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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

Time is running out for applications for admission at the UFS
2009-11-25

The University of the Free State (UFS) calls on all South African prospective students wishing to study at the UFS in 2010 to submit their applications for admission by no later than 30 November 2009.

The last date for all international students’ applications for 2010 admission was 30 September 2009. All applications received from South African students after the closing date will be considered as late applications and will be handled in a separate process.

Late applications from prospective students will be accepted until 15 January 2010 to accommodate Grade 12 learners who will only receive their results on 7 January 2010.

All South African prospective students who want to apply must pay a non-refundable fee of R150. The duly completed and signed application form must be accompanied by a certified copy of the prospective student’s identity document or passport and a proof of payment of the application fee. The application form of a minor must be signed by his/her parent or guardian. The field of study should be clearly indicated.

The registration of first-time entering first-year students on the Main Campus will be from 19-23 January 2010 in the Callie Human Centre according to a programme.
The registration of senior undergraduate students (that is all students registered at the UFS up until 2009) and postgraduate students will take place from 5-16 January 2010 on a self-service system on the university’s website at www.ufs.ac.za   .

Academic advice for all students during the registration period will be available in the Callie Human Centre and the Multi-Purposes Hall, as well as from the different faculties.
First-time entering first-year students on the Main Campus will be welcomed by the Rector and Vice-Chancellor of the UFS, Prof. Jonathan Jansen, on Friday, 8 January and Saturday, 9 January 2010, at 09:00 in the Callie Human Centre.

At the Qwaqwa Campus late applications will be accepted until 3 February 2010.

The registration of first-time entering first-year and senior students at this campus will be from 18-22 January 2010 in the Multi-Purpose Hall, also according to a programme. First-time entering first-year students will be welcomed on 11 January 2010.

Lectures for all students will commence on 25 January 2010 on both campuses.

Media release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@ufs.ac.za  
24 November 2009

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