SOURCE: Cutting Edge Information

November 14, 2007 11:28 ET

Phase 4 Clinical Trials Claim an Average of 14% of R&D Budgets, Study Says

RESEARCH TRIANGLE PARK, NC--(Marketwire - November 14, 2007) - Companies dedicate an average of 14% of their R&D budgets to Phase 4 clinical trials, according to a study released by industry intelligence leader Cutting Edge Information. The study, titled, "Mastering Phase IV Clinical Trials," is available at http://www.PostMarketingTrials.com.

The study compiles Phase 4 spending data from a survey of more than two dozen industry executives. More than half of responding companies spend between 10% and 20% of their overall R&D budgets on Phase 4, although individual responses range from 2% all the way up to 30%.

"Considering companies have typically dedicated the most resources to pre-market trials, especially Phase III, an average allocation of 14% in Phase IV is pretty significant," says Elio Evangelista, research team leader at Cutting Edge Information. "But spending in this area will only continue to increase as pharma reacts to pressure from FDA and as companies seek to establish reputations for their products."

According to the report, payer groups and regulators are both requiring more post-marketing data from drug companies. In fact, FDA has begun to insist that every new chemical entity (NCE) that comes to market undergo Phase 4 evaluation. To meet these demands, pharma companies are taking a more integrated approach to post-marketing trials -- they are no longer the exception, but the rule.

"Mastering Phase IV Clinical Trials" (http://www.PostMarketingTrials.com) also addresses clinical trial performance measurement. The report contains lists of profiled companies' target and actual performance measures. Among the metrics included in the report are:

* Cycle times, such as "time from first patient in to last patient out" and "time from database lock to statistical tables complete"

* Resource-based measures, including "patients per CRA"

* Efficiency or operational metrics, such as "data errors" and "patient retention rates"

To view a summary of "Mastering Phase IV Clinical Trials," visit http://www.PostMarketingTrials.com or contact Elio Evangelista at Elio_Evangelista@cuttingedgeinfo.com or 919-433-0214.

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