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International Clinical Trials
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I believe that, in many parts of life, technology is reaching the point where it is starting to become truly invisible. It is fading into the background of the main activities which it is there to facilitate, and it is at that point that the real value of the technology can be extracted. For instance, my car, through no particular effort of my own, routes me around traffic jams as I travel from place to place. My washing machine calculates how full it is and adjusts the cleaning time and programmes accordingly. My dishwasher knows how long to run wash programmes for (although I have no idea how). And my computer knows how I meant to spell things, and suggests searches I might use to find what it believes I am looking for. For EDC, I contend that it is the same fading of technology into the background that will bring about the next major advances in the day-to-day management of clinical trials. This revolution is already with us, offering the opportunity to extract significantly more value from EDC than I believe we presently demand. In this article, I attempt to explain why I believe that we have the potential to extract much more from EDC today, as well as a personal perspective of the development of the technology as I have experienced it over the last 20 years.
A PERSONAL HISTORY OF EDC
Twenty years ago, when I had just joined Pfizer, EDC was in its infancy. We had decided to run EDC on the Spanish part of a protocol which I was running in our Phase III programme. The system was completely customised – written from scratch on Apple Macs. Back then, our concept of the value proposition of an ideal EDC system was very broad. We were looking for a system which would:
- Reduce source data verification (which was just getting into the swing of 100 per cent checking) by encouraging investigators to put the data straight into the computer, thereby bypassing paper
- Clean the data as you went, using inbuilt error checking, whilst eliminating scribbled notes on the margins of paper, which might indicate SAEs, and are easy to overlook
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