New Delhi (NVI): The Regional Expert Committee on Traditional Medicine for COVID-19 has approved a protocol for Phase 3 clinical trials of African herbal medicine for coronavirus.
The expert committee formed by the World Health Organization (WHO), in collaboration with the African Centre for Disease Control and Prevention and the African Union Commission for Social Affairs, also endorsed 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 Prosper Tumusiime, Director of Universal Health Coverage and Life Course Cluster at WHO Regional Office for Africa.
Moreover, the technical documents that were approved 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, the WHO said in a statement.
This appears to add to the global effort to develop vaccines for the coronavirus disease, which are at different trial stages, it added.
The Phase 3 clinical trials are crucial 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, the WHO stated.
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.
Tumusiime further explained that 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 WHO also noted 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 added 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
However, it is to 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.
-RJV
