Clinical Validation History

 the way to approach complicating factors such as tumor heterogeneity and the choice of which genetic mutations to target

Researches on cancer, due to the rapid advancement of technologies, are able to broaden our understanding to the molecular level and sequencing of the genome of individuals can be made more quickly and less expensively. Development of target treatment agent for specific molecule (biomarker) is being carried out actively and precision medicine that can allow customized treatment of individual cancer patients is now possible through the sequenced genome information. Clinical test, in alignment with such trend, is also undergoing transition into quicker and more effective direction of checking only the responses to specific drugs in accordance with the molecular mutation in particular patient group by transcending the domain of the existing clinical tests that necessitates a lot of time and cost, and large patient groups.

Basket or bucket trials Umbrella trials Exceptional responder trials
History/ drug Variety of cancer types
Single drug targeting a single mutation
Single cancer or variety of cancer types
Multiple drugs targeting multiple mutations
Any cancer type and drug where a patient had an unusually robust clinical benefit
Advantages Can apply to various different carcinomas with mutation of corresponding gene
Ease of tracing drug / cause of target genes
Execute clinical experiment for individual drugs and diseases
Can evaluate multiple numbers of genes and drugs simultaneously in a single clinical test
Ease of drug research on rare carcinoma with multiple numbers of genes
Likelihood of finding a molecular characteristic that could account for the response
Informs patient selection for future trials
Disadvantages Evaluates only one drug/ mutation pair at a time Unable to draw definitive conclusions for a given drug/mutation pair in trials enrolling patients with a variety of cancers Large patient numbers, resource intense Molecular characteristics linked to clinical activity must be tested subsequently in a larger number of patients before drawing definitive conclusions Need access to broad array of testing platforms to evaluate potential characteristics that may account for the response
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