FDA aims to better understand immunotherapy in the ‘real world’
“The treatment of cancer patients has been transformed through the emergence of new therapies that act through an individual’s immune system,” Rebecca Kush Ph.D., scientific innovation officer at Elligo Health Research told Outsourcing-Pharma.com.
However, following FDA-approval of immunotherapies to treat various cancer, Kush explained the agency “wishes to better understand the safety effects of such drugs in the ‘real world,’ in addition to safety data from clinical trials.”
To do so, the US Health and Human Services (HHS) Food and Drug Administration (FDA) has tasked Elligo with a project to evaluate the use of “harmonized data models” to gather real-world data. The award is part of a grant from the Patient-Centered Outcomes Research (PCOR) Trust Fund to synchronize multiple common data models and open standards.
“Currently, there are multiple different ways to collect and represent research data, which can hinder cross-study comparisons,” Kush explained. “The resulting opportunity for interoperability among the models is expected to facilitate evidence generation and make it easier to aggregate and interpret clinical data.”
The project is scheduled to take approximately one year and will leverage electronic health records (EHRs) as data sources and the architecture resulting from the PCOR Trust Fund project.
Specific data sources are currently being vetted, Kush said.
“The promise of real-world data for research is great; however, the ultimate value will come from being able to rapidly share high-quality data from electronic health records and other electronic health data sources,” she added.
Kush said the project’s results should help “pave a path” towards the availability of data from which to evaluate drug safety.
