ABPI Guidelines for Phase 1 Clinical Trials (PDF

Foreword
The development of new and better medicines is
vital for public health. A key step in taking
potential new medicines from the laboratory to
humans is the phase 1 clinical trial, when they
are given to humans for the first time. Phase 1 is
the gateway between scientific research and
clinical practice.
The phase 1 trial falls within the realm of
experimental science, and requires a range
of skills and expertise of the highest standard.
Confidence in the results depends upon the
clarity and understanding of the questions
asked, and upon the quality of the trial
designed to answer them. However, the
safety and well-being of the subjects -
whether they be healthy individuals or
patients - must always have priority.
The translation of advances in the biological
sciences into health gains, via the development
of new medicines, is likely to occur at an
increasing pace in the coming years. New
medicines will be based on progressively
refined biological and biochemical discoveries.
There may be no prior experience in humans of
many of the new types of medicine that advances
in molecular biology should yield. The
challenges for phase 1 trials include: finding
methods to assess the potency and effectiveness
© Association of the British Pharmaceutical Industry 2007
of these new medicines; sharing of safety
information; calculation of the starting dose;
design of 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.
This 2007 edition of the ABPI Guidelines for
Phase 1 Clinical Trials is science based, and is
a remarkably thorough and notably clear
compilation of up-to-date information and
guidance on best practice. It covers all of the
key points, and warrants close reading and
frequent reference by those involved in the
development, investigation and regulation of
new medicines. As we enter an era of high
expectation in the provision of much-needed
new medicines, the ABPI is to be commended
on the timely production of professional
guidance that will underpin the safe and
effective conduct of future phase 1 trials.
Sir Gordon Duff
Florey Professor of Molecular Medicine,
University of Sheffield
Chairman, National Biological Standards Board
Chairman, Commission on Human Medicines
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