Drug Companies Spend an Average $13,000 per Patient on Comparative Effectiveness Research in Phase IV

RESEARCH TRIANGLE PARK, NC--(Marketwire - Aug 9, 2011) - The cost of running a comparative effectiveness trial is $13,087 per patient during Phase IV, according to a study by Cutting Edge Information.

Comparative Effectiveness Research (CER) compares drugs, devices or other medical tests and procedures to determine the most effective outcomes for patient populations. Drug companies often use CER studies to compare their products head-to-head against competitors. The study found that CER studies make up the second largest portion of the average Phase IV development program, at 29%. Data generated from CER studies can prove invaluable. Favorable results from a registered Phase IV comparator trial is a powerful marketing and sales tool and can eventually alter disease treatment patterns.

Cutting Edge Information's study, "Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," found that in the U.S., CER studies typically cost drug companies $14,924 per patient. But companies that conduct these studies in Europe can see a substantial savings. According to the research, European CER studies run an average $9,873 per patient.

"Comparative effectiveness research studies are some of the more costly Phase IV trials that companies can invest in," said David Richardson, research team leader at Cutting Edge Information. "They can also prove risky for companies when their drugs don't compare favorably. However, the risks may be worth the gamble as product teams face reimbursement challenges by payers who are unwilling to cover more costly treatments for unclear patient benefit."

CER presents an opportunity for drug companies to prove that their products are not only more effective than their competitors, but could also prove better patient outcomes -- such as longer life spans -- and more cost-effective in the long run.

"Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management," available at http://www.cuttingedgeinfo.com/research/medical-affairs/phase-iv-clinical-trials/, contains per-patient cost benchmarks on comparative effectiveness studies, patients-per-site, patients-per-investigator and other key metrics for five types of Phase IV studies. It includes metrics covering the U.S. and Europe as well as major therapeutic areas.

The study supports decision-making on key issues identified by executive benchmark partners:

• Explore key Phase IV benchmarks by company size and geography.
• Build budgets based on concrete benchmarks that enable teams to hit goals and support all studies.
• Understand and designate clear roles for Phase IV management and activities.