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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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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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