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Related Experiment Video

Updated: Mar 16, 2026

High-throughput Fluorometric Measurement of Potential Soil Extracellular Enzyme Activities

High-throughput Fluorometric Measurement of Potential Soil Extracellular Enzyme Activities

Published on: November 15, 2013

[Not Available].

Xavier Paoletti¹, Federico Rotolo¹, Stefan Michiels¹

¹Gustave Roussy ; Service de biostatistique et d'épidémiologie ; Inserm U1018 CESP, Université Paris-Sud, Université Paris-Saclay, Equipe OncoStat; 114 rue Ed. Vaillant 94805 Villejuif cedex.

Bulletin Du Cancer

|August 7, 2016

Summary

This summary is machine-generated.

Biomarkers show treatment activity early, but validating them as surrogate endpoints requires demonstrating they carry the same information as final endpoints. Formal validation can disappoint, even with strong biological rationale.

Keywords:

Biomarker,pathological Biomarqueur Cellules tumorales Circulating tumor cells Overall survival Réponse pathologique Surrogate Survie globale circulantes response

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Area of Science:

Oncology
Biostatistics
Clinical Trial Design

Background:

Advances in biology and biotechnology offer numerous biomarkers for treatment activity.
Understanding cancer treatment mechanisms aids early efficacy evaluation.
Biomarkers are promising for early assessment of cancer treatment effects.

Purpose of the Study:

To explore criteria for validating biomarkers as acceptable surrogate endpoints.
To differentiate between individual and trial-level information provided by biomarkers.
To assess the reliability of biomarkers in predicting treatment outcomes in clinical trials.

Main Methods:

Review of biomarker validation principles in randomized clinical trials.
Analysis of case studies in prostate, gastric, and early breast cancer.
Distinction between individual patient monitoring and trial-level prediction.

Main Results:

Biomarker validation requires demonstrating equivalent information to final endpoints.
Two distinct levels of information (individual and trial) must be considered.
Formal validation of biomarkers as surrogates can be disappointing, despite biological rationale.

Conclusions:

Careful validation is crucial before using biomarkers as surrogate endpoints.
Biomarker utility depends on their ability to predict treatment effects on final outcomes.
Biological plausibility alone does not guarantee a biomarker's surrogate status.