NAIROBI, Kenya, Sept 20 – The Regional Expert Committee on Traditional Medicine for COVID-19 has endorsed a protocol for phase III clinical trials of herbal medicine for the disease as well as a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.
The committee was formed by the World Health Organization, the Africa Centre for Disease Control and Prevention, and the African Union Commission for Social Affairs.
In a statement, Dr. Prosper Tumusiime, the Director of Universal Health Coverage at WHO Regional Office for Africa says just like other areas of medicine, sound science is the sole basis for safe and effective traditional medicine therapies.
“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.
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.
This is 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.
According to Tumusiime, 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.
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.
They are also tasked with providing guidance on the implementation of the approved protocols to generate scientific evidence on the quality, safety and efficacy of herbal medicines for COVID-19.