Study Finds Growing Market for Electronic Clinical Trials

The size of the market for eclinical trials was $210 million in 2004 and will increase to $357.4 million in 2011, according to a new report published by consulting firm Frost & Sullivan.

Projections of this sort often deserve a skeptical eye, but “The market figures are obtained by directly touching base with all the key industry participants who are offering electronic trial technologies … Only electronic trial software license and service revenues are considered for calculating the market figures,” said Raghavendra Chitta, a research analyst with Frost & Sullivan.

But that’s a lot of money for pharma companies to lay out, and those responsible for getting senior management to buy into the eclinical world have their work cut out for them in demonstrating that there is good return on investment (ROI) for this technology. “ROI is a major hurdle for the eclinical trial vendors with regard to moving their technology beyond the pilot stage to an enterprise-wide implementation,” said Chitta. “Often, the eclinical trial teams end up choosing wrong parameters, which might result in an unimpressive ROI for the top management.”

Facing Resistance

Institutional resistance remains on other levels as well. “Most of the large pharmaceutical companies have developed their own proprietary computer systems and data standards, making integration of those systems with the new eclinical trials technologies difficult to achieve,” Chitta said.

Moreover, individual researchers working for pharmaceutical firms often remain wedded to traditional paper trial records. “Biologists are traditionally wary of technology,” said Chitta, noting that “most of the tools tend to be a little complicated and not very user friendly,” which makes biologists turn back to traditional methods when even minor problems arise. Many senior researchers and scientists also received their training before the era of powerful modern computers and are not used to using these tools, he added.

Moving to electronic processes would also mean a realignment of the various roles and responsibilities of research scientists. This would result in “some of the researchers having to surrender their traditional fiefdoms, which might not be too welcome,” Chitta said. There is no easy way to change researchers’ long-established preferences, but developing “simple user-friendly tools” and spending more time on user training could help, he suggested.

Proving ROI

To bring everyone on board with eclinical trials, vendors and IT managers need to develop models proving the technology’s worth. More explicit technological standards from the FDA would help, Chitta said. “Clear definition of standards goes a long way in driving the adoption of these technologies. The FDA’s recent announcement in its Critical Path Initiative that it is increasingly looking at electronic submissions as a way ahead to cut down the current approval times is generating acceptance among even the naysayers in the drug discovery industry,” he noted. Regulatory acceptance of standards developed by the Clinical Data Interchange Standards Consortium (CDISC) “is lowering the technological barriers and paving [the] way for greater integration of data standards,” which is driving adoption, he added.

Management sometimes needs to be persuaded that putting clinical trial information into an electronic format actually increases its value, making it easier to put it together with drug safety information and other decision making data. “Successful cases are where companies have realized the importance of integration and have made all efforts to make their tools integrate seamlessly with legacy systems,” Chitta said. — Martin Gidron