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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

Inaugural lecture: Prof André Pelser
2004-06-04

Tendencies and changes in the South African population structure in future decades.

Within the next five years South Africa will for the first time in the past century enter a period where the death rate will exceed the birth rate, largely due to the impact of HIV / AIDS.

According to sociologist Prof André Pelser, sociologist at the of the University of the Free State’s (UFS) Department of Sociology, the death rate exceeding the birthrate is only one of three demographic trends which will fundamentally change South Africa’s population structure in the following decades.

He was speaking at the UFS in Bloemfontein during his inaugural lecture as professor this week.

Prof Pelser said that according to some models the South African population will decrease within the next five decades by between 10 and 26 percent.

A second important trend which will impact on the population structure is the progressive ageing of the population.

He said the group above 65 years is the only age category in the South African population which will witness sharp increases in the next few decades.

In the next 50 years, the group younger than 15 years will reflect a decrease of 39% and those older than 65 years in South Africa will increase by approximately 110% in the next two decades.

“The systematic “greying” of the South African population will create the same economic and welfare issues as those with which governments in some more developed countries are already grappling,” said Prof Pelser.

A third trend affecting the South African population structure is the constant decrease in life expectancy.

Life expectancy at birth for the total population is projected to decrease from approximately 62 years at the beginning of the 1990’s to 43 years in 2015-2020, with sharp differences between the various population groups.

These tendencies and changes to the South African population structure have serious implications, he said.

For example, he said, the reduction in life expectancy could compromise national development objectives.

“It is estimated that more than a quarter of the economically active population will be infected with HIV by 2006,” said Prof Pelser.

The increase in the population, in age category 65, will place a financial burden on government and the economically active sector.

“Especially worrying is the fact that ever-increasing proportions of the state budget will be allocated to health and welfare services and this at the expense of other priorities like education, infrastructure, criminal justice system and trade and industry, to name but a few,” he said

“A comprehensive and integrated strategy is thus vitally important in addressing the overarching issues caused by changes in the population structure,” said Prof Pelser.

 

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