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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

A tale of many cities – new dictionary of place names reveals our heritage
2015-01-28

 

‘The Dictionary of Southern African Place Names’ provides not only the answers, but also gives insight into how our places and our people were shaped. Penned by three academics from the University of the Free State (UFS), it is the fourth edition of this fascinating book.

Prof Peter Raper from the UFS Unit for Language Facilitation and Empowerment, together with his colleagues Prof Theodorus du Plessis and Dr Lucie Möller, created more than a reference book. They provide the reader with deeper understanding of events, our heroes, beliefs, values, fears and aspirations.

Jonathan Ball Publishers describes the book as “the most comprehensive glossary of Southern African towns, villages, railway stations, mountains, rivers and beaches. The 9 000 short entries incorporate data from sources dating as far back as 1486, encapsulating the linguistic and cultural heritage of all the peoples of the subcontinent, past and present.”

And what would the origin of the name Bloemfontein be?

This dictionary provides the following answer.

“Capital city of the Free State and judicial capital of South Africa. It was established in 1846 by Major HD Warden at a fountain on the farm Bloemfontein, originally owned by a Griqua, Mauritz Pretorius. It has been claimed to have been named after a person with the surname Bloem, or in honour of the Khoikhoi chief Jan Bloem, or after an ox with this name. Probably, however, it was named after flowers growing at the fountain, from Dutch bloem, ‘flower’, fonteijn, ‘spring’. The name is thought to be a translation from a Bushman name of which Mangaung is the Sotho adaptation; ma- is the Sotho plural prefix or class marker; the component ngau is comparable to the Bushman word //au, ‘flower’, and the final ng is cognate with the locative demonstrative ?, ‘that (one) there’. Bloemfontein attained municipal status in 1880.”




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