Biomarkers and Surrogate Endpoints

Surrogate endpoints to predict clinical benefits or biological effects

Interest is increasing rapidly in using surrogate endpoints as primary measures of the effectiveness of investigational drugs in definitive drug trials.
The primary difference between a biomarker and a surrogate endpoint is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment.

While laws and regulations permit the FDA to base the approval of a drug product on a determination of the drug’s effect on an unvalidated surrogate marker, there might be several difficulties in interpreting trials that use them as primary measures of drug effect.

In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.

Biomarker’s Strategy

Insightful strategy is the most effective way to ensure quality when including biomarkers into your product development plan.

Validation or Qualification

Understanding where to go if biomarker validation takes your study in a different direction can create valuable efficiencies in bringing a product to market.

Accelerated orphan drug approval: surrogate endpoints

C Fratazzi and J Niu

World Journal of Advanced Pharmaceutical and Medical Research, 2022, 02(01), 001–007

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