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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

SA cannot sustain momentum - Boesak
2010-09-02

Photo: Stephen Collett

South Africa finds it increasingly difficult to live up to the challenges facing it as a nation because of its failure to meet its democratic ideals and possibilities, peace and lack of self-belief.

This was according to renowned cleric and former political activist, Dr Allan Boesak, who recently delivered the CR Swart Memorial Lecture, the oldest memorial lecture at the University of the Free State (UFS). His lecture was on the topic Creating moments, sustaining momentum.

He said South Africa had plenty of opportunities to show the whole world what was possible if all the people of this country joined hands and worked together to build a truly united society. However, he said, the country somehow invariably contrived to find its way out of these wonderful possibilities.

He cited events of historical significance like Codesa, the inauguration of Nelson Mandela as the first democratic president of South Africa, the assassination of South African Communist Party leader, Chris Hani; and the rugby and soccer world cups.
To drive his point home about this dismal failure of the country to “sustain momentum”, he alluded to the current public servants’ strike that is gradually crippling public service.

“The public servants’ strike was neither unexpected nor is it completely unjustifiable. Most of us have understanding for the frustration of teachers and health workers. Their demands resonate with most of us, and I think that it is scandalous of SACP fat cats to tell workers to “stop crying like babies,” he said.

He also added to the criticism of the much-maligned decision of the government to spend billions of taxpayers’ money to purchase weapons when there was “no discernible military threat” to the country. He said the greatest threat to the security of the country was poverty, inequality and social cohesion.

“As for the argument that arms sales bring in foreign exchange – how can we be instrumental in killing the poor elsewhere with the intention of feeding our poor, and then our ill-gained profits feed only the already well-fed?” he asked.
“Can we see the hopeless contradiction, the total impossibility of being both the apostle of peace and a merchant of death?”

He also lambasted the Black Economic Empowerment (BEE) policy of the government which he said benefited only those connected to the political aristocracy.

“It couples with the unashamed, in-your-face display of wealth by the privileged elite in this country, the crass materialism of the so-called “bling generation”, and the casual carelessness with which promises to the poor are given and treated. It is only the public symptom of the deep-seated scorn our political elites feel for the poor,” he said.

He said the government’s disdain to the poor was “setting fire to our future”.

“The anger of people on the ground can no longer be denied or ignored, and little by little, the leadership articulating and directing this anger is being estranged from politically elected leadership, and even more disturbing, from our democratic processes,” he said.

He concluded that the country’s difficulty in dealing with race and racism was putting the reconciliation process kick-started by Mandela just over a decade ago, under a threat.
 

 

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