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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 sets trend for higher education institutions
2005-09-21

The University of the Free State (UFS) offers more service-learning courses than any other higher education institution in the country and has the highest number of students enrolled for these service-learning courses.

This was the research findings on higher education institutions conducted between 2001 and 2004 by the Joint Education Trust (JET) into service-learning courses. These are courses which seek to integrate service to the community into the academic core of higher education institutions.

The results of this research indicated that the UFS is one of the few higher education institutions in South Africa that have made progress in integrating community engagement into the mainstream academy.

According to the findings 2 233 students at the UFS participated in service-learning courses supported by JET, while 858 students at the University of Transkei (UNITRA), 636 students at the University of the Western Cape (UWC) and only 600 students at the University of the Witwatersrand (WITS) participated in service-learning courses.

In total there were 6 930 students participating in service learning courses supported by the JET at 10 institutions throughout the country.

The research also found that out of a total of 182 service-learning courses supported by JET countrywide, the UFS had the highest number of such courses at 42, followed by WITS with 28, the University of Kwazulu Natal with 26, UWC 24 and UNITRA with 22.

Nationally, most of the service-learning courses at higher education institutions are offered in the human sciences (62), followed by health sciences (37), education (26), agriculture (14), and economic sciences (11).

According to leading academics, service-learning is a credit-bearing, educational exercise in which students participate in an organised service activity that meets identified community needs and helps the student to gain a deeper understanding of course content and a sense of civic responsibility.

Reacting to the research findings, the Rector and Vice-chancellor of the UFS, Prof Frederick Fourie, said the university feels strongly that there should be integration of service-learning into the academic core of the institution.

“Through service-learning modules the UFS can give expression to its role of service to the community as an institution of higher learning, producing quality graduates who understand the communities in which they will have to function for the rest of their lives,” Prof Fourie said.

According to Mr Jo Lazarus, the project manager of the Community-Higher Education – Service Partnership (CHESP), which falls under the JET, a number of institutions have identified community engagement as a strategic priority and have allocated significant resources from their central budget towards its implementation.

Mr Lazarus said most students have an overwhelmingly positive attitude towards service learning.

“A large percentage of students surveyed indicated that their service-learning course helped to improve their relationship skills, leadership skills and project planning abilities. As significant is the fact that these courses also benefited them in terms of their awareness of cultural differences and opened their eyes about their own cultural stereotypes,” said Mr Lazarus.

“The key challenge still hampering the integration of service-learning as a core function of academic activity is that some institutions still see service-learning as an add-on, and nice-to-have activity,” he said.

According to Mr Lazarus higher education must demonstrate social responsibility and commitment to the common good by making available expertise and infrastructure for service-learning as a form of community engagement.

Media release
Issued by:  Lacea Loader
   Media Representative
   Tel:  (051) 401-2584
   Cell:  083 645 2454
   E-mail:  loaderl.stg@mail.uovs.ac.za
   20 September 2005

 

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