Peck Roger, Storey Helen L, Barney Becky, Israeli Shirli, Halas Olivia, Oroszlan Deborah, Brodsky Shiri, Agarwal Neha, Murphy Eileen, Sagalovsky Mariana, Cohen Jessica, Trias Elizabeth, Schutzer Aaron, Boyle David S
PATH, Seattle, Washington, United States of America.
PLOS Glob Public Health. 2023 Aug 15;3(8):e0002044. doi: 10.1371/journal.pgph.0002044. eCollection 2023.
Diagnostics are critical tools that guide clinical decision-making for patient care and support disease surveillance. Despite its importance, developers and manufacturers often note that access to specimen panels and essential reagents is one of the key challenges in developing quality diagnostics, particularly in low-resource settings. A recent example, as the COVID-19 pandemic unfolded there was a need for clinical samples across the globe to support the rapid development of diagnostics. To address these challenges and gaps, PATH, a global nonprofit, along with its partners collaborated to create a COVID-19 biorepository to improve access to biological samples. Since then, the need for data resources to advance universal rapid diagnostic test (RDT) readers and noninvasive clinical measurement tools for screening children have also been identified and initiated. From biospecimens to data files, there are more similarities than differences in creating open-access repositories. And to ensure equitable technologies are developed, diverse sample panels and datasets are critical in the development process. Here we share one experience in creating open-access repositories as a case study to describe the steps taken, the key factors required to establish a biorepository, the ethical and legal frameworks that guided the initiative and the lessons learned. As diagnostic tools are evolving, more forms of data are critical to de-risk and accelerate early research and development (R&D) for products serving low resource settings. Creating physical and virtual repositories of freely available, well characterized, and high quality clinical and electronic data resources defray development costs to improve equitable access and test affordability.
诊断工具是指导临床决策以提供患者护理和支持疾病监测的关键手段。尽管其至关重要，但开发者和制造商经常指出，获取样本库和基本试剂是开发高质量诊断工具的关键挑战之一，在资源匮乏地区尤其如此。一个近期的例子是，随着新冠疫情的蔓延，全球都需要临床样本以支持诊断工具的快速开发。为应对这些挑战和差距，全球非营利组织PATH及其合作伙伴共同协作创建了一个新冠生物样本库，以改善生物样本的获取。自那时起，人们还认识到并启动了对数据资源的需求，以推动通用快速诊断测试（RDT）阅读器以及用于筛查儿童的非侵入性临床测量工具的发展。从生物样本到数据文件，创建开放获取库的相似之处多于不同之处。为确保开发出公平的技术，多样的样本库和数据集在开发过程中至关重要。在此，我们分享创建开放获取库的一次经历，作为案例研究来描述所采取的步骤、建立生物样本库所需的关键因素、指导该倡议的伦理和法律框架以及所吸取的经验教训。随着诊断工具的不断发展，更多形式的数据对于降低风险以及加速面向资源匮乏地区产品的早期研发至关重要。创建免费提供、特征明确且高质量的临床和电子数据资源的实体和虚拟库，可以降低开发成本，以改善公平获取并提高测试的可承受性。
