Data volumes lead to paper-free trials?

The volume of clinical trial data is finally pushing the pharmaceutical industry away from costly and inefficient paper-based information systems. Industry commentators from KPMG believe that the case for transferring over to electronic systems is becoming more compelling.

Two-thirds of clinical trials data is still tabulated on paper, which Stephen Oxley, European Head of Pharmaceuticals at KPMG, believes is due to: 'a long-held fear that converting clinical trials data to an electronic format will compromise a company's intellectual property rights.

'However, the cost of persisting with paper-based systems cannot be dismissed lightly,' he added. 'In the US, it can cost as little as $4.50 per page of data submitted electronically to the FDA, as opposed to $23 for paper-based submissions. What's more, it is also claimed that drug companies can save as much as $2.5m every day that a large-scale clinical trial is shortened.'

There are indications that the industry's suspicion of electronic networks has begun to erode. Figures estimate that the industry will spend $27bn on information technology in 2005, compared with $10bn in 2000. Within that, spending on storage servers and storage-management software is the fastest-growing category of IT investment.

The US will take the lead in terms of this increased IT spend. Allegations that drug companies failed to disclose negative data on clinical trials has led to Congressional demands for the creation of a national registry of clinical trials data.

Oxley continues: 'While every measure must be taken to secure data, let's hope the industry fully embraces the electronic storage possibilities.'