Clinical research is a critical field of medical science focused on studying health...
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Biomarkers are measurable biological indicators—such as proteins, genes, or imaging results—that reflect normal biological processes, disease progression, or response to a therapeutic intervention. Surrogate endpoints, on the other hand, are specific types of biomarkers used in clinical trials as substitutes for direct measures of how a patient feels, functions, or survives (i.e., clinical outcomes). Surrogate endpoints are critical in accelerating drug development and regulatory approvals, especially in areas like oncology, cardiology, neurology, and rare diseases where waiting for long-term clinical outcomes is impractical. However, not all biomarkers are validated surrogate endpoints. To be used as such, a biomarker must show a strong and consistent correlation with the actual clinical benefit.
Types of Biomarkers (Predictive, Prognostic, Diagnostic) · Validation of Surrogate Endpoints · Genomic and Proteomic Biomarkers · Biomarkers in Oncology Trials · Pharmacodynamic and Pharmacokinetic Biomarkers · Use in Drug Labeling and Approval · FDA and EMA Guidelines · Imaging Biomarkers · Fluid-Based Biomarkers (e.g., Blood, CSF) · Digital Biomarkers · Risk of Misinterpretation or Over-Reliance · Statistical Correlation with Clinical Outcomes · Companion Diagnostics · Biomarker Qualification Programs · Emerging Biomarkers in Personalized Medicine