SOURCE: Cutting Edge Information

Cutting Edge Information

November 29, 2016 08:17 ET

Phase 4 Pharmaceutical Studies Lean on Medical Affairs for Strategic Planning

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 29, 2016) - Medical affairs functions are an ideal candidate to head post-marketing study strategy, according to new research published by pharmaceutical business intelligence firm Cutting Edge Information.

Medical affairs teams have unique experience through external interactions with physicians, such as through medical science liaisons (MSLs) and medical information teams. Coupled with other medical affairs sub-functions interacting with consumers of all types, these teams are better positioned to anticipate products' needs post-launch. Not surprisingly, this high level of expertise empowers medical affairs to design post-marketing studies that fill knowledge gaps, collect valuable safety metrics and fulfill other late-stage strategic objectives.

The data in Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-WorldOutcomesfound that medical affairs is one of the most-involved teams in Phase 4 study development. Analysis showed that 75% of surveyed global Phased 4 teams reported that medical affairs functions remain a constant presence during post-marketing execution. At the country level, 71% of US teams involve medical affairs during Phase 4.

Furthermore, 93% of medical affairs pharma teams are involved in the strategic planning process for Phase 4 studies. However, slightly more than two-thirds (68%) of medical affairs groups take part in the study execution process. Compliance functions are also involved in almost three-fourths (73%) of strategic planning for post-marketing study activities, but only 36% of these groups participate in study execution.

"The biggest argument for giving medical affairs the lead in post-marketing research comes from clinical and medical affairs functions' respective priorities," said Natalie DeMasi, research team leader at Cutting Edge Information. "Medical affairs functions ramp up their activity levels as products approach the launch window, as opposed to research and development teams who typically prioritize the clinical research leading up to Phase 4 studies."

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 the effectiveness of study outcomes due to early planning. The study's analysis helps Phase 4 teams:

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

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

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