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| home > epc > winter 2002 > edc use in clinical trials: are we on the verge of a breakthrough? |
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European Pharmaceutical Contractor
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In this article we attend to important issues, vital to the successful widespread adoption of electronic data capture (EDC) in the pharmaceutical industry. Based on experiences gained both from a pharmaceutical company and vendor perspective, we look at the state of the industry. Tentative pilot trials undertaken by many pharmaceutical companies have shown many positive benefits, however, the problems that did occur typically prohibited the scale-up of EDC to more trials and more patients. By looking at current issues and trends we consider how successful systems will develop in the near future.
The world's largest pharmaceutical companies are currently making some bold statements. Many claim that they will be undertaking 90-100 per cent of their clinical trials using electronic data capture by 2005 and one or two claim this will be the case in 2003/2004. Clearly this is a high priority action that will require significant resource to meet these aggressive timelines, particularly as the current technology is not scaled up and services around five to 10 per cent of most companies' R&D pipeline. There are major drivers for this reasoning.
The clinical R&D industry is in turmoil. Companies spend 20 per cent of their total revenues on drug development and investors are now viewing this sceptically, especially as only one third of new drugs make a profit in the market. Surely there must be a better way. The potential revenues to be found in genomics are currently locked away as pharma companies struggle to process potential compounds through the R&D machine. Hence there is a need to develop more compounds using the same or less resources.
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