ABPI Publish Updated Phase I Clinical Trial Guidelines

The Association of the British Pharmaceutical Industry (ABPI) amended their guidelines on Phase I trials on Tuesday to echo alterations in the UK’s regulatory framework since the previous guidelines were issued in 2007.

Since 2007, the association notes that “a considerable amount of what previously constituted guidance has now become requirement.”

The updated guidelines are also a reaction to the quickening speed of innovation in medicinal science, with all the complication and risks that it denotes.

New medicines “will be based on progressively refined biological and biochemical insights,” commented Sir Gordon Duff, chairman of the UK Commission on Human Medicines, in the preface to the revised guidelines.  Therefore, 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 stated, include finding methods to assess the potency and effectiveness of new treatments; 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.”

Past Changes

The initial version of the ABPI’s Phase I guidelines were released in 1970.  They were later revised in 1977 and in 1988, with the latter update creating 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 updated.  The 1988 revision of the Phase I guidelines did, however, take the RCP report into consideration.

As the ABPI explains, the past editions were written when several member companies had their own facilities and used their own staff as a source of healthy volunteers.  Today, contract research organisations conduct most of the Phase I trials in the UK, while much of the clinical trial funding comes from other countries.

A significant amendment of the Phase I guidelines in 2007 updated and grew 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 mirror the major changes in the UK regulations and the ways in which Phase I trials were being conducted.

Latest Revision

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 noted that “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 integrates 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 of the British Pharmaceutical Industry added.


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