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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

I don’t see myself as a star, says Wayde
2016-09-20

Description: Wayde and Rynhardt celebration Tags: Wayde and Rynhardt celebration

The achievements of Wayde van Niekerk and his
fellow Kovsie athlete, Rynardt van Rensburg,
at the Olympic Games, were celebrated during
a celebration ceremony for them on
15 September 2016 in the Callie Human Centre.
Photo: Johan Roux

The environment surrounding him has changed a lot over the past few weeks, but Wayde van Niekerk doesn’t see himself as superstar. The 400 m Olympic champion is embracing being back home and is feeling the love of the Kovsie family that helped him reach great heights.

“I see this (the Bloemfontein Campus) as a place where I can find peace,” the University of the Free State (UFS) athlete said at a celebration ceremony on 15 September 2016 for him and fellow Olympian, Rynardt van Rensburg. The event celebrated their achievements after participation in the Olympic Games in Rio de Janeiro, Brazil. Their coaches, Tannie Ans Botha and Derek van Rensburg, were also honoured.

Van Niekerk looks ahead
“I am always excited to get back home,” Van Niekerk said. Everybody who means something to him is in Bloemfontein and on this campus. “I thank you for believing in me. I am only 24 years old and still have quite a few years left to keep on doing what I do.” He also conducted the official opening of the new KovsieFit gymnasium in the Callie Human Centre.

According to Prof Nicky Morgan, acting Vice-Chancellor and Rector, the attendees had “Wayde fever”. “We can’t really say thank you enough – at least for the association we have had with you (Van Niekerk) over the years.”

Rynardt didn’t expect best in Rio

 “I see this (the Bloemfontein Campus)
as a place where I can find peace.”

Van Rensburg reached the semi-finals in Rio and ran a personal best of 1:45.33 in the 800 m. “If we don’t have support, we won’t be able to do this,” he said.
Although his form was improving prior to the Olympics, he didn’t expect to run a personal best. “My dad (and coach) kept believing in me and telling me it is possible to do.”

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