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THE REQUIREMENTS OF CLINICAL TRIAL DOCUMENTS
The preparation of original patient reported outcome (PRO), informed consent form (ICF) and other clinical trial questionnaires, forms and documents is universally acknowledged as a meticulous process, in which mistakes simply cannot be tolerated – inaccurate or poorly worded documents jeopardise the informed consent and wellbeing of the individuals taking part in the trials and, more fundamentally, have the potential to invalidate the results of the trial itself.
Aside from these obvious implications, the research data gathered by clinical trials must be scrutinised by an independent authority; any miscommunication incurred by the original trial documents is liable to render that part of the research data unusable.
FINANCIAL IMPLICATIONS
If we consider the implications that this has for the profit margins of companies undertaking such research, the importance of the faithful translation of precise documents at every stage of research becomes obvious. Put succinctly, if a portion of research data becomes unusable, a delay will almost certainly ensue.
Of course, delays erode profit margins in any business; within pharmaceutical organisations, however, their effects are magnified. Figures such as the $820 billion forecast for pharmaceutical sales in 2009 belie the sensitivity and exposure to loss that afflict those undertaking original research and development of products. Estimates for the cost of developing an innovative, approved drug vary wildly and are likely to have increased considerably in recent years, but they are frequently in excess of $1 billion (1,2). |
