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Bridging the Clinical Knowledge Gap

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?


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Jane Nathan is a Director of PharmaEd and PharmaEd Interactive. Jane’s background combines education and clinical research; both disciplines are combined in the medical education and multimedia functions of PharmaEd. Jane taught in higher education for five years in Biological and Health Sciences at the Polytechnics of Brighton and Central London. Thereafter she moved into clinical research at Glaxo and worked in a variety of therapy areas, in all clinical phases. Jane has worked in medical education for 14 years, and now heads PharmaEd, a specialist medical education agency.
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