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the numbers in tables in the text, I agreed that describing the data is good but that this was different from merely repeating it. It is only relatively recently that the movement
known as ‘lean writing’ has come to be recognised and adopted by organisations. The goal of lean writing is to make the writing, reviewing and reading of regulatory documents more efficient by eliminating pointless repetition, excessive wordiness and a style more appropriate for novels than technical documents. Nevertheless, it has not been adopted everywhere and I often find myself in heated discussions trying to convince academics and clinical research scientists to adopt a leaner writing approach. It seems that, despite the obvious advantages of lean medical writing in terms of time and cost, not to mention readability, there is still a long struggle ahead before it is universally adopted. Clearly, as has been noted by many observers,
what would greatly facilitate the general adoption of lean medical writing techniques would be the proposal and acceptance of standard text. A standard structure has been adopted for clinical study reports in the ICH E3 guidelines in 1995, which defined how such reports should be organised. This greatly streamlined report preparation and writing as – finally – a definitive document structure was available and most groups happily followed it. Unfortunately, despite a number of attempts, no generally agreed text has ever been accepted. These failures were usually ascribed to the great variability of clinical research with a wide range of products and study designs in different disease indications. It was clear to many medical writers, however, that many parts of a clinical study report are similar, regardless of the test substance or population. Sections on demographic variables and baseline characteristics or treatment-emergent adverse events, for example, often describe similar kinds of data sets and would appear to be ideal for standardised text. I have always felt that it was not the inherent variability in clinical studies, but instead it was the reluctance of many authors to relinquish control over what is still considered a personal thing – writing style – to a ‘standard’. This is a common mistake in technical writing, where people use techniques and a style more appropriate for fiction than a scientific document. I have even heard some medical writers describe with pride a piece of writing as being ‘beautifully written’. This is wonderful for literature but hardly
appropriate for clinical documentation. Thus, large-scale attempts to create standardised text in the pharmaceutical industry have never been successfully adopted, even within organisations.
“Writers who might object to being forced to write a certain way, will find that a computer providing suggestions based on data might be much simpler to accept than rewriting everything from scratch.”
The true potential of AI Here is where I believe that the use of AI software for clinical documents can truly be augmented in a way that, so far, has not been achieved. In developing an AI tool for study report writing with the software programmers, Trilogy defines the rules that should be followed to interpret the data and creates standard text to be used, depending on the results. Why do I think that this time will be different and that there will be wide acceptance of such standard texts when they have often have failed in the past? It is because, rather than appearing as a document that will be seen by many as demanding compliance and submission, the standardised text will be suggested as almost an afterthought to a system designed to save the writer time and tedious effort. Writers who might object to being forced to write a certain way, will find that a computer providing suggestions based on data might be much simpler to accept than rewriting everything from scratch. The introduction and wide use of AI tools for medical writing will definitely lead to large savings in time and money – assistance and acceleration – in the process of preparing clinical documentation. Whether it will also lead to the wide adoption of standardised texts to make these documents clearer and easier to understand is, of course, impossible to predict with any certainty. However, my more than 30 years of experience in the field makes me think that using such a ‘back door’ approach might finally be the opportunity for the field to take its long overdue step of using standardised texts and true augmentation in clinical document writing. ●
www.trilogywriting.com Outsourcing in Clinical Trials Handbook | 7
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