| We all know that staff involved in clinical research must be appropriately trained
– after all it is a mandatory requirement under the GCP guidelines. However, how
many staff within clinical study teams are really appropriately trained to work in
their therapeutic area which is their field of research specialisation? How many are
confident: that they have the background understanding to ensure that protocol
requirements are met; that selection criteria are being properly implemented; and
that the data collected are consistent? How many understand the significance of
adverse events in the context of the disease, its treatment and the therapeutic
profile of study drug(s)? Not many.
Recently a colleague bemoaned the
fact that some well qualified monitors
– medical doctors, in this case – were
so focused on the ‘tick box mentality’,
rather than the significance of data, that
they failed to query a potassium level of
16. The patient would have been dead.
From a different point of view, how many
study team leaders are confident that
their staff can inform and motivate
investigators, have balanced discussions
on the study and its clinical context,
while running the clinical programme
effectively with a strong therapy
knowledge base? Even fewer, I
would suggest.
THE BACKGROUND
Interestingly, the pharmaceutical industry
spends vast amounts of money seeking to
convince the prescribing fraternity that
their drug development programmes,
products, services and scientific staff are
of the highest calibre, are reliable and
ethical. Relative to this, the investment
in ensuring that clinical research staff
are appropriately educated and informed
in their disease area of investigation is
woefully small. Why is this the case? |
