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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

UFS gets equipment worth R3,9 million to do doping tests for the World Cup
2010-05-18

One of the new state-of-the-art machines to be used for dope testing.
Photo: Mangaliso Radebe


The South African Doping Control Laboratory (SADoCoL) at the University of the Free State (UFS) in Bloemfontein boasts new state-of-the-art equipment worth R3,9 million with which doping tests for next month’s 2010 FIFA World Cup will be done.

“Our new instruments are some of the best in the world,” said a proud Dr Pieter van der Merwe, Head of the laboratory.

SADoCoL, housed in the Department of Pharmacology at the UFS, has done doping analyses for many international sport events in South Africa and elsewhere in the world, including the 1995 Rugby World Cup and the Sevens Rugby World Cup in Dubai.

“Because of our international recognition and accreditation by the World Anti-Doping Agency (WADA) the laboratory was selected to be the official doping control facility of the 2010 FIFA World Cup,” he said.

“FIFA has entered into a contract with us and they will send all the urine and blood samples for the World Cup to this laboratory. I must hasten to say that it is not only for the World Cup. We will continue with the work that we have been doing all these years regarding doping analysis in South Africa.”

“It is an honour for the Department and the UFS to offer a world-class service to a world-class association like FIFA and to be associated with a tournament of this magnitude.”

Being the only one of its kind in South Africa, and one of only two in Africa (the other being in Tunisia), it is not surprising that FIFA has entered into this partnership with SADoCoL.

“It is a well-known fact that we have been, and still are, the official doping control testing facility in South Africa for many years now. So there is also a lot of African involvement in our laboratory where African countries send samples to us for analysis,” he said.

It is not for the first time, though, that SADoCoL is involved with FIFA. The laboratory did all the testing for the Confederations Cup that was held in South Africa in June 2009.

It had just been extended to accommodate the new equipment. An official viewing session of the new facility was held last week.

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt@ufs.ac.za  
18 May 2010
 

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