ABPI Guidelines for Phase 1 Clinical Trials (PDF

Preface
The first edition of these ABPI guidelines was
published in 1970. 1 They were revised in 1977 2
and 1988. The 1988 revision resulted in two sets
of guidelines, one for procedures 3 and another
for facilities. 4 In 1986, the Royal College of
Physicians (RCP) published a report on research
in healthy volunteers, 5 which has never been
revised. But the 1988 revision of the ABPI
guidelines took the RCP report into account.
Previous editions were written when many ABPI
member companies had their own facilities and
used their own staff as a source of healthy
volunteers. Nowadays, contract research
organisations (CROs) do most of the phase 1
trials in the UK, 6 and many sponsors are from
countries outside the UK.
Years after the 1988 editions, they are still the
main source of information about the premises,
facilities, equipment, staff and procedures
required to do phase 1 trials. Also, ethics
committees expect sponsors to abide by the ABPI
policy on compensation of trial subjects. In this
new edition, all sections have been revised:
premises; facilities; equipment; staff; emergency
procedures and equipment; pharmacy and
laboratory; records and archiving; justification for
studying healthy subjects; recruitment and
payment of subjects; frequency of volunteering;
ethics committee; and compensation. And
various new sections have been added to cover
changes to the regulations and the ways in which
phase 1 trials are done. Some things in previous
editions are now legal requirements, and not
guidelines. However, that word is kept in
the title.
All sorts of people - sponsors; investigators in the
private and public sectors; monitors; auditors;
ethics committees; regulatory authorities; and
© Association of the British Pharmaceutical Industry 2007
sometimes even trial subjects - were referred to
the previous editions. The hope is that this new
edition will be just as widely used. With that in
mind, jargon is kept to a minimum or explained
in the text or glossary.
Finally, in line with the references cited below, in
this new edition:
• Potential new medicines are called
investigational medicinal products (IMPs). 7
• Clinical trials of an IMP that do not benefit
subjects - whether they be healthy subjects or
patients - are called phase 1 or nontherapeutic
trials. 7
• The premises where trials are done are called
phase 1 units, or simply units.
• People who take part in clinical trials are
called subjects: 7 healthy subjects when they
are truly healthy, and patients when they
have the disease for which the IMP is being
developed.
• The discipline that underpins phase 1 trials is
called clinical or human pharmacology. 8,9
Written and compiled for the ABPI by:
Malcolm Boyce
Association for Human Pharmacology in the
Pharmaceutical Industry (AHPPI)
www.ahppi.org.uk
Acknowledgements:
The following commented on earlier drafts: ABPI
Guidelines Working Group; ABPI Experimental
Medicine Group; AHPPI; Academy of Medical
Sciences ; AREC; Faculty of Pharmaceutical
Medicine of RCP; GTAC; ICR, Joint Clinical Trials
Insurance Taskforce; MHRA; NRES; Resuscitation
Council (UK); and work colleagues.
4