SOURCE: Cutting Edge Information

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May 30, 2017 20:09 ET

78% of Life Science Teams Conducting Phase 4 Research Turn to Medical Affairs Teams for Post-Marketing Activities

RESEARCH TRIANGLE PARK, NC--(Marketwired - May 30, 2017) - Approximately 78% of surveyed life science teams with dedicated post-marketing groups align them under medical affairs, according to new research by business intelligence provider Cutting Edge Information.

The newly published data, found in the study, Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, revealed that the next closest function -- clinical development -- oversees dedicated post-marketing groups' activities at only 17% of surveyed companies.

Additional data show that all surveyed global pharmaceutical teams involve their medical affairs functions in strategic post-marketing study planning. Furthermore, medical affairs functions at 86% of surveyed US-level teams contribute to the post-marketing study planning process.

The study also found that medical affairs functions play a key role in late-stage research, even among companies without dedicated post-marketing groups. Among all companies surveyed, medical affairs functions overwhelmingly handle the planning aspect of post-marketing research. Nearly all surveyed country-level teams (92%) outside the U.S. expect medical affairs functions to assist with post-marketing study development. To a lesser degree, medical affairs groups may also be involved in study execution (68%).

Only four percent of surveyed companies do not involve medical affairs at all when conducting post-marketing studies.

"Despite the prevalence of medical affairs involvement, post-marketing planning is not solely their responsibility," said Natalie DeMasi, research team leader at Cutting Edge Information. "When executing their post-marketing studies, many life science companies involve additional groups in their strategic planning processes."

The study found that overall, companies rely heavily on medical and clinical expertise. Over half (62%) of surveyed companies also involve their clinical development and operations teams. To a lesser extent, companies may also rely on compliance (73%), regulatory (63%), and legal (52%) teams to assist with Phase 4 study execution.

Additional groups that many surveyed life science companies involve in post-marketing activities include market access (60%) and business development (41%). Still, other companies leverage the expertise of additional, dedicated Phase 4 groups. For example, at one surveyed Top 50 company, a dedicated group supports the global-level Phase 4 planning and execution activities.

Post-marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, available at https://cuttingedgeinfo.com/product/phase-4-clinical-trials/, 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 download the brochure at: https://cuttingedgeinfo.com/preview/phase-four-clinical-trials/.

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