Roughly 82% of Pharma Companies Conduct Observational Studies Each Year

RESEARCH TRIANGLE PARK, NC--(Marketwired - April 27, 2017) - The majority (82%) of surveyed drug manufacturers reported conducting -- or planning to conduct -- observational studies last year, which has become more common, according to a study by business intelligence research company Cutting Edge Information.

The data published in Post-marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes show that from 2014 to 2016, the frequency of surveyed firms conducting observational studies remained relative flat -- only a slight decrease from 84% to 82%. Compared to interventional trials, Phase 4 observational studies require less human and spending resources.

Observational studies are those in which investigators are not required to influence or impact study participants. Instead, investigators look for the natural relationships between factors impacting the study population and specific outcomes. Observational trials allow pharmaceutical companies to gather valuable, descriptive real-world data. Companies use these post-marketing studies to gather information related to product usage patterns, cost-effectiveness and long-term effectiveness.

"Because these trials don't have the complex elements related to traditional clinical trials or interventional studies, post-marketing teams can focus less time on investigator training," said Natalie DeMasi, research team leader at Cutting Edge Information. "Life science firms find observational studies particularly accessible compared to more involved experimental studies because the training timeline is shorter."

Observational studies can look to both prospective and retrospective data to inform findings. Even prospective studies, which follow patients through a predetermined period of time, can call on retrospective data. In fact, the majority (60%) of surveyed life science companies used or included retrospective data in their Phase 4 observational studies.

Despite their advantages, observational trials have drawbacks. Real-world data collected in observational studies have higher external validity but will probably not yield data with the internal validity that interventional studies have. Additionally, observational studies can be more complicated in terms of protocols and statistical analyses. Life science teams must weigh all these different considerations carefully when planning their post-marketing studies.

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 download the brochure at:

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Contact Information:

Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information

Phase 4, retrospective study post-marketing study, observational study