Basket cases: how real-world testing for drugs approved based on basket trials might lead to false diagnoses, patient risks, and squandered resources

J Clin Oncol

14 January 2020 - Basket trials, studies designed to assess the safety and efficacy of therapeutics targeted to a specific molecular alteration, regardless of cancer type, are becoming increasingly common in oncology.

A recent review identified 37 basket trials in, sponsored both by the National Institutes of Health and the pharmaceutical industry.

Basket trial designs are attractive to both academic researchers and industry because they provide an opportunity to identify response to a targeted therapy in small numbers of patients while validating a clinical target across tumour types. 

Successes such as the National Cancer Institute Molecular Analysis for Therapy Choice (MATCH) study and recent US FDA approvals of agents evaluated using basket trial designs will likely shift many therapeutic paradigms from organ based to treatment based on a molecular signature.

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Michael Wonder

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Michael Wonder