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UK tightens Phase I guidelines

By Kirsty Barnes , 21-Aug-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.

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