BRAZZAVILLE - The regional expert committee on traditional medicine for coronavirus (Covid-19) set up jointly by the World Health Organisation, the Africa Centres 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, the WHO said on Saturday.
“Just like other areas of medicine, sound science is the sole basis for safe and effective traditional medicine therapies,” WHO regional office for Africa universal health coverage and life course cluster director Dr Prosper Tumusiime said in a statement.
“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,” Tumusiime said.
The endorsed technical documents were 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 were pivotal in fully assessing the safety and efficacy of a new medical product. The data safety and monitoring board would ensure that the accumulated studies data were reviewed periodically against participants’ safety. It would 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 was found to be safe, efficacious, and quality-assured, WHO would recommend fast-tracked, large-scale local manufacturing, Tumusiime said.
He noted that through the African Vaccine Regulatory Forum there was now a benchmark upon which clinical trials of medicines and vaccines in the region could 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,” committee chairman Professor Motlalepula Gilbert Matsabisa said in the statement.
He expressed hope that the generic clinical trial protocol would be immediately used by scientists in the region to ensure that people could benefit from the potential of traditional medicine in dealing with the ongoing pandemic.
The 25-member committee was tasked with supporting countries to enhance research and development of traditional medicine-based therapies against the virus and provide guidance on the implementation of approved protocols to generate scientific evidence on the quality, safety, and efficacy of herbal medicines for Covid-19.
The committee members were from research institutions, national regulatory authorities, traditional medicine programmes, public health departments, academia, medical and pharmacy professions, and civil society organisations of member states, the statement said.
IOL