Aijaz Javeria, Raza Muhammad Rafie, Sajid Kafeel Naz, Naseer Fouzia, Jawaid Nida, Jamal Saba, Bhakta Nickhill, Alexander Thomas B, Roberts Megan C
Molecular Pathology Section, Clinical Laboratories, Indus Hospital & Health Network, Karachi, Pakistan.
Biorepository Section, Clinical Laboratories, Indus Hospital & Health Network, Karachi, Pakistan.
PLoS One. 2025 May 16;20(5):e0321316. doi: 10.1371/journal.pone.0321316. eCollection 2025.
In low- and middle-income countries, limited infrastructure and resources hinder biobank establishment, affecting specimen diversity. Addressing this gap is crucial for equitable health outcomes, as current databases are skewed towards Northern-European populations. In Pakistan, pediatric cancer biobanks are non-existent. Indus Hospital & Health Network (IHHN) in Karachi, with its large pediatric cancer unit, aims to establish a biobank to address region-specific pediatric cancer research needs. This manuscript describes the biobank implementation process using implementation science frameworks.
The pediatric cancer biobank at IHHN collects FFPE specimens for solid tumors, and isolated mononuclear cells from peripheral blood and bone marrow of suspected acute leukemia. Implementation planning workgroups included clinicians, EMR, IT, management, senior leadership, IRB, and external support from UNC and St. Jude Children's Cancer Hospital. The selection of applicable ERIC (Expert Recommendations for Implementing Change) strategies through stakeholder workgroups considered scope, budget, and feasibility, and context. Standard protocols from ISBER and BCNet guided alignment with best practices. IHHN's past experiences and tacit knowledge gained through rapid, successful implementation also facilitated strategy selection. The EPIS framework (exploration, preparation, implementation, sustainment) was used to map and organize the selected intervention strategies.
Biobank implementation at IHHN, organized by EPIS stages, has been described through a set of 41 implementation strategies. Of these, 34 were selected out of 73 originally published ERIC strategies, while 7 were added based on contextually based workgroup consensus. 599 acute leukemia and 1137 solid tumor specimens have been banked since inception of the biobank operations 2 years earlier. The implementation activities and challenges described include infrastructure, swift specimen collection, prior to treatment, and informed consent. The ancillary processes including training and quality control have also been described and related data presented.
The implementation of Pakistan's first acute leukemia biobank using ERIC and EPIS frameworks offers a structured approach beneficial for settings with limited biobanking experience. This intervention aligns with recognized implementation science frameworks, while addressing aspects pertinent in low- and middle-income countries.
在低收入和中等收入国家，基础设施和资源有限阻碍了生物样本库的建立，影响了样本多样性。弥补这一差距对于实现公平的健康结果至关重要，因为目前的数据库偏向于北欧人群。在巴基斯坦，儿科癌症生物样本库并不存在。卡拉奇的印度河医院与健康网络（IHHN）拥有大型儿科癌症科室，旨在建立一个生物样本库，以满足特定地区儿科癌症研究的需求。本手稿使用实施科学框架描述了生物样本库的实施过程。
IHHN的儿科癌症生物样本库收集实体瘤的福尔马林固定石蜡包埋（FFPE）样本，以及疑似急性白血病患者外周血和骨髓中的单个核细胞。实施规划工作组包括临床医生、电子病历（EMR）、信息技术（IT）、管理人员、高级领导层、机构审查委员会（IRB），以及来自北卡罗来纳大学（UNC）和圣裘德儿童癌症医院的外部支持。通过利益相关者工作组选择适用的ERIC（实施变革专家建议）策略时考虑了范围、预算、可行性和背景。国际生物和环境样本库协会（ISBER）和BCNet的标准协议指导了与最佳实践的一致性。IHHN过去通过快速、成功的实施获得的经验和隐性知识也有助于策略的选择。EPIS框架（探索、准备、实施、维持）用于绘制和组织选定的干预策略。
通过EPIS阶段组织的IHHN生物样本库实施过程，已通过一组41项实施策略进行了描述。其中，从最初发布的73项ERIC策略中选择了34项，另外7项是根据基于背景的工作组共识添加的。自两年前生物样本库运营开始以来，已储存了599份急性白血病样本和1137份实体瘤样本。描述的实施活动和挑战包括基础设施、治疗前的快速样本采集以及知情同意。还描述了包括培训和质量控制在内的辅助过程，并展示了相关数据。
使用ERIC和EPIS框架实施巴基斯坦首个急性白血病生物样本库，提供了一种结构化方法，对生物样本库经验有限的环境有益。这种干预符合公认的实施科学框架，同时解决了低收入和中等收入国家相关的问题。
