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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

Bullying in schools: Everyone’s problem
2005-06-03

From left:  Prof Gerhardt de Klerk, Dean: Faculty of the Humanities; Prof Corene de Wet; Prof Rita Niemann, Head of the Department of Comparative Education and Educational Management in the School of Education and Prof Frederick Fourie, Rector and Vice-Chancellor of the UFS

It is not only learners who are the victums of bullying in schools, but also the teachers. Prof. Corene de Wet from the Department Comparative Education and Educational Management at the University of the Free State reported, against the background of two studies on bullying in Free State secondary schools, that bullying is a general phenomena in these schools.

Prof. de Wet, who delivered her inaugural lecture on Wednesday night, is from the Department Comparative Education and Educational Management which resorts under the School of Education at the University of the Free State. She is the first women who became a full professor the School of Education.

Prof. de Wet says, “A student is being bullied or victimized when he or she is exposed, repeatedly and over time, to negative action on the part of one or more students. Bullying always includes the intentional use of aggression, an unbalanced relationship of power between the bully and the victim, and the causing of physical pain and/or emotional misery.

In some Free State schools there are victims and perpetrators of direct and indirect verbal, as well as emotional, physical and sexual bullying.

“Adults who say that bullying are part of the growing-up process and parents who set not only academic expectations but also social expectations to their children cause that victims are unwilling to acknowledge that they are being bulled. Many parents are also unaware of the levels of bullying their children are exposed to.

“Some of the learners were at least once a month the victim of direct verbal harassment, 32,45% were assaulted by co-learners and 11,21% of them were at east once per week beat, kicked, pushed and hurt in any other physical way. Free State learners are very vulnerable to bullies at taxis and on the school yard they are mostly exposed to bullies in bathrooms.

“Learners are usually bullied by members of the same gender. However, racial composition also plays a role in some Free State schools. A grade 12 girl writes, ‘There are boys in my school who act means against black people. When the teacher is out they take a red pen and write on the projector and spray it with spirits. It looks like blood and they would say it is AIDS and my friends and I have it.’

“Educators must take note of bullying in schools and must not shrug it off as unimportant. Principals or educators could be find guilty of negligence. A large number of educator respondents, 88,29%, indicated that they would intervene in cases of verbal bullying and 89,71% would intervene if they saw learners being physically bullied. However, only 19,97% of the learners who were victims of bullying were helped by educators/ other adults from their respective schools.

“The learners’ lack of trust in their educators’ abilities and willingness to assist them in the fight against bullying has important implications for education institutions. The importance of training must be emphasised.

Learners bully their educators to undermine their confidence. In Prof. de Wet’s study on educator-targeted bullying in Free State schools 24,85% of the respondents were physically abused by their learners, 33,44% were the victims of indirect verbal bullying, and 18,1% were at one time or another sexually harassed by their learners. These learner offences may lead to suspension.

“Educators are not only victims of bullying; some of them are the bullies. The South African Council for Educators prohibits bullying by educators. It is worrying that 55,83% of the educators who participated in the research project verbally victimised learners, 50,31% physically assaulted learners and a small percentage was guilty of sexual harassment.

“Every educator and learner in South Africa has the right to life, equal protection and benefit of the law, of dignity, as well as of freedom and security of the person. These rights will only be realised in a bully-free school milieu.

“To oppose bullying a comprehensive anti-bullying programme, collective responsibility and the establishment of a caring culture at schools and in the community is necessary,” said Prof. de Wet.
 

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