The Association of the British Pharmaceutical Industry (ABPI) has updated its guidelines on Phase I clinical trials to reflect changes in the UK’s regulatory framework since the guidelines were last published in 2007.
Since then, the ABPI points out, “a considerable amount of what previously constituted guidance has now become requirement”.
The revised Guidelines for Phase 1 Clinical Trials are also a response to the accelerating pace of innovation in medicinal science, with all the complexity and risks that implies.
New medicines “will be based on progressively refined biological and biochemical insights”, states Sir Gordon Duff, chairman of the UK Commission on Human Medicines, in the foreword to the guidelines. As such, there “may be no prior experience in humans of many of the new types of medicine that advances in molecular pharmacology should yield”.
The challenges for Phase I trials, Sir Gordon notes, include finding methods to assess the potency and effectiveness of new medicines; sharing safety information; calculating the starting dose; designing dose-escalation protocols; and, “in the interests of the well-being and safety of the subjects, ever-vigilant attention to risk reduction and risk management in the conduct of the trial”.
The first edition of the ABPI’s Phase I guidelines came out in 1970. They were subsequently revised in 1977 and in 1988, with the latter update producing two sets of guidelines, one for procedures and one for Phase I facilities.
In 1986 the Royal College of Physicians (RCP) published a report on research in
healthy volunteers, which has never been revised, the ABPI says. The 1988 revision of the association’s Phase I guidelines did, however, take the RCP report into account.
As the ABPI explains, these previous editions were written when many member companies had their own facilities and used their own staff as a source of healthy volunteers. Nowadays, contract research organisations conduct most of the Phase I trials in the UK, while many of the trial sponsors are from other countries.
A major revision of the Phase I guidelines in 2007 updated and expanded the sections on premises; facilities equipment; staff emergency procedures and equipment; pharmacies and laboratories; records and archiving; justification for using healthy volunteers; recruitment and payment of trial subjects; frequency of volunteering; ethics committees; and compensation.
New sections were added to reflect significant changes in the UK regulations and the ways in which Phase I trials were being conducted.
Together with the rapid pace of regulatory development, in recent years an “impressive range” of guidance documents dealing with various aspects of clinical trials has been published by health authorities and other stakeholders around the world, the ABPI points out in explaining the reasons for the latest update.
In this context, it says, “many readers still feel the benefit from a comprehensive, largely jargon-free document that outlines the framework within which Phase I research is conducted and provides pointers for further, more in-depth reading”.
The new edition incorporates the latest ABPI guidance on clinical-trial insurance and subject compensation.
It also “responds to the feedback received from many stakeholders, several of which had commented that the guidelines had become over-prescriptive in places, especially in the sections on premises and facilities”, the association comments.
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