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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

Human Rights Desk takes up anti-xenophobia initiative
2015-05-06

In light of the recent violent attacks on foreigners in South Africa, the University of the Free State’s (UFS) Human Rights Desk hosted a symposium on the issue of xenophobia on Wednesday 29 April 2015 on the Bloemfontein Campus. In collaboration with volunteers from the Institute of Reconciliation and Social Justice (IRSJ), students had the opportunity to discuss the underlying issues of the problem.

Joe Besigye, Numpumelelo Ngcobo, Phiwe Mathe, and Dr Christian Williams lead the symposium. The panel aimed at providing guidance, answers, and explanations to the different narratives offered in the wake of the conflict. The underlying reasons for the conflict were investigated, which included socio-economic factors as well as the afrocentric tone of the events. Possible aggravating factors – such as the misplacement of blame and a South African culture of entitlement – also came under scrutiny. In addition, the discussion looked at the need to take into account the perspectives of non-South Africans on African conflicts.

After the symposium, Kovsie students gathered at the Thakaneng Bridge where Vice-Chancellor and Rector, Prof Jonathan Jansen, addressed the group. Carrying posters with ‘No to Xenophobia’ messages, the students then marched across the campus to show their support for anti-xenophobia.

The IRSJ – which the Human Rights Desk forms part of – has spearheaded the No-to-Racism/Yes-to-Equality Campaign launched in March 2015 across all three campuses. Under the guidance of the IRSJ, the Kovsie community has regularly been publicly showing their solidarity against all forms of discrimination.

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