Journal
DRUG DISCOVERY TODAY
Volume 27, Issue 4, Pages 1108-1114Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.drudis.2022.01.007
Keywords
Next generation sequencing (NGS); Regulatory submission; BioCompute Objects; HCV1a; Antiviral resistance; Single nucleotide polymorphism (SNP); Amino acid substitutions
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This project demonstrates the use of the IEEE 2791-2020 Standard (BioCompute Objects [BCO]) to enable clear communication of NGS analysis results. It replicates a clinical trial and performs two independent analyses to validate the consistency of the results, showcasing how a template BCO enhances confidence in the regulatory submission process.
This project demonstrates the use of the IEEE 2791-2020 Standard (BioCompute Objects [BCO]) to enable the complete and concise communication of results from next generation sequencing (NGS) analysis. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data and then two independent analyses were performed. The first simulated a pharmaceutical regulatory submission to the US Food and Drug Administration (FDA) including analysis of results and a BCO. The second simulated an FDA review that included an independent analysis of the submitted data. Of the 118 simulated patient samples generated, 117 (99.15%) were in agreement in the two analyses. This process exemplifies how a template BCO (tBCO), including a verification kit, facilitates transparency and reproducibility, thereby reinforcing confidence in the regulatory submission process.
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