Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials.

The primary difference between a biomarker and a surrogate marker 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 the current law 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 surrogate markers 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, still meeting the FDA’s expectations.

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Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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