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Letters to the Editor
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Clinical trials
Guidance ignores trials involving several drugs
From Mrs S. J. Buckham, MRPharmS
Clinical trial
guidance issued recently (PJ, 21 May, p601) fails to
help pharmacists who are trying to bring academic trials of drug “cocktails” into
line with the EU directive.
When the directive was published last year the Paediatric Oncology Pharmacists
(POP) Group identified that for just one paediatric leukaemia trial there
were, by EU definition, potentially 66 investigative medicinal products
(IMPs). All are unlicensed for the disease and age group, but are used
as part of trial therapy.
There is no funding body to cover the cost of drug treatment for trials
like the one above, since the trials are a collaborative agreement to
improve treatment of childhood cancer on the NHS.
As NHS contracts demand that we regularly change suppliers, we may have
to swap mid-trial to an alternative manufacturer; effectively a new IMP.
We therefore use standard stock and not a separate trial supply.
There are currently about 30 active paediatric oncology trials co-ordinated
by the UK Children’s Cancer Study Group (UKCCSG). To persuade children
to take medicines we may have to use several formulations for any drug
in the trial protocol — some unlicensed “specials”.
Even allowing for the few drugs that are fully licensed in this context,
this leaves us with vast numbers of potential IMPs. The requirement for
one set of stock for those “on trial” and one for those who
receive “non trial standard” therapy, rather than them being
randomised possibly to receive the investigative “cocktail”,
is an additional headache.
POP is wholeheartedly behind properly conducted clinical trials, but
the Royal Pharmaceutical Society has taken little account of the practicalities
of its guidance in this area. Even the Medicines and Healthcare products
Regulatory Agency failed to clarify the
IMP status of the chemotherapy we use when they were requested to do
so by ourselves and the UKCCSG.
Yet again children’s services are being penalised due to a history
of inadequate licensing of paediatric medicines. We need support from,
and consultation with the Society, rather than an unworkable guidance
that is clearly geared to a single investigational drug.
Jane Buckham
POP Group,
Sheffield Children’s Hospital
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The
Pharmaceutical Journal