'25 at 25': Training and capacity strengthening
05 Sep 2024
Capacity strengthening is at the core of our clinical trials and methodology work, aiming to enhance the skills of trial teams we work with across the globe, so they can deliver their own sustainable, successful and impactful clinical trials.
At the centre of our capacity strengthening efforts is training. Our senior staff spend substantial time working with local staff in the countries where our trials are conducted, providing informal advice and support, as well as formal mentoring. We have developed and delivered short courses and workshops across all aspects of clinical trials research, including design and analysis, trial conduct and science communication to policymakers and the public. Statistical skills training has included courses for both statisticians and non-statisticians, as well as tailored training within trials. A key area on which to focus future training is the design and implementation of adaptive trials.
The Unit also hosts visitors, especially from low- and middle-income countries (LMICs), as we consider this a priority in building expertise and leadership. Visiting trialists have used their placements to conduct literature reviews, develop trial proposals, analyse data and prepare conference presentations. For example, in 2017, we hosted a clinical epidemiologist from Egypt. During the visit, staff helped her conduct a literature review and develop a study proposal. Her work contributed to two joint grants (MRC Global Health Trials and Gilead Sciences), for work on hepatitis C elimination in Egypt. Another example is that the PrEPVacc co-ordinating team from MRC Uganda Virus Institute and London School of Hygiene and Tropical Medicine (LSHTM) Uganda Research Unit spent a week in 2019 exploring the implementation of quality control measures for managing data and investigational products.
The methodology programme staff have also mentored visitors on internal placements and provided informal training on topics including platform trials, stratified medicine, meta-analysis and statistical methodology. Meanwhile, we have facilitated external placements for our staff.
Another important aspect of capacity strengthening is operational skill development. The Unit has delivered Good Clinical Practice (GCP) training in multiple LMIC settings including South Africa, India, Vietnam, Uganda, Mongolia, Ethiopia, Moldova and Georgia. Since 2020, we have begun to cascade some of our capacity strengthening activities. In the CHAPAS4 trial, for example, new centres in Zimbabwe (Bulawayo) and Zambia (Ndola) were largely mentored and set up by the Harare and Lusaka trial sites with oversight from our team. This involved personnel exchanges between the new and mentor site, training on GCP and other aspects of trial conduct, plus site initiation visits which the MRC CTU at UCL team joined remotely.
One of our main focuses in recent years has been on co-developing infrastructure, processes and tools in India. This builds on the strategic partnerships between the Unit and organisations such as the Clinical Development Services Agency (CDSA), the Tata Translational Cancer Research Centre (TTCRC) at Tata Medical Centre, Kolkata, and the Tata Memorial Centre (TMC), Mumbai.
Key achievements include creating a clinical trials toolkit for India and an integrated ethics application platform that multiple Indian institutions are now using. The former is based on the NIHR toolkit that evolved from the Medical Research Council’s clinical trials toolkit, to which our Unit made a major contribution. Additionally, the Unit has supported Indian academic research units with a focus on clinical trials through knowledge exchange and mentorship across all functional domains.
Furthermore, staff from the Unit spend a week each year in India at the International Collaboration for Research Methods Development in Oncology (CReDO) residential workshop for early career oncologists. There, our staff train young investigators to develop ideas into trial protocols and support them in securing funding to put these ideas into practice.
Indian organisations such as the CDSA at the Translational Health Science and Technology Institute have also sought our advice when developing their patient and public involvement (PPI strategies), and we now teach on their PPI modules as part of their MSc in clinical trials. We also run a short course that equips trial teams within and beyond our own Unit to plan and deliver effective patient and public involvement (PPI). It was co-developed and is co-led by one of our patient representatives from the Unit’s PPI Group.
As well as providing training, the Unit has supported our colleagues from LMICs to work towards formal research qualifications, such as PhDs and MScs. Several of our grants have included PhD studentships, for example BREATHER Plus has four PhD Studentships, while CHAPAS-4 had six funded African PhD students and had linked MSc students.
The Unit led the development and delivery of the first postgraduate taught programme on clinical trials in the UK. It covers all aspects of clinical trials and reflects the breadth of research within the MRC CTU at UCL. The MSc in Clinical Trials was formally launched in 2016. So far, we have had approximately 150 graduates from the Clinical Trials programme. Our students have come from over 20 countries in Europe, North and South America, Africa and Asia and a variety of educational backgrounds. We continue to review and revise the MSc programme to ensure we address current and innovative issues. We are also supporting CDSA in India in their MSc in Clinical Trials, and our staff teach on several of their MSc modules.
To share our knowledge in one globally accessible place, we launched the MRC CTU at UCL Capacity Strengthening Hub, hosted on the Global Health Network, based in Oxford. The aim of the Hub is to strengthen the clinical trials capacity of our LMIC partners.
The Hub targets individuals and organisations working on trials and observational studies globally, providing resources on the design, conduct, analysis, and knowledge transfer and exchange for randomised controlled trials, observational studies, and meta-analyses. People can search for resources in different ways, such as by subject, disease area or resource format. The resources include: Standard Operating Procedures, tools, templates and guidance, recorded presentations and training resources. There are also essential reading lists on specific areas, such as trial set-up, which are a compilation of resources from the Hub resources page. Once users complete a quiz, they are provided with a certificate.
To date, the Hub has had more than 9000 visitors from 142 countries. Users have viewed the Hub’s resources more than 27,000 times and downloaded them more 2,000 times.
The Hub was officially launched at a webinar in May 2023, led by Professor Sarah Walker. Since then, it has continued to host a webinar series. Webinars have mainly focused on how to excel in different roles in clinical trials, such as Trial Manager, PI and Data Manager. These events have been really well attended. At its peak, over 800 people from over 100 countries joined the ‘How to be a good Trial Manager’ webinar.
This year, we launched the LMIC Mentoring scheme on the Hub. The scheme aims to link those working on clinical trials and studies in different organisations and countries for online mentoring. Mentoring can be role-specific or for other goals such as career development, promotion, work-life balance, or building self-confidence.
Since the scheme’s launch, we have matched 58 mentors and mentees, with overwhelmingly positive feedback. One common theme is that, although mentors and mentees were sometimes unsure of why they had been matched when they were from different backgrounds and roles, after meeting they found they were well suited – in terms of the areas in which the mentee needed support and how the mentor was able to provide that support.
Our capacity strengthening efforts stretch across training, supporting students, mentoring, facilitating internal and external placements, and expanding our strategic partnerships in LMICs like India. The Hub on The Global health Network has improved access to online materials, widening our reach and improving linkage with those working on clinical trials around the world, particularly in LMICs.
Capacity strengthening is integral to our clinical trials and methodology work. It is an essential step towards LMICs to setting their own agendas, to ensure research is locally relevant and to design and deliver their own clinical trials.
Further information: