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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 research sheds light on service delivery protests in South Africa
2015-01-23

UFS research sheds light on service delivery protests in South Africa

Service delivery protests in the country have peaked during 2014, with 176 major service delivery protests staged against local government across South Africa.

A study by the University of the Free State (UFS) found that many of these protests are led by individuals who previously held key positions within the ANC and prominent community leaders. Many of these protests involved violence, and the destruction had a devastating impact on the communities involved.

This study was done by Dr Sethulego Matebesi, researcher and senior lecturer at the UFS. He focused his research on the dynamics of service delivery protests in South Africa.

Service delivery protests refer to the collective taken by a group of community members which are directed against a local municipality over poor or inadequate provision of basic services, and a wider spectrum of concerns including, for example, housing, infrastructural developments, and corruption.

These protests increased substantially from about 10 in 2004 to 111 in 2010, reaching unprecedented levels with 176 during 2014.

The causes of these protests are divided into three broad categories: systemic (maladministration, fraud, nepotism and corruption); structural (healthcare, poverty, unemployment and land issues); and governance (limited opportunities for civic participation, lack of accountability, weak leadership and the erosion of public confidence in leadership).

In his research, Dr Matebesi observed and studied protests in the Free State, Northern Cape and the North-West since 2008. He found that these protests can be divided into two groups, each with its own characteristics.

“On the one side you have highly fragmented residents’ groups that often use intimidation and violence in predominantly black communities. On the other side, there are highly structured ratepayers’ associations that primarily uses the withholding of municipal rates and taxes in predominantly white communities.”

 

Who are the typical protesters?

Dr Matebesi’s study results show that in most instances, protests in black areas are led by individuals who previously held key positions within the ANC - prominent community leaders. Generally, though, protests are supported by predominantly unemployed, young residents.

“However, judging by election results immediately after protests, the study revealed that the ANC is not losing votes over such actions.”

The study found that in the case of the structured ratepayers’ associations, the groups are led by different segments of the community, including professionals such as attorneys, accountants and even former municipal managers.

Dr Matebesi says that although many protests in black communities often turned out violent, protest leaders stated that they never planned to embark on violent protests.

“They claimed that is was often attitude (towards the protesters), reaction of the police and the lack of government’s interest in their grievances that sparked violence.”

Totally different to this is the form of peaceful protests that involves sanctioning. This requires restraint and coordination, which only a highly structured group can provide.

“The study demonstrates that the effects of service delivery protests have been tangible and visible in South Africa, with almost daily reports of violent confrontations with police, extensive damage to property, looting of businesses, and at times, the injuring or even killing of civilians. With the increase of violence, the space for building trust between the state and civil society is decreasing.”

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