Boosting clinical trials in Africa
With less than three percent clinical trials in the continent, the Association for Good Clinical Practice in Nigeria (AGCPN) in collaboration with National Agency for Food and Drug Administration and Control (NAFDAC) has called for the sustainable increase participation in global clinical trials, to build capacity for African indigenous scientists to creatively harness natural products with medicinal potentials for global consumption.
AGCPN under the guidance of Prof Ifeoma Okoye, Consultant Radiologist University of Nigeria Teaching Hospital (UNTH) on Tuesday kicked off the first all Africa Clinical Trial Summit, which would be concluded today, June 8,2017.
Okoye at the summit, with the theme: “Next Frontier for Growth and Revolution in Clinical Trials: Africa is ready” said it is necessary to collaboratively partner with stakeholders to potentiate its next phase of activities and foster a mutually beneficial collaborative partnership that speaks to meet the initiative. .
Okoye added: “Africans have come to conclusion that the low volume of drug research and development is counterproductive to the vision to healthy Africa. As has been widely recognized, the health status of the African population remains behind that of populations in Europe and North America, as well as many other developing regions with similar affluence. There is overwhelming evidence that demonstrates that meeting Africa’s development goal in healthcare and access to medicine requires that we build sustainable platform for health innovation in Africa.”
Acting Director General, NAFDAC, Mrs. Yetunde Oni said the country is evolving from its economic challenges as well as being confronted with the challenge of curtailing public health emergencies in some parts of the country.
She added: “The African continent has been, in the past few years, faced with challenges of combating threats of disease outbreaks, especially with the recent Ebola Viral Disease (EVD) in West Africa. This Ebola virus outbreak exposed the lack of capacity in many countries to provide oversight for clinical trials for all medical products, but simultaneously, it showed the contribution of the African Vaccine Regulatory Forum (AVAREF) to building expertise and facilitated the timely review of candidate vaccines.”
Oni continued: “This swift pace of product development has challenged regulatory systems globally, especially those of resource-constrained Sub-Saharan African countries, to come to terms with the reality of pooling their efforts together and attract medical research to the continent.”
She urged all stakeholders to be committed in their various fields of endeavour and be equipped for the challenges ahead. “NAFDAC in its quest to achieve international best practice in all its regulatory activities, has given priority to enhancing collaboration and cooperation to ensure availability of good quality, safe and efficacious drugs and other regulated products. The Agency, in its effort to contribute to this goal has positioned herself through its legal mandate to regulate food and drugs in Nigeria. Clinical Trial Regulations and guidelines have also been put in place to give effect to these laws,” said Oni.
President, Bioresources Development Group (BDG) Prof. Maurice Iwu said, the clinical trial is the ultimate proof of efficacy and safety products and they take it serious.
He added: “We exchange ideas find out how best to do it and listen to what is going on. It is a way of taking stock of what happened from last year summit to this one but much more importantly is to exchange the ideas to how the best we will do it and we learn few things and also talk to colleagues in various areas to know how we can improve the clinical trials and also those who are in medical practice how they can also learn one or two things all for the betterment of the nation.”
Iwu continued: “There are few trials, but only organisation like ours that are able to sponsor it. It is a very expensive undertaking but without it we are not really sure the product that we are making is as effective as we claim to be. Both the cost, the human resources and the material resources are involved for example before you can make a drug that can be used for clinical trial it must be prepared in a certain manners that meets certain standard. Networking is going on people are talking to people at the end of the day some of collaboration will be set up. Suchstudies are done quietly without much publicity at certain stage so we are hopefully as the network is going on ultimately some problem will be resolved.”