Planning Phase 4 Studies: When (and Where) to Involve Medical Affairs Teams

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 15, 2017) - Global pharmaceutical businesses are the most likely to involve multiple functions in postmarketing, or Phase 4, study planning. A recent study of pharmaceutical companies found that among surveyed global teams, 100% reported involving medical affairs, compliance and legal functions in their Phase 4 strategy-building activities. Additionally, 88% of surveyed global teams involve market access, and 75% involve both marketing and regulatory functions in Phase 4 study plans.

The data in Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, published by business intelligence firm Cutting Edge Information, revealed that there were notable discrepancies in the functions that plan Phase 4 studies based on team geography. For instance, when planning postmarketing studies, surveyed teams in the US favor the expertise of medical affairs and clinical development functions. The data show that 86% of US teams involve their clinical functions during postmarketing study planning, compared to only 57% of surveyed global teams and 50% of ex-US country-level teams that do the same.

"Companies involve a mixture of medical affairs, clinical development and many other teams in their postmarketing activities," said Natalie DeMasi, research team leader at Cutting Edge Information. "Specific functions' level of strategic planning and execution responsibilities may differ based on many factors, such as each team's geographic alignment."

Country-level teams are most likely to involve their medical affairs function (92%) during Phase 4 study planning activities. Between 50% and 60% of these teams incorporate compliance, market access, regulatory or clinical development groups. However, very few country-level teams reported involving legal, business development or commercial teams to design their post marketing research.

Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, available at, provides insight and best practices on post-marketing research ownership, funding and staffing post-marketing studies. The report also includes trend analysis and metrics on interventional and observational studies, as well as the effectiveness of study outcomes due to early planning. The study's analysis helps Phase 4 teams:

  • Determine the best-fit post-marketing research alignment for global and regional-level teams.
  • Implement key recommendations for planning the number of studies per product.
  • Understand the latest trends concerning observational and interventional studies.
  • Identify post-marketing study team staffing trends.

To learn more about Cutting Edge Information's pharmaceutical industry research and its Phase 4 excellence report, visit

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Contact Information:

Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information

post-marketing, medical affairs