主页 > 医药生命 >
【技术产业】吸取TGN药物试验教训，英国加强I期
By Kirsty Barnes
21/08/2007 - The Association of the British Pharmaceutical Industry (ABPI) has now published revised guidelines for Phase I trials in the UK.
The new guidance is part of an ongoing effort to prevent a repeat of last year's TGN 1412 drug trial disaster, where all six subjects who received the experimental drug experienced severe adverse reactions.
"Phase I trials are the gateway between scientific research and clinical practice. This new edition is a clear compilation of comprehensive guidance on best practice", said the ABPI.
According to the industry body, its guidelines for Phase I trials "have long been used as a reference by those running such trials, and cover the responsibilities of the principal investigator (doctor), nurses and support staff, pharmacy, manufacture and site facilities".
The new guidelines were established on the advice of the Expert Working Group (EWG), chaired by Professor Sir Gordon Duff and set up by the Secretary of State for Health to provide an independent expert review of the TGN 1412 incident.
Specific issues addressed in the ABPI's latest version include best practices for the administration and dosing of Phase I compounds, along with the decision as to whether a Phase I trial should be done in healthy subjects, or those suffering from the illness that that drug is designed to treat.
Sir Duff said the new guidelines, which can be viewed here, "warrant close reading and frequent reference by those involved in the development, investigation and regulation of new medicines".
The TGN 1412 drug trial disaster rocked the clinical trials industry last year and various interim safety measures have been in place for Phase I trials in the UK ever since, however, after a year of international expert and industry consultation, such measures are only being finalised and implemented by industry organisations such as the ABPI and the Medicines and Healthcare products Regulatory Agency (MHRA) this year.
In April the MHRA implemented new review procedures for applications to run first-in-man clinical trials for 'high risk' compounds, also on the back of Sir Duff and co's advice.
A key feature of the new procedure is the review of certain first-in-man trial applications by an Expert Advisory Group (AEG), followed by the Commission on Human Medicines (CHM). April 18 was the date of the first official AEG meeting.
For the purpose of the new regulations, high risk compounds can fall into one of three categories: a biologic drug with a novel mechanism of action; an agent (usually biologic) which is highly species specific, meaning that there is a high likelihood that the animal model used may not be predictive of the response in man; and/or any new drug that is directed against the immune system. The majority of new compounds do not fit into any of these categories and were therefore unaffected.
Meanwhile, Europe's drug regulator, EMEA is currently in the process of issuing a guideline on the matter, which it is believed will end up very similar to the system implemented by the MHRA, and the US Food and Drug Administration (FDA), although less advanced in its dealing with this issue, is expected to eventually follow suit. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 UK tightens Phase I guidelines
英国加强对I期临床实验的指导
By Kirsty Barnes
Kirsty Barnes报道
21/08/2007 - The Association of the British Pharmaceutical Industry (ABPI) has now published revised guidelines for Phase I trials in the UK.
21/08/2007 –英国制药工业协会（ABPI）刚刚发布了在英国进行I期临床实验的指导原则的修订稿。
The new guidance is part of an ongoing effort to prevent a repeat of last year's TGN 1412 drug trial disaster, where all six subjects who received the experimental drug experienced severe adverse reactions.
新的指导原则是为了避免再次发生去年TGN 1412药物实验灾难的努力的一部分，在那次实验中6个接受了实验药物的组中均发生了严重的副作用。
"Phase I trials are the gateway between scientific research and clinical practice. This new edition is a clear compilation of comprehensive guidance on best practice", said the ABPI.
“I期实验是科学研究同临床实践的结合点。这个新的（指导原则）版本是为了更好进行实践而（对现有资料）进行的清晰而全面的总结。”
According to the industry body, its guidelines for Phase I trials "have long been used as a reference by those running such trials, and cover the responsibilities of the principal investigator (doctor), nurses and support staff, pharmacy, manufacture and site facilities".
对于医药工业界来说，I期实验的指导原则“被长期作为参考指导该类实验，并且涵盖了主要研究者（医生）、护士、支持人员、药房、生产厂及实验基地的责任”。
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-02-14 18:24
医学,生命科学网