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E-Source: It's Coming, Experts Say


The CDISC figure includes the relatively painless "ePRO" trials, or electronically patient reported outcomes, which may involve little more than touch-tone telephones. Even so, there was a fair amount of negative opinion about ePRO technologies, especially from clinical sites that need to train patients on how to use hand-held devices. Said Iberson-Hurst: "Maybe the experience with the technology is not all we should be aiming for."

Paradoxically, Iberson-Hurst noted that while two-thirds of the industry is stuck in the 1960s, a minority is forging far ahead into "e-source" - trials that dispense with paper. "E-source is very much with us," he said. The bad news is that there is nothing close to regulatory clarity about e-source under 21 CFR Part 11.

As Iberson-Hurst explained, "An investigator who captures that data is obliged to maintain the source data, prevent its destruction, and allow access to inspectors. If we have e-source data, can they retain it? What is the meaning of the word 'retain'? How can they prevent destruction, given they have no access to what is being retained? The debate is going on. Vendors claim they are taking on investigator functions. But there is no mechanism under the law for that."

Given his self-deprecatory tone, it's clear Iberson-Hurst has been privately thrashed by the e-diary community for daring to identify ambiguities in the regulations. But the FDA is said to be working on a nonbinding "guidance" document for e-source, which could be published as soon as this summer. Although there is plenty of good news about patient diaries (see "Abandon Paper! Use a PDA!," June 2005 BioïIT World, page 48), such uncertainty could allow ambivalent sponsors to continue using paper until the dust settles.

Featured speaker Sylva Collins, vice president of advanced clinical systems at Novartis, presented her impossible-to-match metrics from EDC. In a sign of the shifting jargon, she referred to electronic case report forms (CRFs), which are basically computer screens into which paper-based clinical data are entered.

In 2001 alone, Novartis spent $17 million just printing paper CRFs. The company is now locking databases in less than a week and recording just four queries per 1,000 data points; it used to take as long a year to lock some databases, partly because of 51 queries per 1,000 data points. Collins expressed little patience for those who wonder why pharma builds software: "If you're in the modern drug development business, you're in the software development business. Get used to it."

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