Duffy Caitlyn, Santana Victor, Inaba Hiroto, Jeha Sima, Pauley Jennifer, Sniderman Liz, Ghara Niharendu, Mushtaq Naureen, Narula Gaurav, Bhakta Nickhill, Rodriguez-Galindo Carlos, Brandt Heather
Department of Oncology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.
Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.
Implement Sci Commun. 2022 Jun 11;3(1):62. doi: 10.1186/s43058-022-00310-5.
The recent implementation of novel therapies has accelerated progress in pediatric cancer care. Despite the significantly poorer survival of patients in low- and middle-income countries (LMICs), administation complexities and other significant resource barriers have limited the translation of these novel therapies in these regions. This study aims to develop a model that can be used to support the implementation of novel therapies, such as blinatumomab (bispecific antibody therapy for B-cell acute lymphoblastic leukemia [B-ALL]) in LMIC centers, with the long-term goal of developing an implementation framework for similar future efforts.
In this study, mixed methods will be applied to understand the key contextual considerations that can be accounted for through a training program and prospectively designed implementation activities. The Consolidated Framework for Implementation Research will guide the activities related to implementation evaluation in parallel with a drug donation program. A multidisciplinary research team comprising high- and low-middle income healthcare professionals, industry, and implementation scientists has been assembled with the common goal of improving safe access to blinatumomab. To assess the factors affecting blinatumomab administration, semi-structured interviews with diverse collaborators and quantitative assessments of organizational characteristics will be conducted, together with quantitative and qualitative assessments of feasibility, acceptability, appropriateness, and cost of blinatumomab implementation. A quantitative assessment of stakeholder perceptions of different implementation strategies used as part of the multifaceted approach will also be performed. Finally, we will examine the key domains and processes used and construct the implementation roadmap for translation of novel therapies.
This study will rigorously develop an implementation roadmap for translation of novel therapies in low-resource settings. The knowledge gained in the formative assessment will reveal the priority areas and key implementation strategies. Thereby, the resultant roadmap will facilitate future scale-out strategies for novel therapies in LMICs, thus increasing access, building capacity for management, and ultimately improving the care for children in LMICs.
新型疗法的近期实施加速了儿科癌症护理的进展。尽管低收入和中等收入国家（LMIC）患者的生存率明显更低，但管理复杂性和其他重大资源障碍限制了这些新型疗法在这些地区的推广。本研究旨在开发一种模型，可用于支持在LMIC中心实施新型疗法，如blinatumomab（用于B细胞急性淋巴细胞白血病[B-ALL]的双特异性抗体疗法），其长期目标是为未来类似工作制定实施框架。
在本研究中，将采用混合方法来了解可通过培训计划和前瞻性设计的实施活动加以考虑的关键背景因素。实施研究综合框架将指导与实施评估相关的活动，同时开展一项药品捐赠计划。一个由高收入、中低收入医疗保健专业人员、行业和实施科学家组成的多学科研究团队已组建起来，其共同目标是改善blinatumomab的安全可及性。为评估影响blinatumomab给药的因素，将与不同合作者进行半结构化访谈，并对组织特征进行定量评估，同时对blinatumomab实施的可行性、可接受性、适宜性和成本进行定量和定性评估。还将对利益相关者对作为多方面方法一部分使用的不同实施策略的看法进行定量评估。最后，我们将研究所使用的关键领域和流程，并构建新型疗法转化的实施路线图。
本研究将严格制定在资源匮乏环境中新型疗法转化的实施路线图。在形成性评估中获得的知识将揭示优先领域和关键实施策略。因此，由此产生的路线图将促进未来LMIC中新型疗法的扩大推广策略，从而增加可及性，建设管理能力，并最终改善LMIC中儿童的护理。
