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Shortening the cycle of clinical trials

“The average cost of new drug development for a blockbuster drug is more than $900 million. The average clinical trial period, which includes all phases for a major drug, is approximately eight years, with a cost of up to $400 million,” says Tab Edwards, HP Market Development Consultant. “Pharma companies are looking for any opportunity to reduce the clinical trials stage of development so they can get their products on the shelves and begin recouping those costs.”

Typically, doctors participating in clinical trials collect data manually using paper Case Report Forms. For any given trial, there could be 1,000 trial sites or more, each going through the process of dual data entry. The trial sponsor cannot close out the trial until each database is “locked,” which can take weeks, with significant timing differentials between sites.

Electronic data capture

To combat these issues, companies have adopted electronic data capture (EDC) solutions to speed the time between data collection and availability. One EDC solution comprises outfitting physicians with laptop PCs with electronic forms and access to Web-based applications. Though there has been rapid adoption, many physicians find this EDC implementation challenging and feel it is unnatural to their preferred way of evaluating patients.

Using a Digital Pen and Paper-based solution, physicians can “manually” record information on specially designed forms. Once they dock their digital pen into a docking station, all the data is available immediately. Investigators don’t have to spend much time learning new processes or technology or make significant adjustments in their normal visit procedures.

In addition to the Digital Pen and Paper-based solution, which is provided as a hosted, Software as a Service (SaaS) application designed for clinical trials, HP also provides consulting and integration services including a pre-trial readiness assessment as well as infrastructure and help desk support.

“Conducting a clinical trial is a major investment for pharma companies when you take into account what’s involved—facilities, infrastructure, contract research organizations, technology, patients, physicians, and other professionals,” notes Edwards. “So shortening that cycle, even by a week, can have a huge impact on the sponsor’s bottom line.”

To learn more call 1-877-258-6162 and reference code 15.

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