CLN Article

New Framework Standardizes Communication of NGS Data for FDA Regulatory Review

Regulatory Roundup: December 2017

A consortium of healthcare stakeholders led by the Food and Drug Administration (FDA) and George Washington University (GWU) has published a new framework for communicating high-throughput sequencing computations and data analysis in research and clinical trials. Currently, computational researchers use a variety of bioinformatics software with different environments and parameters, which leads to variation in research protocols and difficulty reproducing results. The new framework, known as the BioCompute Object (BCO) Specification Document, strives to improve study reproducibility by establishing a common language for next-generation sequencing data. This will hopefully enable researchers to share and compare their work more effectively. The framework also aims to facilitate workflow exchange between FDA, biomedical companies, bioinformatics platform providers, and researchers as they move through FDA’s regulatory submission process. The BCO framework was created with input from more than 300 stakeholders who attended a recent workshop hosted by GWU in coordination with FDA, in addition to major contributions from investigators at Harvard Medical School and Seven Bridges Genomics.

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