Regional expert panel endorses protocol for COVID-19 herbal medicine clinical trials
The Regional Expert Committee on Traditional Medicine for COVID-19 has endorsed a protocol for phase III clinical trials of herbal medicine for COVID-19.
They have also endorsed a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.
The panel formed by the World Health Organization, the Africa Centre for Disease Control and Prevention and the African Union Commission for Social Affairs made the endorsement on 19th September, 2020.
Dr Prosper Tumusiime, Director of Universal Health Coverage and Life Course Cluster at WHO Regional Office for Africa said, “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,” added 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 which 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.
Dr Tumusiime 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.”
He 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 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.