In previous years, regulatory science analyses have provided evidence that a significant amount of regulatory approvals by the EMA and FDA are based on a single pivotal trial . This analysis aimed to investigate whether the trend continues. 
Out of all approvals between 2017-2019, 44% of all NMEs have been approved based on a single pivotal trial. The majority of these are oncology and/or orphan products, accounting for 86 % of the approvals supported by a single pivotal trial. Furthermore, where previously the majority of ap-provals based on a single pivotal trial had supportive evidence in the form of non-pivotal, interven-tional trials, from 2017 to 2019 24 % have no supporting efficacy evidence from other trials. Instead supportive evidence comes from within the pivotal trial itself or from non-interventional clinical trials.

Regulatory approvals based on a single pivotal trial (2017-2019): Characteristics and use of supportive evidence

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