The Impact of the Web and Standards on Clinical Trials
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COMMENTARY
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The Impact of the Web and Standards on Clinical Trials David Iberson-Hurst Assero Limited, Frome, England
adopted at sites and the use of various forms of technology. The survey results indicated that only 30% of trials run by pharmaceutical companies and 11% of those run by contract research organisations (CROs) were employing electronic data capture (EDC) technology in 2004, even though the development of the first systems used for the capture of clinical trial data appeared around 20 years ago (see figure 1).[5-7] While these early systems were not web systems, the CDISC research from 2004 indicates that 66% of trials were still using paper. It is evident that the clinical trials world has not embraced technology to its fullest extent; however, as shown in the figure for electronic case report form (eCRF) and electronic patient reported outcome (ePRO) systems, adoption is on the rise. 1. Why Not in Clinical Trials? The financial sector is often used as an example of the successful adoption of technology, with Automated Teller Machines (ATMs) cited as an example of successful implementation of both standards and technology. As we started to move more freely around the world, the financial services market recognised the advantages of being able to put a bank card into an ATM anywhere Total number of trials initiated (%)
Since the inception of the Internet and the World Wide Web in the 1970s and 80s, the world has changed. Websites and e-mail have become central to the way enterprises conduct their business; indeed, it would be hard to imagine any company not using electronic communications to run their day-to-day operations. VeriSign Inc. reported that, as a conservative estimate, there are 2.25 billion e-mails sent every day,[1] while a 2003 report from the International Data Corporation put the number at approximately 31 billion.[2] Companies like Amazon and Google exist only because of the web. Amazon.com was formed in 1994, launched its first international site in October 1998 and in 2005 made a gross profit of $US2039 million on a turnover of $US8490 million.[3] Google, founded in 1998, was handling 4.1 billion searches in July 2007 from within the US alone.[4] These two companies illustrate the impact of the web and the underlying technology that allows the web to function, technology that must surely be a consideration for the future of clinical trials. Unsurprisingly, powering websites such as Amazon and Google are standards. The standards that are now maintained by the World Wide Web Consortium (W3C) – the Hyper Text Protocol Standard (HTTP), the Transmission Control Protocol (TCP) and the Internet Protocol (IP) – sit at the very core of the web and came together in the early 1990s to form what we understand today as the Internet and the World Wide Web. Combined with the standards for e-mail, Post Office Protocol 3 (POP3) and Simple Mail Transfer Protocol (SMTP), the way these standards have revolutionised the world is comparable to the
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