Lockwood Christina M, Merker Jason D, Bain Elizabeth, Compton Caroline, Grossman Robert L, Johann Donald, Jones Frederick, Jones Gregory, Kreifels Matthew, LeBlang Suzanne, Lee Jerry S H, Lyle John, Martini Jean-Francois, Saunders Lauren, Scher Howard, Somiari Stella, Stewart Mark, Vinson Jacob, Leiman Lauren C
Association for Molecular Pathology, Rockville, Maryland, USA.
Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA.
Clin Pharmacol Ther. 2025 Jan;117(1):28-33. doi: 10.1002/cpt.3416. Epub 2024 Aug 20.
BLOODPAC is a public-private consortium that develops best practices, coordinates clinical and translational research, and manages the BLOODPAC Data Commons to broadly support the liquid biopsy community and accelerate regulatory review to aid patient accessibility. BLOODPAC previously recommended 11 preanalytical minimal technical data elements (MTDEs) for BLOODPAC-sponsored studies and data submitted to BLOODPAC Data Commons. The current landscape analysis evaluates the overlap of the BLOODPAC MTDEs with current best practices, guidelines, and standards documents related to clinical and research liquid biopsy applications. Our findings indicate an existing high degree of concordance among these documents. Where differences exist, the BLOODPAC preanalytical MTDEs can be considered a minimal practicable set for organizations to utilize. These MTDEs were developed following extensive examination of best practices and iterative conversations with the U.S. FDA. BLOODPAC recommends the use of these MTDEs in submissions to data commons and to support liquid biopsy clinical trials and research globally.
BLOODPAC是一个公私合营的联盟，它制定最佳实践方案，协调临床和转化研究，并管理BLOODPAC数据共享库，以广泛支持液体活检领域，并加快监管审查，以帮助患者获得相关资源。BLOODPAC此前为其赞助的研究以及提交至BLOODPAC数据共享库的数据推荐了11个分析前最小技术数据元素（MTDE）。当前的态势分析评估了BLOODPAC的MTDE与当前临床和研究液体活检应用的最佳实践、指南及标准文件之间的重叠情况。我们的研究结果表明，这些文件之间目前存在高度一致性。若存在差异，BLOODPAC的分析前MTDE可被视为各组织可采用的最小可行集。这些MTDE是在对最佳实践进行广泛审查并与美国食品药品监督管理局进行反复沟通后制定的。BLOODPAC建议在向数据共享库提交的数据中使用这些MTDE，并支持全球范围内的液体活检临床试验和研究。
