SOURCE: Cutting Edge Information

Cutting Edge Information

June 28, 2016 08:17 ET

61% of Interventional Studies Are Traditional Randomized Control Trails

New Study Provides Metrics on Phase 4 and Post-Marketing Study Management

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 28, 2016) - A new study published by Cutting Edge Information discovered that 61% of interventional studies are traditional randomized control trials (RCTs). However, almost a quarter (23%) are large simple trials sponsored by surveyed teams, indicating that industry may have a growing focus on specific clinical endpoints that require a large patient population to detect.

Surprisingly, pragmatic RCTs make up only an average of 9% of surveyed teams' interventional studies, although these are predicted to increase in the future. There is also the possibility that aggregated n-of-1 trials may become more useful for studying chronic, rare disease, even though they currently average only 1% of surveyed teams' interventional studies. Crossover studies are responsible for the remaining 6% of surveyed teams' interventional studies.

According to the study, Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, traditional RCTs occur when patients are randomized into two different study groups: a control group and a group that receives the intervention. Most of the time, these studies are double-blinded and require large sample sizes and narrow inclusion and exclusion criteria. The goal of traditional RCTs is to demonstrate product safety and efficacy. On the contrary, large simple trials main goal is to compare targeted outcomes from different available treatments among a diverse patient population. The study found that benefits to the crossover study method include researchers' ability to compare different treatment effectiveness and outcomes on the same patients.

"Late-stage interventional studies are currently being transformed because researchers are coming up with new trial designs to explore different types of data and outcomes," said Natalie DeMasi, senior analyst at Cutting Edge Information. "Interventional trial designs mainly vary in their focus on internal validity versus external validity and efficacy versus effectiveness."

In comparison to traditional RCTs, pragmatic RCTs prioritize external validity more. The overall objective of many pragmatic RCTs is to investigate the risks and benefits of available treatments. As for aggregated n-of-1 trials, they are a more specific type of crossover study where one patient takes a specific treatment for a set period of time and then changes treatment for the same time period. The data collected from this individual is then aggregated into meaningful and larger datasets.

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. Report highlights include:

  • Determining the best-fit post-marketing alignment for global and regional-level teams.
  • Identification of post-marketing study team staffing trends.
  • Key recommendations for planning studies per product.
  • Provide 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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