RESEARCH TRIANGLE PARK, NC--(Marketwired - March 02, 2017) - Sixty one percent of surveyed clinical trial teams favor traditional randomized controlled trials (RCTs) over other interventional study trial designs during Phase 4, according to a study by pharmaceutical business intelligence firm Cutting Edge Information.
The recently published study, Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, surveyed global, US and country-level post-marketing study teams. The study found that 30% of surveyed traditional RCTs are commitment trials -- those required by a regulatory agency -- because these types of studies are geared toward collecting product efficacy and safety, which are top priorities for regulatory agencies.
In a similar vein, traditional RCTs are also very successful in gathering additional safety data and investigating new indications, patient populations or dosing -- each of which constitute 20% of surveyed studies. Although traditional RCTs tend to focus on efficacy, 20% of these surveyed studies do investigate long-term effectiveness. Finally, the remaining 10% of surveyed traditional RCTs are comparator trials.
"Late-stage interventional studies are undergoing a transformation as researchers innovate new trial designs to explore different types of data and outcomes," said Natalie DeMasi, research team leader at Cutting Edge Information. "Interventional trial designs vary in their focus on internal validity versus external validity and efficacy versus effectiveness."
The study also found that 32% of interventional trials use mobile technology to collect data, which allows for teams to collect data in real-time, faster than ever before. Using mobile technology also prohibits errors in transcribing physician or patient handwriting. Aside from data collection, the study found that 14% of interventional studies surveyed used mobile technology and social media to recruit patients. However, leveraging digital technology depends on a number of factors:
- Trial type
- Trial design
- Patient population
- Trial cost
Teams that weigh these considerations before including digital technology in their studies will maximize the benefits of mobile health (mHealth) and social media for clinical trials.
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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