FDA Decisions on China-based Trials Speeds Transition to Multiregional Clinical Trials

The US Food and Drug Administration (FDA) has taken an increasingly tough stance on clinical trials performed primarily in China in recent years, with the agency rejecting two drugs for that reason just last month. A recent article by Richard Pazdur, director of the Oncology Center of Excellence at the FDA, lays out some of the agency’s key concerns with trials performed in a single foreign nation.

According to Ben Hargreaves, “One significant factor centred on the generalisability of data gathered when applied to the US population, with intrinsic factors, such as genetic dissimilarity of populations, and extrinsic factors, such as difference in medical practice, raised as potential problems.

Pazdur noted, ‘The degree of regulatory flexibility in establishing the acceptability of data from a single country and its generalisability to a new population should be balanced against the drug’s innovation.’”

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(Source: Pharma Phorum, June 14^th, 2022)