Drug firms face tech hurdles in clinical trials

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By Julekha Dash

(IDG) -- Using technology to speed up clinical trials is gaining steam in the pharmaceutical industry, but companies still face several obstacles that may keep them from reaching the full potential of the new tools.

For instance, Yamanouchi Pharmaceutical Co. is struggling with a lack of data standards for trials conducted globally, said Carl Allison, director of clinical data management at the Tokyo-based firm.

"At the end of the day, you want a clean database," Allison said last week at a pharmaceutical technology conference here sponsored by London-based SMi Group. During the next year and a half, Yamanouchi plans to standardize how it defines patient data, as well as establish Oracle Clinical as its remote database management system across its global sites, he said.

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The pharmaceutical industry began looking into technology to speed up clinical trials two years ago but just started launching full-scale projects this year, said Mark Anderson, CEO of Arc Consulting Group Inc. in Irving, Texas.

The technology itself isn't the biggest obstacle, said Pam de Rivaz, director of strategy and change management at London-based pharmaceutical company GlaxoSmithKline PLC. Companies "spend a lot of energy selecting a tool and not a lot of thought on actually re-engineering their processes," she said.

GlaxoSmithKline will spend the next year or two establishing a process re-engineering initiative to help employees get used to changes in their work, de Rivaz said.

Another problem is that the IT infrastructure in some countries is too unreliable to implement such systems, said Stephane Rouault, European head of data management at Strasbourg, France-based pharmaceutical and life sciences firm Aventis SA. Aventis has piloted electronic data management trials but plans to wait until the technology matures before using it on a more widespread basis, he said.

New York-based Pfizer Inc. recently completed two clinical trials in which patients with migraines or overactive bladders recorded drug responses in an electronic patient diary, which was then loaded onto an Oracle database, according to Stuart Pearce, a team leader for electronic data capture at Pfizer.

Pearce said that overall, patients found the technology easier to use than filling in information on lengthy forms, because the screen contained just four buttons.