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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
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Trial geography, pharmacogenetics, and global drug development
R N Schuck1, J Florian, R Charlab
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Clinical Pharmacology and Therapeutics
|February 12, 2015
Summary
Global drug development faces challenges from regional variations in clinical practice, environment, and genetics. Understanding these factors is key to interpreting multiregional trial outcomes and improving drug response globally.
Area of Science:
- Pharmacogenomics
- Global Health
- Drug Development
Background:
- Drug development is increasingly globalized, necessitating multiregional clinical trials (MRCTs) for comprehensive safety and efficacy evaluation.
- Significant variability in clinical practice, environmental exposures, and genetic factors exists across geographic regions.
- This regional variability can impact drug pharmacokinetics and treatment response, affecting both localized and global trial outcomes relative to the United States.
Purpose of the Study:
- To highlight the influence of regional variations on multiregional clinical trial outcomes.
- To emphasize the importance of considering intrinsic factors, such as genetics, in understanding drug response variability.
- To underscore the role of advancing genomic technologies in addressing these challenges.
Main Methods:
- Review of factors influencing drug development in a global context.
- Analysis of the impact of geographic variability on clinical trial data.
- Exploration of genomic technologies for understanding pharmacokinetics and response.
Main Results:
- Regional differences in clinical practice, environment, and genetics significantly affect drug trial outcomes.
- Genomic factors present a key area for investigation to explain observed regional variability.
- Advancements in genomic research offer tools to address these complexities in drug development.
Conclusions:
- Addressing regional variability is crucial for successful global drug development.
- Genomic insights are essential for optimizing drug efficacy and safety across diverse populations.
- Future research should leverage genomic technologies to interpret and mitigate regional differences in drug response.
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