Term of the Day
Natural History Study
A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.
A central laboratory plays an important role in clinical trials by providing a centralized location for the analysis of study samples, including blood, urine, and tissue samples. The main functions of a central laboratory in a clinical trial include:
- Sample processing and analysis: Central laboratories receive, process, and analyze study samples according to the study protocol. This may involve performing various tests to measure biomarkers, drug concentrations, or other study-specific endpoints.
- Quality control: Central laboratories are responsible for ensuring the accuracy and reliability of study data by implementing quality control measures, such as sample tracking, instrument calibration, and data verification.
- Standardization: Central laboratories often use standardized methodologies and procedures to ensure consistency across study sites and to minimize variability in study results.
- Data management: Central laboratories may provide data management services, such as data analysis and reporting, and may work with study sponsors to develop customized data reports.
- Regulatory compliance: Central laboratories are subject to regulatory oversight and are required to adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which ensure the integrity and reliability of study data.