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12 November 2019 | Story Leonie Bolleurs | Photo Leonie Bolleurs
Farmovs
At a first for South Africa, the SACRA clinical trials capacity-building workshop with government, research institutions, and industry, were from the left: Dr Nathaniel Mofolo, Dr Rita Nathan, Dr Mojalefa Maseloa (Head: Clinical Services in the Clinical Unit at the Universitas Hospital) and Sue Baily (Site Management Head at IQVIA).

Whether it is to treat the flu or a more serious illness, all medicines go through a very costly and lengthy research process before being approved for prescription to patients. The cumulative time from the beginning of trials to marketing approval has increased over the past ten years. 

According to Dr Vathi Papu-Zamxaka from the South African Clinical Research Association (SACRA), South Africans would not have had access to safe and effective medicines, had it not been for the intensive research conducted on new medicines. 

On 7 November 2019, a group of 115 delegates representing the Free State Department of Health, the UFS, private research sites, and the pharmaceutical industry met at FARMOVS on the Bloemfontein Campus of the University of the Free State (UFS) for the SACRA clinical trials capacity-building workshop.

2,1 billion dollars to develop one successful drug

Dr Michelle Middle, Chief Medical Officer at FARMOVS, provided some interesting stats on the process for drugs to hit the shelves: “One out of 10 drugs entering human research will be approved. The cost of development of one successful drug is approximately 2,1 billion dollars. And the time to develop a drug, from submission of the Investigational New Drug Application (IND) to approval by the Food and Drug Administration (FDA), is between 12 and 15 years.”

Dr Middle stated that drug development is one of the most regulated processes, with ethics and patient safety governing the undertaking. “With SAHPRA (South African Health Products Regulatory Agency) having some of the strictest regulations in the world, South Africa has a good history of running trials.  In addition, fast growth is expected for the pharmaceutical market on the African continent, necessitating the need for increased clinical trials on this continent,” she said. 

Very few clinical trials hosted in South Africa 

Although Africa has the broadest genetic variability of all human populations and carries 17% of the global population, very few clinical trials are hosted on the continent. Globally, there are currently approximately 322 000 clinical trials being actively conducted, of which only 1 700 are conducted in Africa, i.e. less than 3%.  Even worse, only 304 of the 1 700 trials running in Africa are conducted in South Africa.  There is thus a critical need for South Africa as a country to market itself as a clinical trial destination and to attract more trials to the country.

South Africa’s competitive edge lies in being known for its ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)-compliant top-quality research, racial and genetic diverse trial participants, good medical infrastructure and expertise, and the good reputation of the regulator (SAHPRA). “There are, however, a need for transformation and capacity building in clinical research in the country,” said Dr Middle. 

Dr Rita Nathan, Head of Clinical Services in the Clinical Department at the Universitas Hospital, who was representing government at the workshop, is looking to strengthen clinical trials across government and industry by focusing on, among others, funding models, operations management, and service delivery. 

From the UFS Faculty of Health Sciences, Dr Nathaniel Mofolo, Head of the School of Clinical Medicine, said collaboration between stakeholders is important. “This initiative is giving direction to the UFS vision of being a research-led university.” 

Other topics discussed at the workshop include the clinical trials landscape, how clinical trials work, the patient factor, ethics in clinical trials, and the economic aspect of clinical trials. 

News Archive

UFS enhances Geography in schools
2015-05-11

The Green Box

The Department of Geography at the University of the Free State (UFS), in association with the Society of South African Geographers (SSAG), is doing their part in providing curriculum support to schools. Dr Ruth Massey and Anneri Pretorius are the project managers of Green Box, an initiative to advance Geography in schools.

The Green Box supports the intermediate phase of schooling (Grades 4, 5, 6). According to Dr Massey, the worksheets and activities provided in the Green Box are aligned with the Curriculum and Assessment Policy Statements (CAPS) and the new curriculum. “These worksheets are divided into three themes: map work, physical Geography, and human Geography.

“Map work includes symbols and keys, grid references, and compass work whilst physical Geography focuses on water and waste, biodiversity and conservation, and weather and climate issues. The human Geography theme has a focus on population, rural and urban development, migration, food and farming, and transport and trade,” she said.

Each worksheet has a fact sheet section which teaches theory on the specific topic (linked to the curriculum), an activity section (all resources needed for these activities are provided in the box), and a ‘take it home’ section for further learning and practice at home.

The Green Box is a recycled plastic crate that comprises worksheets, training materials, visual aids, and resources for teaching, learning, and active engagement in Geography classes.

Also included in the box are a felt story board and characters (that link with the worksheet activities), the ‘Climate Change memory game’ (which enhances learner’s memory capabilities and teaches various climate change facts) and the ‘Sustainable Development puzzle game’ (which teaches about the social, biophysical, economic, and political elements of Sustainable Development, and how they overlap).

“All items in the box are locally sourced, robust, and without copyright,” said Dr Massey.

The project is focusing on 10 under-resourced schools in the Bloemfontein area. Each school has received three boxes (one for each grade of the Intermediate Phase).

Dr Massey said: “This box is to be shared among the teachers. The Green Boxes were distributed at a training and information workshop held at three central schools in the various districts. These workshops introduced the teachers to the contents of their box, and provided basic training on the worksheets and the activities provided.”

“The schools will be joined up with ‘Box Buddies’ at more resourced schools in Bloemfontein. These buddy schools will assist in support and in replenishing the box’s stationery, etc. when needed.”

“Monitoring and evaluation will take place for six months after the boxes have been distributed. This will ensure support to, and the sustainability of, the project.” The Green Box project was made possible through a grant from the Society of South African Geographers (SSAG).

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