RESEARCH IN AFRICA
“Health research is increasing in quality and
quantity in Africa.”
This was the message of hope by Dr. Mickael Maganga; the Head of the Africa office of the European and Developing Countries Clinical Trials Partnerships (EDCTP).It was during the celebration of 10 years of excellence of DNDi in June, 2013.
He went on to explain how Africa’s research and regulatory bodies are doing a commendable job. First, the ethics and Regulatory reviews bodies have increased.
Few examples include the Tropical Disease Research
(TDR), the Swedish International Development Agency (SIDA) and Department for
Research Cooperation (SAREC), the European Union, the Bill & Melinda Gates
Foundation, the International Clinical Epidemiology Network (INCLEN), the
Fogarty International Center of the US, National Institutes of Health (NIH) and
the Welcome Trust. This has led to better governance and accountability for
health projects. Operation is more organised.
Other initiatives:
- Courses on
ethics are being offered. We have the South African Research Ethics
Training Initiative (SARETI) and West African Bioethics Initiative (WAB).
- Capacity
Building is through formal education projects networking long term and
short term training. “The staffs are even sent abroad in some cases,” confirmed
Dr. Ahmed Musa of the Gedaref State Ministry of health and DNDi.
- Online
training programmes from TRREE and ERECCA project that allows people to take
refresher courses on Good Clinical Practice (GCP).
- A
Regulatory pathway formulated by the MARC project –AVAREF- was launched in
2006 in collaboration with WHO.
- Operations
of the EDTCP Ethics activities are now in 23 countries in Africa They work
at institutional and national level. The most successful response is
coming from Nigeria ,Uganda and Tanzania with 33, 15 and 13 applications
respectively. This can be attested to the theory that the population of an
area is equally proportional to
the level of training. It is lowest in Liberia.
The sources of data include Surveys, Clinical
trials, Routine check up, Pre-trial population and evaluation. The variables
include Anthropometry, Spirometry, Cardiovascular, Biochemical, Age,
Psychological status
“These are useful for evaluating products for
optimum individual cares and preventing study teams from removing good product
from the market and adding bad ones, ”said Dr. Bernhards Ogutu, the Chief
research officer at KEMRI.
They are all meant to increase capacity for research
in Africa. They are effective so the bodies should be trusted.
Esnart Mwape, The Director of the Zambia Medicines
Regulatory Authorities added that the legal frameworks guiding the regulatory
authorities are not up to date.
“The NMRA’s are also poorly funded therefore
semi-functional. This leads to poor or even non-existent co-ordination”
It could be the reason why Samvel Azatyan, the
Manager of the Medicines Regulatory Support Programmes, WHO, mentioned that
“90% of Africa NMRA’s lack capacity to guarantee quality safety and efficacy
which results in lack of medicine affordability and availability.”
This leads to financial strains since they raise
funds from the resources they provide which means they give much and retain
little.
More challenges include shortage of skilled human
resource, poor infrastructure, poor co-ordination between ethics, and
regulatory structures and donors lack of awareness of gaps and potential and
inadequate collaboration.
We can only hope that in the next years, things
change for the better.
Labels: Africa, AVAREF, DNDI, EDCTP, ERECCA, Research, SARETI
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