1. Communicating regulatory high-throughput sequencing data using BioCompute Objects
- Author
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Charles Hadley S. King, Jonathon Keeney, Nuria Guimera, Souvik Das, Michiel Weber, Brian Fochtman, Mark O. Walderhaug, Sneh Talwar, Janisha A. Patel, Raja Mazumder, and Eric F. Donaldson
- Subjects
Pharmacology ,Pharmaceutical Preparations ,United States Food and Drug Administration ,Drug Discovery ,High-Throughput Nucleotide Sequencing ,Humans ,Reproducibility of Results ,United States - Abstract
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.
- Published
- 2022
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