药批准后有效性、安全性和成本效益的评估，这一点非常重要。
