Companies are poised to speed up investments in electronic data capture.
Drug makers are finally putting their money where their mouths are with electronic data capture (EDC)--the technology that is supposed to drive clinical trials into the digital age.
Although companies have been increasing their EDC investments by about 6.5 percent a year, they're about to shift into high gear, with tech spending set to accelerate 13.3 percent this year and climb to 14.7 percent per year through at least 2011.
Consulting firm Health Industry Insights, which compiled the data for the forecast, reported that total investments in EDC would exceed $3.1 billion between 2006 and 2011.
EDC systems allow investigators to report study data electronically--and share it more quickly with fellow sites. The promise is faster trial times (and therefore lower costs) and eventually the ability to integrate those systems with other databases like electronic health records and clinical-trial recruitment programs.
"Companies started to realize that they were in big trouble in terms of their profits," said Chris Connor, a senior research analyst with Health Industry Insights. "EDC represented more than just technology. EDC is one of those technologies...that becomes a catalyst for change."
By the end of the year, about 45 percent of clinical trials will be initiated using EDC, the report noted, and the average time to complete those trials is expected to be cut in half.
While many drug companies had been test-driving EDC models over the past four years, full implementation has occurred only in fits and starts. In addition to the high price of the systems, drug makers had to contend with a large number of small vendors--each with its own electronic system that was incompatible with any other. That meant a constant retraining of investigators and duplicated data.
"This was a market of pilot studies--and each pilot study was autonomous," Connor said. "Every one became a one-off, and it was very hard to get economies of scale. It was harder than they expected it to be."
But companies that persisted began to see benefits. Connor noted that drug makers like Eli Lilly, GlaxoSmithKline, and Pfizer were among the first to integrate EDC companywide.
Another sign of industry change: More money is being invested in EDC for smaller, shorter phase I trials. Spending there is expected to increase a whopping 32.5 percent per year through 2011, compared to 4.9 percent for phase 3 studies.
"The low-hanging fruit--the ones that were 'worth' the investment--were the large, multi-site phase II and phase III studies," Connor said. "But EDC is starting to become a basic technology now."
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma
January 17th 2025Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.