According to a recent study published in JAMA Oncology, a significant proportion of oncology drugs approved in Japan are based on non-randomized trials. The study analyzed data from the Japanese Pharmaceuticals and Medical Devices Agency and found that of the 82 oncology drugs approved between 2010 and 2019, 40% were approved based on non-randomized trials. This is in contrast to the United States and Europe, where randomized controlled trials are the gold standard for drug approval. The study authors note that non-randomized trials may not provide as robust evidence of a drug’s safety and efficacy, and call for increased transparency and public disclosure of the data used to support drug approvals. The findings of this study have implications for both patients and clinicians in Japan, as well as for the global pharmaceutical industry.

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