Latest News Archive

Please select Category, Year, and then Month to display items
Previous Archive
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

Inaugural lecture: Prof. Annette Wilkinson
2008-04-16

A strong plea for a pursuit of “scholarship” in higher education

Prof. Annette Wilkinson of the Centre for Higher Education Studies and Development in the Faculty of the Humanities at the University of the Free State (UFS) made as strong plea for a pursuit of “scholarship” in higher education.

She said in her inaugural lecture that higher education has to deal with changes and demands that necessitate innovative approaches and creative thinking when it concerns effective teaching and learning in a challenging and demanding higher education environment. She referred to a recent research report prepared for the Council for Higher Education (CHE) which spells out the alarming situation regarding attrition rates and graduation output in South African higher education and emphasises factors leading to the situation. These factors include socio-economic conditions and shortcomings in the school and the subsequent under preparedness of a very large proportion of the current student population. However, what is regarded as one of the key factors within the sector’s control is the implementation of strategies for improving graduate output.

She said: “The CHE report expresses concern about academics’ adherence to traditional teaching practices at institutions, which have not changed significantly to make provision for the dramatic increase in diversity since the 1980s.

“Raising the profile of teaching and learning in terms of accountability, recognition and scholarship is essential for successful capacity-building,” she said. “The notion of scholarship, however, brings to the minds of many academics the burden of ‘publish or perish’. In many instances, the pressures to be research-active are draining the value put on teaching. Institutions demand that staff produce research outputs in order to qualify for any of the so-called three Rs – resources, rewards and recognition.

“These have been abundant for research, but scarce when it comes to teaching – with the status of the latter just not on the same level as that of research. From within their demanding teaching environments many lecturers just feel they do not have the time to spend on research because of heavy workloads, that their efforts are under-valued and that they have to strive on the basis of intrinsic rewards.”

She said: “It is an unfortunate situation that educational expertise, in particular on disciplinary level, is not valued, even though in most courses, as in the Programme in Higher Education Studies at the UFS, all applications, whether in assignments, projects or learning material design, are directly applied to the disciplinary context. We work in a challenging environment where the important task of preparing students for tomorrow requires advanced disciplinary together with pedagogical knowledge.”

Prof. Wilkinson argued that a pursuit of the scholarship of teaching and learning holds the potential of not only improving teaching and learning and consequently success rates of students, but also of raising the status of teaching and recognising the immense inputs of lecturers who excel in a very demanding environment. She emphasised that not all teaching staff will progress to the scholarship level or are interested in such an endeavour. She therefore suggested a model in which performance in the area of teaching and learning can be recognised, rewarded and equally valued on three distinct levels, namely the levels of excellence, expertise and scholarship. An important feature of the model is that staff in managerial, administrative and support posts can also be rewarded for their contributions on the different levels for all teaching related work.

Prof. Wilkinson also emphasised the responsibility or rather, accountability, of institutions as a whole, as well as individual staff members, in providing an environment and infrastructure where students can develop to their full potential. She said that in this environment the development of the proficiency of staff members towards the levels of excellence, expertise and scholarship must be regarded as a priority.

“If we want to improve students’ success rates the institution should not be satisfied with the involvement in professional development opportunities by a small minority, but should set it as a requirement for all teaching staff, in particular on entry into the profession and for promotion purposes. An innovative approach towards a system of continuous professional development, valued and sought after, should be considered and built into the institutional performance management system.”

As an example of what can be achieved, Prof. Wilkinson highlighted the work of one of the most successful student support programmes at the UFS, namely the Career Preparation Programme (CPP), implemented fourteen years ago, bringing opportunities to thousands of students without matric exemption. The programme is characterised by dedicated staff, a challenging resource-based approach and foundational courses addressing various forms of under preparedness. Since 1993 3 422 students gained entry into UFS degree programmes after successfully completing the CPP; since 1996 1 014 of these students obtained their degrees, 95 got their honours degrees, 18 their master’s degrees and six successfully completed their studies as medical doctors.

Prof. Wilkinson said: “I believe we have the structures and the potential to become a leading teaching-learning university and region, where excellence, expertise and scholarship are recognised, honoured and rewarded.”

 

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept