RESEARCH TRIANGLE PARK, NC – Phase 4 clinical trials last 27.6% longer than companies plan, on average. Phase 4 clinical trials are also referred to as post-marketing studies because they are clinical research that takes place after pharmaceutical companies launch a new drug.

The results of a survey of more than two dozen industry executives show that drug companies plan for Phase 4 studies to take approximately 400 days, on average. However, survey data show that post-marketing trials take an average of 110 days longer than companies originally plan.

These data, along with a host of other data on Phase 4 trial resource allocation, performance measurement, and activities, are available in a new report, “Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy and Benchmarks” from Cutting Edge Information, a Research Triangle Park-based pharmaceutical business intelligence firm.

According to the report, the industry’s top 20 companies fare best in keeping the duration of their Phase 4 studies close to planned deadlines. Top 20 companies’ trials last only 89 days longer than expected, whereas, mid-sized companies’ trials extend 122 days beyond planned deadlines. Small companies’ studies take 111 more days than expected.

“It is to be expected that the largest companies – which have the most resources at their disposal – are able to get Phase 4 studies done faster than their smaller competitors,” says Jon Hess, research team leader at Cutting Edge Information and lead author of the report.

According to Hess, the 20 largest drug companies’ post-marketing studies last 440 days, on average. By contrast, mid-sized and small companies’ studies take 578 days and 475 days, respectively.

Hess says that “Phase IV Clinical Trials" 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 “Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy and Benchmarks,” visit www.PostMarketingTrials.com or contact Jon Hess at Jon_Hess@cuttingedgeinfo.com or 919-433-0211.

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