Capacity building for a Centre of Design, Innovation and Translational Excellence (CITE) for clinical trials of healthcare technologies in SS Africa

尽管许多利益攸关方作出了许多努力，乌干达仍然是世界上孕产妇和婴儿死亡率最高的国家之一，截至2016年，孕产妇和婴儿死亡率分别为每10万名新生儿中有336人死亡，每1000名活产中有55人死亡。由于缺乏训练有素的卫生专业人员，获得高质量的孕产妇和新生儿保健的机会正在变得紧张，乌干达的医生与患者比例比世界卫生组织建议的最低标准高出25倍。乌干达人口的最大比例生活在农村社区，由于距离大型卫生设施很远，获得专科护理是一个重大挑战。采用了教育、宣传、增加获得药物的机会和熟练的助产等方法来改善结果。然而，乌干达和其他中低收入国家的许多母亲死于产后出血、先兆子痫和疟疾等疾病，而新生儿死亡主要是由于肺炎、败血症等疾病。非常明显的是，显然需要早期诊断、更好地获得治疗和改进监测。因此，迫切需要在资源有限的医疗保健系统中采用创新、成本效益高和可持续的具体方法，以降低孕产妇和新生儿死亡率。适当的技术创新提供了机会：一)大规模提供经济和有效的改善孕产妇和新生儿结果；二)取代不适合乌干达医疗保健系统和环境的现有技术；三)减少浪费；四)推动当地经济增长。乌干达在SSA中的独特之处在于，在学术界的推动和政府的支持下，乌干达正在生物医学工程、医疗诊断和技术以及医疗创新方面扩大当地的研究和技术专长。我们建议利用Makerere大学生物医学工程部和健康科学学院与爱丁堡大学之间的新战略合作，以加强我们拟议的跨学科设计、创新和翻译卓越中心(CITE)的能力，该中心最初专注于孕产妇和新生儿健康。我们的中长期目标是成为在该地区建设创新和能力的枢纽，作为刺激妇幼保健以外的创新的蓝图，并扩大我们的技术和研究专长，成为撒哈拉以南非洲生物医学工程领域学术卓越和创新的领先中心。我们最初的广泛目标是：(1)在乌干达的主要利益攸关方中传播关于本地制造的研究医疗设备(IMD)临床评估系统和流程的现有知识；(2)通过培训研究医疗设备的临床试验设计和监管此类设备的医疗写作，加强当地的研究能力。培训研讨会、赞助参加良好的相关课程以及在Makerere和爱丁堡临床试验单位之间进行基准访问是旨在实现这一目标的一些活动。这一目标的成果是培养一大批精通IMD试验设计的乌干达研究人员，具有孕产妇和新生儿健康试验方面的专门知识；以及(3)建立一个具有专门知识的多学科网络，以制定专为乌干达定制的调查性医疗设备监管框架草案。

Despite numerous efforts by many stakeholders, Uganda still has one of the highest maternal and infant mortality in the world with the maternal and infant mortality rates being 336 deaths per 100,000 births, and 55 per 1,000 live births, respectively as of 2016. Access to quality maternal and neonatal healthcare is being stretched by lack of access to trained health professionals with doctor to patient ratios in Uganda being 25 times higher than the minimum recommended by the WHO. The biggest percentage of Uganda's population live in rural communities where access to specialised care is a major challenge due to long distances to big health facilities. Approaches such as education, advocacy, increasing access to medicine and skilled birth attendance have been used to improve outcomes. However, many mothers in Uganda and other Low and Middle Income countries are dying due to conditions such as postpartum haemorrhage, preeclampsia and malaria, whereas neonatal mortality is mainly due to conditions such as pneumonia, sepsis among others. What is very evident is the clear need for early diagnosis, better access to therapy and improved monitoring. There is therefore an urgent need for innovative, cost effective and sustainable context specific approaches to healthcare delivery, which can reduce maternal and neonatal mortality within a resource limited healthcare system.Appropriate technological innovations present an opportunity to i) deliver economic and efficient improvements in maternal and neonatal outcomes at scale, ii) replace existing technologies which are not designed for the Ugandan healthcare systems and environment, iii) reduce waste and iv) drive local economic growth. Uganda is uniquely placed in SSA in that, driven by academia and supported by the Government, it is expanding local research and technical expertise in biomedical engineering, healthcare diagnostics and technologies and healthcare innovation. We propose to capitalise on a new strategic collaboration between the University of Makerere Biomedical Engineering Unit and College of Health Sciences, and the University of Edinburgh to strengthen capacity for our proposed interdisciplinary Centre of Design, Innovation and Translational Excellence (CITE), initially focused on maternal and neonatal health. Our medium to long-term aspiration is to act as a hub to build innovation and capacity in the region, to act as a blueprint to stimulate innovations beyond maternal and child health and to expand our technological and research expertise to become the leading centre for academic excellence and innovations in biomedical engineering in sub-Saharan Africa. Our initial broad objectives are: (1) To map existing knowledge about the systems and processes for clinical evaluation of locally made Investigational Medical Devices (IMD) amongst key stakeholders in Uganda; (2) To strengthen local research capacity through training on clinical trial design for investigational medical devices and medical writing for the regulation of such devices. Training seminars, sponsorships to attend good relevant courses and exchange bench-marking visits between Makerere and Edinburgh Clinical Trials Units are some of the activities aimed at achieving this objective. The output of this objective is develop a critical mass of Ugandan researchers knowledgeable in IMD trial design, with specific expertise on trials in maternal and neonatal health; and (3) To establish a multi-disciplinary network with the expertise to develop a draft regulatory framework for Investigational Medical Devices, bespoke for Uganda.