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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

Census 2011 overshadowed by vuvuzela announcements
2012-11-20

Mike Schüssler, economist
Photo: Hannes Pieterse
15 November 2012

Census 2011 contains good statistics but these are overshadowed by vuvuzela announcements and a selective approach, economist Mike Schüssler said at a presentation at the UFS.

“Why highlight one inequality and not another success factor? Is Government that negative about itself?” Mr Schüssler, owner of Economist.co.za, asked.

“Why is all the good news such as home ownership, water, lights, cars, cellphones, etc. put on the back burner? For example, we have more rooms than people in our primary residence. Data shows that a third of Africans have a second home. Why are some statistics that are racially based not made available, e.g. orphans? So are “bad” statistics not always presented?”

He highlighted statistics that did not get the necessary attention in the media. One such statistic is that black South Africans earn 46% of all income compared to 39% of whites. The census also showed that black South Africans fully own nearly ten times the amount of houses that whites do. Another statistic is that black South Africans are the only population group to have a younger median age. “This is against worldwide trends and in all likelihood has to do with AIDS. It is killing black South Africans more than other race groups.”

Mr Schüssler also gave insight into education. He said education does count when earnings are taken into account. “I could easily say that the average degree earns nearly five times more than a matric and the average matric earns twice the pay of a grade 11.”

He also mentioned that people lie in surveys. On the expenditure side he said, “People apparently do not admit that they gamble or drink or smoke when asked. They also do not eat out but when looking at industry and sector sales, this is exposed and the CPI is, for example, reweighted. They forget their food expenditure and brag about their cars. They seemingly spend massively on houses but little on maintenance. They spend more than they earn.”

“On income, the lie is that people forget or do not know the difference between gross and net salaries. People forget garnishee orders, loan repayments and certainly do not have an idea what companies pay on their behalf to pensions and medical aid. People want to keep getting social grants so they are more motivated to forget income. People are scared of taxes too so they lower income when asked. They spend more than they earn in many categories.”

On household assets Mr Schüssler said South Africans are asset rich but income poor. Over 8,3 million black African families stay in brick or concrete houses out of a total of 11,2 million total. About 4,9 million black families own their own home fully while only 502 000 whites do (fully paid off or nearly ten times more black families own their own homes fully). Just over 880 000 black South Africans are paying off their homes while 518 000 white families are.

Other interesting statistics are that 13,2 million people work, 22,5 million have bank accounts, 19,6 million have credit records. Thirty percent of households have cars, 90% of households have cellphones and 80% of households have TVs.
 

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