Report on best practices in Phase IV clinical trials

Phase IV clinical research is growing rapidly, meaning expanding budgets for post-marketing research studies. And more of that work is being done by third parties and specialized vendors, according to a new study from Cutting Edge Information.

“Companies that outsource a majority of their Phase IV trial budgets derive a strategic advantage by outsourcing.”

"Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management" found that registries and observational studies have the highest percentage, on average, of their budget allocated for outsourcing - 60 percent. The next highest outsourced budget percentage is for large simple safety trials - 48 percent.

"For many companies, the infrastructure needed to conduct Phase IV studies in-house is sometimes too costly to justify," said David Richardson, research team leader at Cutting Edge Information. "Companies that outsource a majority of their Phase IV trial budgets derive a strategic advantage by outsourcing."

Recent survey and interview works showed that 64 percent of US-based drug companies have the internal infrastructure needed to conduct Phase IV studies in-house, but only 44 percent of European-based firms have the internal capability and expertise they want. Companies without those capabilities outsource their Phase IV studies to clinical research organizations (CROs) and maintain smaller project management teams to manage vendors and oversee trials.

Not all companies have opted to outsource their Phase IV research, however. Some companies have maintained large internal resources to manage their Phase IV studies, often within the medical affairs organization, according to the study. These companies typically have a continuous need for Phase IV resources and argue that the smaller and often specific nature of post-marketing studies makes handling them internally more appropriate and even cost-effective for clinical trial budgets.

"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, patients-per-site, patients-per-investigator and other key metrics for five types of Phase IV studies. It includes metrics covering the U.S., Europe and global operations as well as seven therapeutic areas.

The study supports medical affairs and scientific communication decision-making on key goals identified by benchmark partners including:

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

Source Cutting Edge Information