Clinical trial pharmacy services guidance launched
All pharmacy staff should become familiar with the guidance |
New practice guidance on clinical trial pharmacy services was launched this week. Advice on pharmacy staff and facilities, ethics committees
and investigational medicinal product management is included in the guidance,
which has been produced as a result of
a collaboration between the Royal Pharmaceutical Society and the Institute
of Clinical Research.
“Key recommendations are that designated pharmacy staff should
look after all aspects of clinical trials in dedicated facilities and
proper management
structures including suitable archiving should be put in place,” said
John Gilroy, chairman of the Institute of Clinical Research Pharmacy
Subcommittee. He added that the guidance highlights the importance of
pharmacy clinical trials personnel having good working relationships
with other clinical trials staff working inside and outside NHS trusts.
The guidance has been developed as a result of significant additional
regulation of clinical trials and changes in practice in recent years.
The EU clinical trials directive of 2001 resulted in changes to UK law
that came into force in May 2004. Other changes include the Research
Governance Framework for Health and Social Care, changes in the Central
Office for Research Ethics Committees and developments in medicines management.
“A lot of trusts are likely to be already working to the standards
suggested in the guidance,” said Mr Gilroy. He added: “For
those that are not, they can identify the changes in practice that will
be needed.” He
recommended that all pharmacy staff, not just those involved in the clinical
trials area, should become familiar with the guidance. He also suggested
that external sponsors of trials (eg, drug companies) should read it,
so that they know what standards NHS trusts will be working to.
The guidance was due to be formally launched during a meeting at the
Society on 19 May. A full version is available from the practice
section of the Society’s website. A slightly
abridged version is available in this issue of The Journal (pp629–30 PDF (55K)). |
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