Many pharmaceutical companies with the capacity to manage Phase IV post-marketing trials in-house still choose to outsource a significant portion of the work, a new US report reveals.
According to researchers from Cutting Edge Information, 55.2% of the companies surveyed for Phase IV Clinical Trials: Post-Marketing Management Structure, Strategy and Benchmarks had the infrastructure in place to conduct Phase IV studies in-house. Yet within this segment, only 57.4% on average of the workload was actually managed internally.
This trend varied according to company size. Only 44% of the small companies and 40% of medium-sized companies surveyed had the necessary infrastructure for Phase IV trials, resulting in an average 68% and 80% respectively of the work being farmed out. Even though 80% of the large companies in the study had the means to conduct Phase IV in-house, an average 57% of study load still went outside.
Executives interviewed for the report cited the flexibility provided by outsourcing provided if they needed to shift gears quickly in clinical development. Conducting Phase IV in-house means implementing a single platform across the clinical operations organisation, Cutting Edge Information pointed out. This kind of standardisation can be “very taxing” in larger companies with multiple disciplines, even if they have internal capacity available.
But outsourcing has its pitfalls, noted research team leader John Hess. While it relieves companies of having to manage a field force and staffing logistics, “that comes at the cost of relinquishing control over study execution," he commented. By Peter Mansell