Africa endorses protocol for COVID-19 herbal medicine clinical trials

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The Regional Expert Committee on Traditional Medicine for COVID-19 formed by the World Health Organization (WHO), the Africa Centre for Disease Control and Prevention and the African Union Commission for Social Affairs has endorsed a protocol for phase III clinical trials of herbal medicine for COVID-19 as well as a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.

“Just like other areas of medicine, sound science is the sole basis for safe and effective traditional medicine therapies,” said Dr Prosper Tumusiime, Director of Universal Health Coverage and Life Course Cluster at WHO Regional Office for Africa.

“The onset of COVID-19, like the Ebola outbreak in West Africa, has highlighted the need for strengthened health systems and accelerated research and development programmes, including on traditional medicines,” said Dr Tumusiime.

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The endorsed technical documents are aimed at empowering and developing a critical mass of technical capacity of scientists in Africa to conduct proper clinical trials to ensure quality, safety and efficacy of traditional medicines in line with international standards. Phase III clinical trials are pivotal in fully assessing the safety and efficacy of a new medical product. The data safety and monitoring board will ensure that the accumulated studies data are reviewed periodically against participants’ safety. It will also make recommendations on the continuation, modification or termination of a trial based on evaluation of data at predetermined periods during the study.

If a traditional medicine product is found to be safe, efficacious and quality-assured, WHO will recommend for a fast-tracked, large-scale local manufacturing, Dr Tumusiime explained, noting that through the African Vaccine Regulatory Forum, there is now a benchmark upon which clinical trials of medicines and vaccines in the region can be assessed and approved in fewer than 60 days.

“The adoption of the technical documents will ensure that universally acceptable clinical evidence of the efficacy of herbal medicines for the treatment of COVID-19 are generated without compromising the safety of participants,” said Professor Motlalepula Gilbert Matsabisa, the Expert Committee Chairman. He voiced hope that that the generic clinical trial protocol will be immediately used by scientists in the region to ensure that people can benefit from the potential of traditional medicine in dealing with the ongoing pandemic.

The 25-members of the Regional Expert Advisory Committee on Traditional Medicine for COVID-19 are tasked with supporting countries to enhance research and development of traditional medicine-based therapies against the virus and provide guidance on the implementation of the approved protocols to generate scientific evidence on the quality, safety and efficacy of herbal medicines for COVID-19.

The Committee members are from research institutions, national regulatory authorities, traditional medicine programmes, public health departments, academia, medical and pharmacy professions and civil society organizations of Member States.

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