Expert panel approves phytotherapy clinical trial protocol for COVID-19

Ouagadougou, Burkina Fas, September 20 (Infosplusgabon) - The Regional Expert Committee on Traditional Medicine for COVID-19, formed by the World Health Organization (WHO), the African Centre for Disease Control and Prevention and the African Union Social Affairs Commission, has approved a protocol for Phase III clinical trials of herbal medicines for COVID-19 including a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials, WHO said in a statement.

"As in other areas of medicine, sound science is the only basis for safe and effective traditional medicine therapies," said Dr Prosper Tumusiime, Director of the Universal Health Coverage and Life Course Department at the WHO Regional Office for Africa.

"The emergence of COVID-19, like the Ebola epidemic in West Africa, has highlighted the need to strengthen health systems and accelerate research and development programmes, particularly on traditional medicines," said Dr Tumusiime.

The approved technical documents aim to strengthen and develop a critical mass of technical capacity of scientists in Africa to conduct appropriate clinical trials to ensure the quality, safety and efficacy of traditional medicines in accordance with international standards. Phase III clinical trials are essential to fully assess the safety and the efficacy of a new medical product.

The Data Safety and Control Board will ensure that the accumulated study data are periodically reviewed with respect to the safety of participants. It will also make recommendations on whether to continue, modify or stop a trial based on the evaluation of data at predetermined periods of the study.

If a traditional medicine product proves to be safe, effective and quality-assured, WHO will recommend rapid, large-scale local manufacture, explained Dr Tumusiime, noting that thanks to the African Vaccine Regulatory Forum, there is now a reference point against which clinical trials of drugs and vaccines in the Region can be evaluated and approved in less than 60 days.

"The adoption of the technical documents will ensure that universally acceptable clinical evidence of the efficacy of plant-based drugs for the treatment of COVID-19 will be produced without compromising the safety of participants," said Professor Motlalepula Gilbert Matsabisa, Chair of the Expert Committee.

He expressed the hope 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 to address the ongoing pandemic.

The 25 members of the Regional Expert Advisory Committee on Traditional Medicine for COVID-19 are responsible for supporting countries to improve research and development of traditional medicine based virus therapies and to provide advice on the implementation of approved protocols to generate scientific evidence on the quality, safety and efficacy of COVID-19 herbal medicines.

Members of the Committee are drawn from research institutes, national regulatory authorities, traditional medicine programmes, public health services, universities, medical and pharmaceutical professions and civil society organizations in the Member States.

FIN/ INFOSPLUSGABON/ARD/GABON2020

© Copyright  Infosplusgabon