Info

Source: Johnson et al. (2003).

"RR, response rate; TTP, time to progression; DFS, disease-free survival.

Source: Johnson et al. (2003).

"RR, response rate; TTP, time to progression; DFS, disease-free survival.

European guidelines reveals that outside the oncology and the muscoloskel-etal field, biomarkers in general and biomarker imaging in particular, are not considered surrogate endpoints. A list of imaging biomarkers endpoints accepted as primary endpoints for regulatory submissions and those suggested as endpoints in early development are listed in Table 2.

Overall, it is very complex to validate biomarkers to become surrogate endpoints, but the value of developing a biomarker resides in the information that can be obtained during such development. Among these benefits are the possibility of defining the population who may benefit from the drug candidate, the screening of patients for adverse events, the possibility to enrich the population for proof-of-concept studies, the possibility to stratify patients, the selection of doses for pivotal trials, and the potential for dose adjustments at patient level.

TABLE 2 Imaging Biomarkers: Review of Accepted Primary or Secondary Endpoints in the CHMP Guidelines

Condition

Imaging Accepted as a Primary Endpoint

Imaging Accepted as a Secondary Endpoint or Early in Development

Fungal infections

Relevant imaging is part

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