For regulatory submissions of next generation sequencing (NGS) data it is vital for the analysis workflow to be robust, reproducible, and understandable. This project demonstrates that the use of the IEEE 2791-2020 Standard, (BioCompute objects [BCO]) enables complete and concise communication of NGS data analysis results. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data. Two separate, independent analyses were then carried out using BCOs as the tool for communication of analysis: one to simulate a pharmaceutical regulatory submission to the FDA, and another to simulate the FDA review. The two results were compared and tabulated for concordance analysis: of the 118 simulated patient samples generated, the final results of 117 (99.15%) were in agreement. This high concordance rate demonstrates the ability of a BCO, when a verification kit is included, to effectively capture and clearly communicate NGS analyses within regulatory submissions. BCO promotes transparency and induces reproducibility, thereby reinforcing trust in the regulatory submission process.

中文翻译：

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使用BioCompute对象传达监管高通量测序数据

对于监管机构提交的下一代测序（NGS）数据，至关重要的是分析工作流必须健壮，可重现和易于理解。该项目表明，使用IEEE 2791-2020标准（BioCompute对象[BCO]）可以实现NGS数据分析结果的完整而简洁的通信。使用类似于真实生物学数据的合成生成的数据来复制一项临床试验。然后，使用BCO作为分析交流工具进行了两次独立的独立分析：一种模拟向FDA提交药物法规，另一种模拟FDA审查。比较两个结果并将结果制成表格以进行一致性分析：在生成的118个模拟患者样本中，有117个最终结果（占99.15％）是一致的。如此高的一致性率表明，当包含验证工具包时，BCO能够有效捕获并清楚地传达监管意见书中的NGS分析。BCO可以提高透明度并提高可重复性，从而增强对法规提交过程的信任。