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
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
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.