Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development.

ABSTRACT: Next-generation sequencing (NGS) and decreased costs of genomic testing are changing the paradigm in precision medicine and continue to fuel innovation. Integration of NGS into clinical drug development has the potential to accelerate clinical trial conduct and ultimately will shape the landscape of clinical care by making it easier to identify patients who would benefit from particular therapy(ies) and to monitor treatment outcomes with less invasive tests. This has led to an increased use of NGS service providers by pharmaceutical sponsors: to screen patients for clinical trials eligibility and for patient stratification, expanded Companion Diagnostic (CDx) development for treatment recommendations and Comprehensive Genomic profiling (CGP). These changes are reshaping the face of clinica

SUBMITTER: Menard T 

PROVIDER: S-EPMC8332578 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature