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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

Prof Antjie Krog speaks on verbalising revulsion and the collusion of men
2015-06-26

From the left are Prof Lucius Botes, UFS: Dean of the Faculty of the Humanities; Prof Helene Strauss, UFS: Department of English; Prof Pumla Gobodo-Madikizela, UFS: Trauma, Forgiveness and Reconciliation Studies; Prof Antjie Krog, UCT: Department Afrikaans and Dutch; Dr Buhle Zuma, UCT: Department of Psychology. Both Prof Strauss and Dr Zuma are partners in the Mellon Foundation research project.

“This is one of the bitterest moments I have ever endured. I would rather see my daughter carried away as a corpse than see her raped like this.”

This is one of 32 testimonies that were locked away quietly in 1902. These documents, part of the NC Havenga collection, contain the testimonies of Afrikaner women describing their experiences of sexual assault and rape at the hands of British soldiers during the South African War.

This cluster of affidavits formed the foundation of a public lecture that Prof Antjie Krog delivered at the University of the Free State’s (UFS) Bloemfontein Campus on Tuesday 23 June 2015. The lecture, entitled ‘They Couldn’t Achieve their Goal with Me: Narrating Rape during the South African War’, was the third instalment in the Vice-Chancellor’s Lecture Series on Trauma, Memory, and Representations of the Past. The series is hosted by Prof Pumla Gobodo-Madikizela, Senior Research Professor in Trauma, Forgiveness, and Reconciliation Studies at the UFS, as part of a five-year research project funded by the Andrew W. Mellon Foundation.

Verbalising revulsion

The testimonies were taken down during the last two months of the war, and “some of the women still had marks and bruises on their bodies as evidence,” Prof Krog said. The victims’ words, on the other hand, struggled to express the story their bodies told.

What are the nouns for that which one sees? What words are permissible in front of men? How does one process revulsion verbally? These are the barriers the victims – raised with Victorian reserve – faced while trying to express their trauma, Prof Krog explained.

The collusion of men

When the war ended, there was a massive drive to reconcile the Boers and the British. “Within this process of letting bygones be bygones,” Prof Krog said, “affidavits of severe violations by white men had no place. Through the collusion of men, prioritising reconciliation between two white male hierarchies, these affidavits were shelved, and, finally, had to suffer an embargo.”

“It is only when South Africa accepted a constitution based on equality and safety from violence,” Prof Krog said, “that the various levels of deeply-rooted brutality, violence, and devastation of men against the vulnerable in society seemed to burst like an evil boil into the open, leaving South African aghast in its toxic suppurations. As if, for many decades, we did not know it was there and multiplied.”

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