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Connor: 2007 Will Be Tipping Point for EDC



Explosive growth in electronic data capture (EDC) adoption this year helps qualify the technology as the “most disruptive…since the introduction of the personal computer itself,” according to the just-released EDC Spending Forecast and Analysis by Christopher Connor, senior research analyst with Framingham, MA-based Health Industry Insights. Clinical research organizations (CROs) will have a “significant impact on the market” in 2007, when the EDC adoption growth rate accelerates from 6.5 percent to 13.3 percent.

By year end, nearly half of all new Phase I-III studies will use EDC, the report predicts. But pricing in large Phase II and Phase III studies will begin to take a major dip as a result of enterprise licensing, EDC subscription delivery models, and “fierce competition enabled by data interchange standards.”

In 2008, the growth rate of EDC adoption in the Phase II and III segments will outpace that of EDC spending, the report concludes. Conversely, in 2009, spending growth will outpace adoption growth in the Phase I market segment.

Based on Connor’s forecast, overall spending on EDC will rise at a 14.7 percent compound annual growth rate and total more than $3.1 billion for 2006-2011. Average time to deploy an EDC study will fall by more than half over the same period.

One of the key factors driving EDC adoption and spending is an “acute” need to improve efficiencies, and thus the bottom line, of pharmaceutical companies. Other high-impact economic forces include EDC’s ability to improve regulatory confidence and provide centralized oversight on global studies, the report states. Conversely, the number of new clinical trials will be limited by trial-related costs and manpower issues as well as adaptive studies. By 2011, adaptive design alone could reduce new trial volume by as much as 15 percent annually.

Rapid drug development initiatives, such as Wyeth’s “Learn and Confirm” process, have exposed the limitations of the traditional phased approach but also the necessity of high-quality clinical data that is “best provided by EDC,” the report states.

In the area of technology and service developments, the report names subscription pricing and the potential for increased spending on large-scale, post-approval studies as the top accelerating market forces. On the flipside are global help desks “supporting technically naïve users speaking different languages in different cultures, and in different time zones.” Labor supply will be a major challenge for EDC vendors in terms of recruiting and retaining highly skilled customer service personnel, demonstrating domain expertise, and simultaneously initiating study sites across the globe.

Positive market characteristics, aside from the impact of CROs, include a flattening learning curve for EDC and growing interconnection between “therapeutic islands” with the reuse of data elements via global libraries, according to Connor’s report.

EDC buyers are advised to “fully invest in EDC” -- including requisite cultural and process reengineering and the cost of support staff services provided by vendors -- and to seek out vendors that can “provide a common platform to integrate multiple sources of clinical data.”

In addition to investing in appropriate staff support, Health Industry Insights instructs EDC vendors to “increase the reliability of their hosted services” as well as the flexibility of their solutions for a growing range of users. Also on the vendors’ to-do list: increase data security, lower per-study pricing, and make self-service toolkits available “to eliminate the need for change orders.”

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