FAQ - CDx : Clinical Development 
 

How early should CDx clinical evidence strategy be defined?

Ideally, CDx clinical evidence strategy should be defined before pivotal therapeutic trials begin. This allows sponsors to ensure that samples are collected correctly, endpoints are aligned with regulatory expectations, and sufficient data will be available to support both the drug and the diagnostic.

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Why is sample governance important in CDx clinical trials?

Sample governance ensures that clinical specimens are collected, stored, transported, and tracked in a way that preserves their integrity and traceability. Regulators often scrutinize specimen management during CDx review because poor sample handling can undermine the validity of clinical data.

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What happens if the CDx clinical trial assay changes during development?

Assay evolution is common during development, but it must be carefully managed. Changes to assay platforms, reagents, or analytical methods may require bridging studies to demonstrate that results remain comparable. Without this evidence, regulators may question whether clinical trial data apply to the final marketed CDx.