EMA Gears Up for Raw Data Review Pilot Program
The European Medicines Agency (EMA) is inviting sponsors to apply for participation in a pilot program that will assess the benefits of submitting and assessing “raw data” during reviews by the Committee for Medicinal Products for Human Use (CHMP).
CHMP’s current review process primarily involves the assessment of data in clinical summaries and information in trial reports, which come in a format that “does not directly allow disaggregation or any other form of further analysis,” the EMA said. But for some regulatory procedures, it may be beneficial to have access to raw data — individual, electronically formatted patient data from trials that are directly available for reanalysis, additional analysis and visualization — during a CHMP review, the agency said.
“Access to raw [data] can assist regulators in understanding the submitted evidence and therefore inform the regulatory decisions on the benefit-risk balance of the product,” the EMA said in a document outlining the pilot. The agency noted that it reflected on previous reviews involving raw data and found a number of benefits, including an improved understanding of study results that informed approvals, fewer questions for applicants and optimized inspections.
The pilot program will kick off in September, when participants in the program will be allowed to submit raw data as part of their initial marketing authorization applications and postauthorization applications. The pilot will run for up to two years and take approximately 10 applications.
To apply for the pilot, email firstname.lastname@example.org.