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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

Conversations of the untold tales of apartheid
2016-08-30

Description: Conversations of the untold tales of apartheid Tags: Conversations of the untold tales of apartheid

Prof Pumla Gobodo-Madikizela leading a dialogue
held at the Johannes Stegmann Art Gallery with
guest speakers, Candice Mama, Siyah Mgoduka,
and Sue Williamson.

Photo: Johan Roux

The Vice-Chancellor’s Lecture Series on Trauma, Memory and Representations of the Past in  the Unit for Trauma, Forgiveness and Reconciliation Studies at the University of the Free State (UFS) hosted a dialogue between students and guest speakers, Sue Williamson, Candice Mama, and Siyah Mgoduka at the Johannes Stegmann Art Gallery on the Bloemfontein campus.

The conversation, led by Prof Pumla Gobodo-Madikizela, Senior Research Professor in Trauma, Forgiveness and Reconciliation Studies at the UFS, touched on students’ direct historical trauma and memory experiences, allowing them to share their contribution to transformation.

Mama and Mgoduka shared their personal experience of how the negative impact apartheid’s fatal events consumed their everyday life. Both their fathers were killed by the apartheid assassin, Eugene de Kock, whom they have met and with whom they have since been reconciled.  Reflecting on this historical memory, both of them agree that meeting their fathers’ killer has changed their lives.

“Forgiveness is a personal journey one
takes in order to let go of bitterness and hate.” 

“Before meeting De Kock, I was bitter, angry, and full of hatred towards him. After that meeting, I became a better person and more engaged, and stopped stereotyping white people,” says Mama.

Mgoduka says, “Forgiveness alone will not work. There needs to be an interest in each other as black and white.”

The dialogue followed the launch of Williamson’s art exhibition, No More Fairytales, held at the Johannes Stegmann Gallery on 18 August 2016. Through a series of interactive pieces, the artwork captures events that led to the role of the Truth and Reconciliation Commission (TRC).

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