Guidance for clinical trials launched
Pharmacy clinical trial services practice guidance was launched at a meeting at the Royal Pharmaceutical Society on 19 May. The guidance has been jointly written by the Society and the Institute of Clinical Research.
When launching the guidance at a recent clinical trials meeting (see
p226), John Gilroy, chair of the Institute of Clinical Research Pharmacy
Subcommittee, recommended that it should be read by all pharmacy staff.
He highlighted the need for designated pharmacy staff to look after all
aspects of clinical trials in dedicated facilities and stressed the importance
of developing good working relationships with staff involved in trials
both inside and outside the NHS. Ensuring proper management systems,
and suitable archiving practices are also key recommendations of the
report, he added.
Mr Gilroy pointed out that the guidance has been developed as a result
of the significant amount of new regulation affecting clinical trials,
such as the EU clinical trials directive that came into force in May
last year, changes to 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,” he
added.
An abridged version of the guidance (PDF 55K)
is available from The
Pharmaceutical Journal (2005;pp629–30), with the full version
available as a PDF file
(930K).
National Pharmacy Clinical Trials Network
The first meeting of the National Pharmacy Clinical Trials Network
was held recently. Almost 50 delegates met in Birmingham on 27
April to discuss manufacturing in the NHS, Good Clinical Practice
inspections and commercial research.
Those interested in joining the network group should, in the first
instance, e-mail Mark Howells at mark.howells@burtonh-tr.wmids.nhs.uk to be provided with further details. |
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