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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

You touch a woman, you strike a rock
2004-11-02

Prof. Engela Pretorius van die Departement Sosiologie in die Fakulteit Geesteswetenskappe by die Universiteit van die Vrystaat het die kwessie omtrent feminisme aangespreek tydens haar intreerede met die onderwerp, You touch a woman, you strike a rock: Feminism(s) and emancipation in South Africa .

Prof. Pretorius het gesê: “Die geskiedenis van feminisme oor die algemeen kan in drie fases verdeel word, waarna verwys word as golwe. Eerste-golf-feminisme (19de eeu) het die fokus geplaas op die beskerming van vroueregte in die openbare terrein, spesifiek die reg om te stem, die reg tot onderrig en die reg om middelklas beroepe en professies te betreë.

Vroeë tweede-golf-feminisme word onthou vir hoe dit moederskap geteoretiseer het as synde ‘n onderdrukkende instelling. Slagspreuke van die 1970s was die persoonlike is polities en susterskap is magtig. Prof. Pretorius sê beide slagspreuke bevestig die idee dat vroue universeel onderdruk en uitgebuit word en slegs deur erkenning van dié situasie kan vroue die strukture wat hul onderdruk verander.

‘n Belangrike aspek van die derde golf van die feminisme-teorie is post-moderne feminisme wat diversiteit en verskille onderstreep. Die poging van hierdie feministe is afgestem op alle vorme van onderdrukking. Vroue van kleur het ook hul ontevredenheid uitgespreek gedurende die derde-golf-feminisme. Die feminisme van vroue van kleur word gekenmerk deur verskeie kwessies en talryke intellektuele standpuntinnames wat neerslaga vind in verskillende terme, soos Afrika feminisme of ‘womanism, sê prof. Pretorius.

Afrika-feminisme dui protes aan teen die wit/westerse geskiedenis en die wit/westerse dominansie binne feminisme. Afrika-vroue het besef dat hul onderdrukking verskillend is van dié van wit vroue en daarom is ‘n ander proses van bevryding nodig. Die Westerse feministiese praktyk om swart vroue by die bestaande feministiese ontologie te voeg, is nie voldoende nie omdat hul unieke ondervindings van slawerny, kolonialisme, onderdrukking deur mans en armoede nie uitgedruk word nie.

‘Womanism’ het tot stand gekom as gevolg van ‘n eksplisiete rassekritiek teen feminisme. Dit is ten gunste van die positiewe uitbeelding van swart mense. Dit word gekenmerk deur kulturele kontekstualisasie, die sentraliteit van die gesin en die belangrikheid daarvan om mans in te sluit.

Die geskiedenis van vroue in Suid-Afrika is verwant aan hul geskiedenis van onderdrukking as gevolg van patriargie. Vroue van verskillende rasse, kulture en klasse het patriargie op verskillende wyses in en variërende mate van erns ervaar. Onder voor-koloniale patriargie het vroue min sê gehad oor huwelikskeuses omdat mans dié besluite gedomineer het.

Die Nederlandse en Britse patriargale erfenis het neerslag gevind in die ideologie van die volksmoeder. Onderwyl dit veral manlike skrywers was wat die beeld van die vrou as versorger en tuisteskepper bevorder het, het vroue self ook hieraan ‘n aandeel gehad, sodat die volksmoeder volwaardig deel geword het van die Afrikaner nasionalistiese mitologie. Alhoewel middel- en werkersklas vroue met dié beeld geïdentifiseer het, het nie alle Afrikaanse vroue die ideologie aanvaar nie.

Onder die Victoriaanse erfenis was Britse vroue beperk to die private eerder as die openbare lewe. Die skeefgetrekte onderrigsisteem wat vroue in huishoudelike loopbane gekanaliseer het, die mag van mans oor hul vroue se eiendom en ‘n tekort aan toegang tot mag en geld het verseker dat vroue by die huis gebly het.

Wit Engelssprekende-vroue het die grootste geleentheid gehad om patriargie uit te daag vanweë hul toegang tot onderwys en die blootstelling aan liberale waardes, sê prof. Pretorius. Liberale vroue soos Helen Joseph en Helen Suzman het ‘n belangrike rol gespeel om in 1930 stemreg vir wit vroue in Suid-Afrika te verseker en het voortgegaan om ‘n rol te speel in die bevryding van swart vroue gedurende die vryheidstryd.

Die feminisme wat onder swart vroue ontwikkel het, was ‘n erkenning van die gemeenskaplike stryd met swart mans om die verwydering van die juk van eksterne onderdrukking en eksploitasie. Swart vroue in aktiewe en onafhanlike politiese rolle het tegelykertyd mans se aannames omtrent hul meerderwaardigheid asook die rassewette van die staat uitgedaag. Daarom kan ons sê dat die feminisme wat hier ontwikkel het, te voorskyn gekom het as gevolg van vroue se betrokkenheid by en toewyding tot nasionale bevryding, sê prof. Pretorius.

Institusionalisering is nie herlei tot magsvoordele nie, want gelykheid is nie in beleidsprogramme geïnkorporeer nie. Die hervestiging van sleutel aktiviste van die vrouebeweging in die regering het die stryd om genderbillikheid verander na ‘n projek wat deur die regering gelei word, sê prof. Pretorius. Ongelukkig word terreine van verandering buite die grense van die regering verwaarloos. Dit kan slegs aangespreek word deur ‘n aktiewe en feministiese stem in die burgerlike samelewing.

“Dit is my oortuiging dat formele instellings vir vroue binne die staat oor die lang termyn slegs effektief kan wees indien daar ‘n effektiewe feministiese vroue-beweging buite die staat in stand gehou word wat die grondslag waarop sosiale beleid gevorm word, kan uitdaag en bevraagteken. Daarom, A luta continua (die stryd duur voort),” sê prof. Pretorius.

Mediaverklaring
Uitgereik deur: Lacea Loader
Mediaverteenwoordiger
Tel: (051) 401-2584
Sel: 083 645 2454
E-pos: loaderl.stg@mail.uovs.ac.za
2 November 2004

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