Strengthening research capacity benefits scientists, product developers and disease-endemic countries
Dr Opokua Ofori-Anyinam was excited to be working on a candidate malaria vaccine at the pharmaceutical firm GlaxoSmithKline in Belgium in the late 1990’s. She had had to work hard while growing up in Ghana to get the training she needed – training which was still not available to many. The result was that research in Africa was rarely led by Africans at that time.
Dr Ofori-Anyinam and her GSK supervisor, Professor Nadia Tornieporth, brainstormed on ways to build the capacity of the next generation of African researchers. Prof Tornieporth then went to TDR with a proposal – create a training programme for mid-career scientists from low- and middle-income countries, with GSK as the first pharmaceutical company hosting fellows for one year. By 1999, what is now called the TDR Clinical Research and Development Fellowship (CRDF) was in place, and the first trainee was Professor Mahamadou Thera from Mali.
Professor Thera is now head of the Mali Malaria Clinical Development for Vaccines Unit of the Malaria Research and Training Center. He has been principal investigator of several clinical trials that assessed blood-stage malaria vaccine candidates and malaria drugs.
TDR fellows’ contribution to the world’s first malaria vaccine
Professor Thera’s pioneering success paved the way for many others. During GSK’s development of its RTS,S malaria vaccine, at least half of its TDR fellows went on to be either lead investigators or collaborators back in their home institutions. For example, Dr Roma Chilengi returned to Zambia after his Fellowship, and worked in various African research Institutes on projects including the RTS,S vaccine. He is now the Chief Scientific Officer at the Centre for Infectious Disease Research, where he oversees all research and training programmes, including the roll-out of Rotavirus vaccines in Zambia.
Stronger R&D capacity contributes to stronger product development
In 2014, the European and Developing Countries Clinical Trials Partnership joined TDR as a joint implementer of the fellowship, and the programme has expanded to include hosts from 17 different pharmaceutical companies, product development partnerships and research organizations.
These organizations are starting to see their investments pay off. In a recent external evaluation of the CRDF, the host institutions rated the resulting local staff’s knowledge and capacity to conduct clinical trials a 4 on a scale of 1-5, and 3.1 for knowledge of regulatory issues (with 5 being the highest). These are the areas that have been of greatest concern to host institutions with respect to clinical trials conducted in low- and middle-income countries.
Both career advancement and impact on research and development in these countries are being noted among the 91 fellows from 31 countries that have been trained since 1999.
Dr Ofori-Anyinam, who is now the Director of Clinical Research and Epidemiology, Diseases of the Developing World, at GSK Vaccines, explains, “Giving them the tools for their own independence has created a strong network of capable scientists and improved infrastructure in these countries.”
Each organization provides both professional training and mentoring, a key factor in the success of the programme. The fellows spend a year away from families, and this close support is critical not only to ensure academic and interpersonal development, but also to forge long-lasting relationships. “We develop close relationships with the fellows during their stay at our office in Heidelberg, and we continue to support and mentor the fellows after their return,” says Nicola Viebig, the fellowship coordinator at the European Vaccine Initiative (EVI), which has hosted seven fellows since 2015.
The fellowship year allows for reciprocal and in-depth exchange, and often leads to improvement of EVI´s own activities. Dr Viebig adds, “We have a real appreciation for what the fellows can teach us.”
María del Mar Castro Noriega from Colombia is also a former CRDF fellow hosted by EVI. Based on her implementation experience in the field, she shared her insights on issues to consider for a leishmaniasis vaccine. In particular, she pointed out that Colombian people suffering from leishmaniasis might not seek out doctors due to geographic barriers, conflict, transportation costs, and stigma.
EVI has been successful in enabling its fellows to develop strong skills in project and grant management and technical expertise in vaccine development principles and clinical methodologies. After their return, fellows often transfer their newly acquired skills and expertise to their home institutions, by way of training workshops.
After completing her fellowship, Dr Castro Noriega used the TDR reintegration grant to develop a digital tool to follow up trial progress in CIDEIM’s on-going leishmaniasis projects, an approach that could be customized for other diseases and projects.
Addressing gender equity
Dr Castro Noriega is one of the 24% of TDR fellows who are women. This is a field still dominated by men in low- and middle-income countries and the fellowship programme is trying to increase gender equity. It is a challenge, as Opokua Ofori-Anyinam acknowledges. “We select people in their 30s and 40s, and the women often have young children who they have to leave for a year,” she says. “It takes strong women and caring men to support this effort.”
Fellowships lead to expanded partnerships and capacity
At Fiocruz – a national public health research institute of 70 technical units across Brazil – Clarisse Dah from Burkina Faso, a doctor with hospital experience in infectious diseases, worked on studies on malaria, dengue, leishmaniasis and medical marijuana. There, she learned how to plan for human resources and manage pharmacovigilance, data and safety.
The success of the CRDF programme at Fiocruz has encouraged the organization to expand international agreements. One of these will allow the organization to work with Burkina Faso in future projects, and to share staff and participate in local trials.
“We are helping to build a culture of research. It doesn’t matter what disease the fellows start with – in the end, it is about gaining knowledge of the process and putting in place the systems behind it,” says GSK’s Ofori-Anyinam. “This helps both the institutions supporting clinical product development, and most importantly, the people who will benefit from these new diagnostics, vaccines and treatments.”
For more information, contact Pascal Launois.