New directive for clinical research will have huge impact
on pharmacists
SIGNIFICANT changes to the way clinical trials are
conducted will come in the wake of the publication of the European directive
on clinical trials (2001/20/EEC).
There will be a significant increase in responsibility
for pharmacists working in the industry. This will be seen in manufacture
and release of test products, comparators and placebos for commercial
trials; in developing appropriate validated analytical procedures; in
co-ordinating regulatory information from companies and trial collaborators;
and in guaranteeing the quality of other trial supplies originating from
non-European Union countries.
Pharmacists in hospitals will require more specialist
equipment and environmental facilities, and dedicated staff to support
clinical trials, both commercially based and in clinical research. Regulatory
agencies will experience an increased workload, with inspection requirements
and shorter time-scales when dealing with clinical trial applications.
Ultimately, community pharmacists will need to be
informed of the performance, both in terms of efficacy and adverse events,
of any new products that they may dispense. Table 1 summarises 12 key
changes that will be brought about when the directive is implemented in
2004.
Perhaps the biggest challenge — and opportunity
— is to find and train sufficient qualified persons who will be needed
to attest the quality of all manufactured clinical trial supplies. The
directive says that “appropriately qualified personnel” should be involved
in conducting clinical trials, but the Institute of Clinical Research
says that no formal qualification exists.
However, clinical researchers in the pharmaceutical
industry will be able to study for new qualifications under a plan developed
by the ICR and the Association of the British Pharmaceutical Industry.
The ICR is to develop a set of modular units for
clinical research associates working with clinical trial study sites,
defining best practice and the criteria by which full competence in the
role can be demonstrated. These standards will be used as the basis for
a recognised qualification in due course.
The Joint Pharmaceutical Analysis Group presented
a symposium last month that explored the implications of the directive
for production and the use of clinical trials materials (see p26).
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