About Us
Objectives
The overarching goal of this work package is to ensure all clinicians, researchers, and other collaborators active within the SNIP-AFRICA architecture can address basic training needs and engage in capacity building especially for collaborators from resource limited setting. This encompasses ensuring access to resources, knowledge sharing and a good understanding of adaptive platform trials but also the elaboration of skills relevant to ancillary laboratory research. Broadly, training and capacity building will focus on three areas: Methodology of clinical trials, Laboratory practices and workflows and supporting clinical care within neonatal sepsis trials. Our approach will be based on addressing relevant aspects of Scientific Thinking, Ethics, Quality and Risk Management, Research Operations and Study Management as well as providing wider development of Professional Skills. This will enable participating institutions to design, plan, implement and report on research meeting global standards and regulatory requirements, focusing on activities conducted within the SNIP-AFRICA architecture.
The specific objectives will be:
- To coordinate development, piloting, and provision of generic and platform-specific online training.
- To support and organise access to South-South and North-South on site training and capacity building
- To collaborate with relevant regional partners to optimise alignment of capacity development.
Description of work
Task 6.1 Coordinate development and provision of online training materials (M1 — M24)
For all areas that are being targeted for training and capacity building, online elements that can be accessed for self-paced online study, as webinars or seminars or as down-loadable resources, a standardised approach for development, piloting and ultimately provision of the training materials will be defined. Materials will be made available online and will ultimately be transferred entirely or in parts to a long-term online repository to preserve access to support for capacity building.
This task will be coordinated by KNUST.
Some introductory materials covering basics of clinical research and trials as well as more advanced trial designs relevant to the SNIP-AFRICA architecture will be developed and provided. Topics to be touched upon include the basic structure of an interventional study, ethical review and GCP/GMP, study documentation, and quality assurance systems. Particular attention will be paid to implementing trials in resource-constrained settings and trial conduct in vulnerable population. The exact content of these materials will be informed by a needs assessment among the SSA partners in the consortium.
This subtask will be led by KNUST with support from UCL and input from SU, ARCH, FETHI.
Introductory materials addressing GLP will be developed. Materials will address both clinical and laboratory staff audiences, providing insights into the importance of preanalytics and discussing key aspects of workflow for research laboratories. Laboratory quality assurance systems for trials will be outlined. Whenever possible, direct reference will be made to approaches and practices specified in operations manuals provided alongside research activities taking place within SNIP-AFRICA. Both microbiological and pharmacokinetic laboratory practices and workflows will be addressed.
This subtask will be led by KNUST with contributions from SU, ARCH and UA.
Training modules on the recognition and management of the sick septic neonate will be developed in collaboration with the African Neonatal Association (ANA). The focus of these materials will be on aspects immediately relevant for research activities within SNIP-AFRICA, for example, the correct approach towards using any risk scores, outlining approaches to antibiotic selection, de-escalation, and escalation and so on. Separate modules may be developed to provide a basic understanding of the problem of antimicrobial resistance in sick child healthcare in Africa, including information on key antimicrobials and how they should be used in treatment.
This subtask will be led by Penta with contributions from SGUL input from FETHI.
Opportunities will be created for SSA researchers to attend PopPK modelling courses in collaboration with ‘Pharmacometrics Africa’. Pharmacometrics Africa is a non-profit company aiming to develop quantitative clinical pharmacology among SSA scientists, and more generally among pharmacometricians in LMICs. SU will, in collaboration with Pharmacometrics Africa, host online PopPK training material and modules which will be made available free of charge to trainees. The aim is to strengthen PopPK capacity among young researchers in SSA with a focus on dose optimisation of antimicrobials in neonates and infants.
This subtask will be led by SU.
Task 6.2 Support accessing on-site training and capacity building opportunities (M12 – M60)
A number of face-to-face training and capacity-building opportunities relevant to researchers working within SNIPAFRICA have been identified and can be provided throughout the lifetime of the project. The WPLs will work with Task leads to ensure that the following are respected whenever possible and appropriate: (i) Early-career African researchers should be prioritised in accessing on site courses, trainings and visits, especially those undertaking a PhD working on SNIP-AFRICA; (ii) South-South mentoring and capacity building is to be preferred over NorthSouth opportunities to strengthen African research interactions; (iii) All “Train the Trainers” opportunities should be exploited to maximise the utility of onsite training for SNIP-AFRICA partners; (iv) Attention should be given to maintaining a good balance for attendance of researchers from all African partner sites, avoiding overrepresentation of researchers from one institution to the detriment of other institutions.
This task will be coordinated by KNUST.
UCL will make participation to several courses available to early career SSA researchers, waiving course fees. Examples are the UCL Monitoring Course and UCL Short Course on Patient and Public Involvement in Trials. Additional courses will be available through the Institute of Clinical Trials and Methodology at UCL, for example Clinical Trials Project Management or Statistical and Practical Aspects of the Design/Analysis of Multi-Arm Multi-Stage Platform Trials.
This subtask will be led by UCL.
African researchers will be given the opportunity to shadow Protocol Review Committee (PRC) meetings at UCL (virtual attendance possible). The purpose of this committee is to ensure adherence to SPIRIT guidelines, determine likely feasibility and assure compliance with GCP principles. This could be scaled up to introduce trained staff to join as formal members and input on the development and implementation of protocols running in the global South. It is planned that several SSA researchers will be hosted at UCL to arrange training and discussion with the Data Management System Team and to discuss Quality Assurance Systems and research delivery.
This subtask will be led by UCL.
Building on the laboratory training modules accessible online, direct virtual and face-to-face interactions will enable training on more complex aspects of the laboratory workflow and good microbiological laboratory techniques. ARCH, as an experienced SSA partner will provide such training jointly with UA. Data validation and bioinformatics analysis training on an easy-to-use “automated” bioinformatics pipeline will be provided by the UA for any genomic analyses, including whole-genome sequencing of stored isolates.
This subtask will be co-led by ARCH and UA.
The Division of Clinical Pharmacology at SU has an analytical pharmacology laboratory with the technical expertise to perform assays to quantify antimicrobial drugs on small plasma sample volumes. SSA researchers will have the opportunity to visit to transfer know-how and technical knowledge related to antimicrobial drug assays.
This subtask will be led by SU.
Task 6.3 Collaborate with regional partners to optimally align capacity development (M1 – M54)
All training and capacity building activities will take place in the context of strong existing ties to relevant regional initiatives to avoid duplication of efforts and to ensure that critical gaps are plugged by the SNIP-AFRICA efforts. Close alignment will be sought with the EDCTP-funded African coaLition for Epidemic Research, Response and Training (ALERRT) and PAN-African Network for Rapid Research, Response, Relief and Preparedness for Infectious Disease Epidemics (PANDORA) projects and the African Neonatal Association (ANA) and any projects co-funded through the current EDCTP3 call.
This task will be led by KNUST in collaboration with Penta and input from FETHI.