SOURCE: Cutting Edge Information

Cutting Edge Information

August 08, 2016 07:43 ET

78% of Pharma Medical Affairs Teams Continue to Support Post-Marketing Studies

Companies leverage clinical teams' expertise to supplement gaps in medical affairs capabilities.

RESEARCH TRIANGLE PARK, NC--(Marketwired - August 08, 2016) - New data published by Cutting Edge Information reveal that the majority of surveyed pharmaceutical companies continue to support post-marketing studies through their medical affairs teams.

However, medical affairs' ownership does not preclude the involvement of other teams, such as clinical operations and market access functions. In fact, the data show that 17% of companies' clinical development/R&D teams control post-marketing studies , while only 6% of companies run Phase 4 studies through the market access function.

The newly published data are found in the study, Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes. The data also 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.

"Having multiple groups' insights can be beneficial but also problematic," said Natalie DeMasi, research team leader at Cutting Edge Information. "Formalizing each team's post-marketing responsibility level may help companies become more efficient and eliminate confusion."

Depending on a drug company's goals, owning the post-marketing studies process may fall to groups other than medical affairs. For example, one Top 10 drug company recently transitioned its post-marketing studies from medical affairs ownership to clinical development. Prior to the transition, the head of global epidemiology estimated that her company had missed several opportunities to conduct efficient post-marketing studies because medical affairs teams did not know about the clinical development strategy as quickly as anticipated. Positioning its clinical development team at the forefront of the post-marketing strategy ensured that this company's committees become aware of clinical findings faster.

Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, available at http://www.cuttingedgeinfo.com/research/medical-affairs/phase-iv-clinical-trials/, provides insight and best practices on post-marketing research ownership, resourcing and staffing post-marketing studies. The report also includes trend analysis and metrics on interventional and observational studies, as well as data on the effectiveness of study outcomes due to early planning. Study findings will help post-marketing study managers:

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

To learn more about Cutting Edge Information and its post-marketing study report, please visit http://cuttingedgeinfo.com/.

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