The US is now demanding compliance with standards protecting privacy in clinical trials, warns Angus Kidman.

Published in The Bulletin, August 13 2002

In the late 1990s, IT managers in Australia were hit with a triple-whammy of updates: providing internet access for staff, ensuring that the Y2K problem didn't kill their systems, and making accounting software GST-compliant.

But there's no time for a breather in the growing fields of biotechnology and ­biomedicine. An obscure US regulation known as 21CFR Part 11 is the next item on the upgrade agenda.

Introduced by the US Food and Drugs Administration in 1997, the regulation allows companies running clinical trials to keep all documentation, including patient consent forms and signatures, in electronic rather than paper format. In return, they must follow a ­stringent set of rules to make sure confidential data isn't compromised.

While companies aren't obligated to take up electronic submission, few can afford the cost and complications of old-fashioned paper submissions. The regulation also affects local providers, since FDA-sanctioned trials are essential to access the huge US market.

Caroline Kovacs, general manager of IBM's life sciences division, describes the ­little-known rule as the Y2K problem of the pharmaceuticals industry. "It's going to be a huge challenge," she says. But the potential rewards are also huge. The biotechnology business overall has tripled in size in the US since 1992 and the market capitalisation of biotech companies has topped $US224bn ($415bn), according to the Biotechnology Industry Organisation.

In response to industry pressure, the FDA is yet to force companies to fully comply with 21CFR, but those that don't must be able to show that they have a plan which will eventually lead them to be compliant. There are tough requirements relating to audit trails and password security, which in turn have led to the emergence of specialised (and high-priced) consultants and software to help comply with the ruling.

Companies must also plan on IT systems for the long haul. The average time-to-market of a new drug is now estimated at 15 years. Whatever the difficulties, it seems there's no turning back from the electronic path. "Biology and computing have become, in a way that was never the case before, inextricably ­connected," says Kovacs.