The Impact of the Web and Standards on Clinical Trials

Abstract

Since the inception of the Internet and the World Wide Web in adopted at sites and the use of various forms of technology. The the 1970s and 80s, the world has changed. Websites and e-mail survey results indicated that only 30% of trials run by pharmaceuhave become central to the way enterprises conduct their business; tical companies and 11% of those run by contract research orindeed, it would be hard to imagine any company not using ganisations (CROs) were employing electronic data capture electronic communications to run their day-to-day operations. (EDC) technology in 2004, even though the development of the VeriSign Inc. reported that, as a conservative estimate, there are first systems used for the capture of clinical trial data appeared 2.25 billion e-mails sent every day,[1] while a 2003 report from the around 20 years ago (see figure 1).[5-7] While these early systems International Data Corporation put the number at approximately were not web systems, the CDISC research from 2004 indicates 31 billion.[2] Companies like Amazon and Google exist only that 66% of trials were still using paper. It is evident that the because of the web. Amazon.com was formed in 1994, launched clinical trials world has not embraced technology to its fullest its first international site in October 1998 and in 2005 made a gross extent; however, as shown in the figure for electronic case report profit of $US2039 million on a turnover of $US8490 million.[3] form (eCRF) and electronic patient reported outcome (ePRO) Google, founded in 1998, was handling 4.1 billion searches in July systems, adoption is on the rise. 2007 from within the US alone.[4] These two companies illustrate the impact of the web and the underlying technology that allows 1. Why Not in Clinical Trials? the web to function, technology that must surely be a consideration for the future of clinical trials. The financial sector is often used as an example of the successUnsurprisingly, powering websites such as Amazon and Googful adoption of technology, with Automated Teller Machines le are standards. The standards that are now maintained by the (ATMs) cited as an example of successful implementation of both World Wide Web Consortium (W3C) – the Hyper Text Protocol standards and technology. As we started to move more freely Standard (HTTP), the Transmission Control Protocol (TCP) and around the world, the financial services market recognised the the Internet Protocol (IP) – sit at the very core of the web and came advantages of being able to put a bank card into an ATM anywhere 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 industrial revolution. However, all this activity and technological innovation has, in some ways, not been fully utilised within the clinical trials industry, where the adoption of technology has been markedly slow. In 2002, 2003 and, most recently, in 2004, the Clinical Data Interchange Standards Consortium (CDISC) conducted surveys to ascertain the uptake of technology within clinical trials. In particular, the 2004 survey tried to establish how far technology had been 30