Barriers and bottlenecks
Getting the trials started was a challenge, even for the DNDi, which has lots of experience working in the continent. Regulatory approvals presented a major bottleneck, says Strub-Wourgaft. So, ANTICOV collaborated with the WHO’s African Vaccine Regulatory Forum (AVAREF) to set up an emergency process for joint reviews of clinical studies in 13 countries. This could speed up regulatory and ethical approvals.
“It allows us to bring countries, regulators and ethics-review-committee members together,” says Strub-Wourgaft.
Nick White, a specialist in tropical medicine who chairs the COVID-19 Clinical Research Coalition, an international collaboration to find solutions to COVID-19 in low-income countries, says that although the WHO initiative is good, it still takes longer to obtain approvals for studies in low- and middle-income nations than it does in wealthy ones. The reasons include strict regulatory regimes in these nations, and authorities that are unskilled at navigating ethical and regulatory review. This is something that has to change, says White.
“If countries want to find the solutions to COVID-19, they should help their researchers to do the necessary research, not obstruct them.”
But the challenges don’t stop there. Fowotade says that logistics and inadequate electrical supplies can stall progress once a trial starts. She was storing COVID-19 samples in a −20 °C freezer at the hospital in Ibadan when it experienced power outages. She also needed to transport the samples to a centre in Ede for analysis, a two-hour drive away. “I sometimes feel worried about the integrity of the stored samples,” Fowotade says.
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Olagunju adds that recruiting trial participants became even more difficult when some states stopped funding COVID-19 isolation centres in their hospitals. Without those resources, only patients who could afford to pay were admitted.
“We planned and started our trial based on the knowledge that the government was responsible for funding isolation and treatment centres. Nobody expected that to be interrupted,” says Olagunju.
And although it’s generally well resourced, Nigeria is notably not a participant in ANTICOV.
“Everybody avoids Nigeria to do clinical trials because we are not organised,” says Oyewale Tomori, a virologist and chair of Nigeria’s Ministerial Expert Advisory Committee on COVID-19, which works to identify effective strategies and best practices for responding to COVID-19.
Babatunde Salako, director-general of the Nigerian Institute of Medical Research in Lagos, disagrees with that view. Salako says that Nigeria has the knowledge to conduct clinical trials as well as hospitals for recruitment and a vibrant ethics-review committee, which coordinates approvals for clinical trials in Nigeria.
“In terms of infrastructure, yes, it may be weak; it can still support clinical trials,” he says.
Ndwandwe wants to encourage more African researchers to join clinical trials so that its citizens can have equitable access to promising therapies. Local trials can help researchers to identify pragmatic treatments. And they can address the specific needs of low-resource settings and contribute to better health outcomes, says Hellen Mnjalla, a clinical-trials manager at the Kenya Medical Research Institute–Wellcome Trust Research Programme in Kilifi.
“COVID-19 is a new infectious disease, so we need to do clinical trials to understand how these interventions are going to work on African populations,” adds Ndwandwe.
Salim Abdool Karim hopes that the crisis will spur African scientists to build on some of the research infrastructure that had been set up to fight the HIV/AIDS epidemic.
“The infrastructure is well developed in some countries like Kenya, Uganda and South Africa. But it’s less developed in others,” he says.
To bolster clinical trials for COVID-19 treatments in Africa, Salim Abdool Karim suggests establishing a body such as the Consortium for COVID-19 Vaccine Clinical Trials (CONCVACT; created in July 2020 by the Africa Centres for Disease Control and Prevention) to coordinate treatment trials on the continent. The African Union — the continental body representing the 55 African member states — is well placed to take that responsibility. “They’re already doing it for vaccines, so that could be extended for treatments too,” says Salim Abdool Karim.
The COVID-19 pandemic, says Sow, can be overcome only through international collaboration and equitable partnerships. “In the global fight against infectious diseases, a country can never go alone — not even a continent can,” he says.
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Source: Nature