The study, recently published by pharmaceutical business intelligence firm Cutting Edge Information, explained that this is due to their experience with physicians and medical information groups.
According to the report, the medical affairs team is one of the most involved in Phase IV study development. Of the Ph IV teams surveyed as part of the reserach, 75% reported that medical affairs functions remain “a constant presence during post-marketing execution.”
Additionally, 93% of medical affairs teams are involved in the strategic planning process for Ph IV studies, according to the report – although only 68% participate in the study execution process.
“Phase IV studies are undergoing a revolution,” Natalie DeMasi, Research Team Leader at Cutting Edge Information, told us.
Notably, she explained that Phase IV studies are no longer seen as optional.
“The need to collect health economic outcomes is one high priority reason why postmarketing studies are becoming more popular,” DeMasi said. “Phase IV studies have become crucial for earning product reimbursement and market share.”
Collecting ‘true real-world data’
The goal of a Ph IV study is to refine the understating of a medication in the real-world. However, through the research, DeMasi said the company was surprised to learn that that there is some debate on whether sponsor companies should provide the product to patients who participate in prospective observational studies.
“By definition, drug manufacturers should not have any influence on study participants throughout observational trials. Trial teams should allow clinicians and patients to make the best treatment decisions,” she explained.
According to the report, some drug companies feel they must offer their product, as healthcare systems don’t always want to provide or reimburse the drug. However, as DeMasi explained, contributing to the treatment plan in this way could impact study outcomes.
“Essentially, providing the treatment option is an intervention — more aligned with a traditional clinical trial,” she said, “and by providing the product, that action classifies the study as an interventional trial and no longer qualifies as collecting true real-world data.”