By Wallace Mawire
The Clinical Trial Community (CTC) a versatile, comprehensive, and accessible platform providing quick and real-time visibility of African clinical trials sites, capacity, and capability has been set up.
The first of its kind on the continent, the CTC platform also links relevant initiatives that support the conduct of trials, enables timely ethics and regulatory review and provides country level guidelines for import/export of relevant clinical supplies and bio-specimens. The platform aims to reduce bias in funding across countries and disease areas and promote synergy and efficiency across strategic funders in the product development ecosystem. Although this project was already underway, the worldwide rush to develop diagnostics, drugs and vaccines for COVID-19 provides a sense of urgency to develop this one-stop source of information for operational logistics in conducting clinical trials in Africa.
Research capabilities in Africa are improving with more robustly trained local researchers working in better equipped facilities. This ensures that African countries lead and collaborate in all phases of early to late-stage clinical trials. The CTC saves on cost and time associated with landscape analysis and although it captures African clinical trials at the start, the aim is to expand the community to other parts of the world.
CTC, an output of the Coalition for African Research and Innovation (CARI), is supported through a global partnership led by Johnson & Johnson, the US National institutes of Health (NIH), Wellcome, the Bill & Melinda Gates Foundation and World Economic Forum (WEF). CARI, conceived as an ambitious platform by African and Global partners and implemented through the Alliance for Accelerating Excellence in Science in Africa (AESA), is a well-funded, strongly supported and highly coordinated platform that leverages resource mobilisation for investment, undertakes strategic advocacy to harness leadership and fosters systematic collaboration to achieve outcomes that would help more Africans lead better lives sooner.
Other partners of CTC instrumental in the development of the clinical trials database include the World Health Organization (WHO) created African Vaccine Regulatory Forum (AVAREF), the Coalition for Epidemic Preparedness Innovations (CEPI), the Institute for Health Metrics and Evaluation (IHME), Pan African Clinical Trials Registry (PACTR), the European and Developing Countries Clinical Trials Partnership (EDCTP), the Africa Centres for Disease Control and Prevention (Africa CDC) and Drugs for Neglected Diseases Initiative (DNDi).
Announcing the establishment of the clinical trial community Prof Tom Kariuki, Director of Programmes/AESA Director, African Academy of Sciences (AAS) said, “The incredible diversity in Africa is unlike anywhere else in the world. The continent is made up of many cultures and ethnic groups whose genetic makeup impact clinical trial outcomes. It is very important that more trials are conducted on African soil. Unfortunately, the process of finding experienced investigators, trial centres/sites, existing and future trials, and determining the in-country processes and regulations to be followed to achieve correct regulatory approvals has been very difficult to do. With the CTC platform, researchers and possible funders will have a comprehensive source of intelligence on country-level clinical trial capabilities and processes which will aid in decision making.”
Dirk Gille, Vice President, R&D Capacity Development Leader, Global Public Health at Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson added: “The Clinical Trials Community platform will be an incredibly valuable tool in the successful execution of clinical trials in Africa. Bringing together essential information on clinical trial site capabilities, coupled with regional disease burden, will help enable the implementation of trials in the right centres and regions. While the ability to connect with scientists through the platform will further drive efficiencies and create opportunities. Ultimately, this should contribute to an increase in the number of clinical trials on the continent and, in time, accelerate access to innovative medicines for patients in Africa and around the world.”
“Sustained efforts to expedite development of clinical interventions against diseases rampant in Africa requires good capacity and networking of scientists and their trial sites. CTC couldn’t have been started at a better time when the world is challenged by epidemics on top of the high infectious diseases and rising non-communicable disease burden in Africa. The CTC will make African scientists and their sites more visible and reachable for concerted response in development of clinical interventions the continent and the world urgently need,” said Dr Thomas Nyirenda, EDTCP Strategic Partnerships & Capacity Development Manager, who is also chair of the CTC Advisory Committee providing strategic guidance to the AESA programme.
Diadié Maiga, the Regional Vaccine Regulation Officer at AVAREF, says: “We have seen a noticeable gap in the availability of information to trial sponsors and trialists, which is crucial to ensure clinical trials take place and for participants to be recruited. By showcasing the regulatory and ethical requirements, approval processes, timelines, and guidelines for conducting trials in the different countries across the continent, the CTC is a value add to the landscape that will promote knowledge sharing, awareness, trust, confidence and hopefully participation in clinical trials for the ultimate benefit of African people.”
“As key partners of the COVID-19 Vaccine Clinical Trial (CONCVACT) consortium, the Africa CDC aims to ensure that sufficient data is generated on the safety and efficacy of the most promising vaccine candidates for the African population so once vaccines are formally approved, they can be rolled out in Africa with confidence about their impact. The overlaid trial sites, country regulatory processes, and diseases burden data on display on the African map provided on the CTC platform will set the criteria for trial site selection guidance to potential clinical trial sponsors,” Nicaise Ndembi, Chief Science Advisor, Africa Centre for Disease Control and Prevention (Africa CDC).
“The CTC and partners are committed to supporting, enabling and accelerating investment in clinical and translational research capacity in Africa to effectively respond to disease outbreaks, reduce preventable deaths, strengthen productivity, improve quality of life, and to address countries public health needs. The recent outbreak of Covid-19 has shown us how important this type of collaboration really is,” says Dr Jenniffer Mabuka, CTC Consultant.