Fifty-One Percent of All US Post-Marketing Studies are Commitment Trials

RESEARCH TRIANGLE PARK, NC--(Marketwired - August 17, 2016) - A new study published by Cutting Edge Information found that on average, just over half of all US studies are commitment studies as opposed to just 11% of other country-level teams' studies. This trend is likely due to the increasing number of products that receive expedited approval in the US contingent on future post-marketing studies. From a global standpoint, 32% of post-marketing studies are commitment trials.

There are notable differences in the percentage of post-marketing studies that demonstrate cost-effectiveness. On average, one-tenth of global teams' Phase 4 studies have a primary goal of collecting health economics data, while 16% and 4% of country-level and US teams do, respectively. Previous research conducted by Cutting Edge Information found that HEOR data is far more critical in the EU than in the US, further supporting this data.

HEOR data are still important in the US, according to the new study, titled Post-marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes. The report's analysis may indicate that cost-effectiveness studies in the United States may be conducted more at the global level than by US teams. Alternatively, HEOR studies may be conducted by other US groups, such as market access.

"Different regions may have different treatment practices, and patient populations vary based on subpopulation geographies," said Natalie DeMasi, research team leader at Cutting Edge Information. "Goals will also vary based on the product's lifecycle, competition, and payer needs." However, post-marketing studies at the regional level will help companies gather local data critical for understanding regional prescribing patterns, patient adherence, and potential marketing extensions."

Post-marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, available at, provides strategic insights and key performance metrics on post-marketing research ownership, spending and staffing levels, as well as trend analysis. Data are broken down for interventional and observational studies and the report outlines the effectiveness of study outcomes due to early planning. Report highlights include:

  • Best practices for determining the best-fit post-marketing alignment for global and regional-level teams.
  • Methods for identifying post-marketing study team staffing trends.
  • Key recommendations for planning the number of Phase 4 studies per product.
  • Trend analysis concerning observational and interventional studies.

To learn more about Cutting Edge Information and post-marketing study management, please visit

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Contact Information:

Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information

Phase 4 Study Objectives