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.
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.
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