Department of Pathology, University of Stellenbosch, Stellenbosch, Cape Town, South Africa.
Department of Microbiology, Immunology and Tropical Medicine, George Washington University, Washington, District of Columbia, United States of America.
Contemp Clin Trials. 2022 May;116:106572. doi: 10.1016/j.cct.2021.106572. Epub 2021 Sep 25.
Translational research requires good quality specimens to ensure the integrity of research results. Clinical research must rely not only on quality specimens, but as well on clinical annotation for consistent, accurate and verifiable scientific and clinical outcomes. In laboratory research performed on a specimen by a single investigator, quality control is easily maintained. In a multi-site clinical research network, the numerous steps for biospecimens from procurement through transport, processing, storage and ultimately testing requires strict standardization of operational workflows and procedures. The practices of a central biorepository can inform and contribute to best practices regarding clinical research specimen integrity for multi-site clinical research.
转化研究需要高质量的标本，以确保研究结果的完整性。临床研究不仅必须依赖高质量的标本，还必须依赖临床注释，以确保科学和临床结果的一致性、准确性和可验证性。在由单一研究人员对标本进行的实验室研究中，很容易保持质量控制。在多站点临床研究网络中，从采购到运输、处理、存储，最终到测试的生物标本的众多步骤需要严格标准化操作流程和程序。中心生物库的实践可以为多站点临床研究的临床研究标本完整性提供信息，并有助于制定最佳实践。
