German Agency Says EMA Adaptive Pathway Remains Vague on Real-World Evidence

Less than a week after the EMA issued a report on its adaptive pathway, a German agency is taking the agency to task for leaving stakeholders in the dark on real-world evidence use.

The German Institute for Quality and Efficiency in Health Care criticized the agency’s failure to disclose details on the candidates that advanced through the pilot program, which serves as a new approval route for therapies treating unmet needs and relied in part on real-world data.

The German agency contended that the EMA’s report glosses over candidate examples that showcase how real-world evidence will play into the approval process, under the guise of industry confidentiality.