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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

Getting out of the dark
2015-04-28

Photo: Leonie Bolleurs

Since 2008, the University of the Free State has been busy with the planning and implementation of projects to reduce the impact of load shedding. To date,  the cost of these projects has run to R6 million. They have been done primarily to ensure that the academic programme does not suffer damage as a result of the increasing interruptions in the power supply that are continuing this year.

The university’s greatest concern has been the provision of emergency power to the lecture halls and laboratories.

Thus far, 35 generators are servicing 55 buildings on the three campuses of the UFS. This includes 26 generators on the Bloemfontein Campus, eight on the Qwaqwa Campus in the Eastern Free State, and one generator on the South Campus in Bloemfontein. The generators are already in service, and are maintained in working order.

Since 2010, the university has also ensured that all newly-built academic buildings are equipped with emergency power supplies.

On the South Campus in Bloemfontein, the new lecture-hall building and the computer laboratory are equipped with emergency power, while the installation of emergency generators in other buildings is under way. The majority of the buildings on the Qwaqwa Campus in the Eastern Free State are equipped with emergency power supplies.

In the meantime, the UFS management has approved a further R11 million for the installation of additional generators on the three campuses. A further R1.5 million has also been approved for the purchase of two mobile generators.

To extend the work already done, the main task will be the installation of more generators on the Bloemfontein Campus to ensure that lecture halls with emergency power will be available for the centrally-arranged timetables, and to ensure that more of the critical laboratories will be provided with emergency power.

There are still  some important buildings and halls on the Bloemfontein Campus that must be supplied with emergency power. However, it is a costly process and must be brought into operation gradually. The further implementation of emergency power depends on the delivery of equipment. The university is also investigating alternative solutions for power provisioning, including solar power.

Generators with spare capacity are optimally deployed to satisfy the lower needs of the campus, including the Odeion, the ANNEX at Microbiology, the Stabilis ANNEX, the Agriculture Building, the UV-Sasol library, and the Francois Retief Building.

In addition, the UFS  is busy on all campuses, coupling area lighting, including

street lights and pedestrian walkways, to existing generators. Procedures for the operation of mechanical equipment, such as entrance gates, lifts, and so on, are currently being dealt with on all campuses. Continuous power sources for certain ICT equipment will be installed on all campuses to protect it against power surges.

Staff and students can also equip themselves with the necessary knowledge to manage load shedding in their specific areas of work and study. It is always helpful to know who to contact. The following list with guidelines and contact numbers has been compiled to assist you:

1. In an emergency, call Protection Services. This line will continue to operate, regardless of whether the power is on or off.
2. Avoid using lifts just before planned load shedding. Some lifts have emergency power packs which will bring the lift to the nearest floor and open the doors. If you still get stuck in a lift during a power outage, use your cellphone to call Protection Services. While you're waiting, stay calm and be patient.
3. If the access control systems in your building stop working after load shedding, contact Protection Services.
4. The students and staff members who are most at risk during load shedding are those in wheelchairs or with other mobility limitations. As far as possible, plan ahead to avoid being stuck on a floor or in a room that is difficult to access when load shedding is imminent. Please contact Protection Services if you need assistance.
5. During a fire, alarms WILL go off. Alarms are not power driven, but battery driven. For assistance, contact Protection Services.
6. The main UFS Switchboard (Bloemfontein Campus +27(0)51 401 9111 and Qwaqwa Campus +27(0)58 718 5000) will continue to operate during load shedding.

Contact details of Protection Services:

  • Bloemfontein Campus: +27(0)51 401 2634/2911
  • Qwaqwa Campus: +27(0)58 508 5460/5175
  • South Campus: +27(0)51 5051217

Communication and Brand Management will make information available on the UFS web, Facebook page, Twitter, Blackboard and the intranet. Get the load shedding schedule from Eskom’s webpage (http://loadshedding.eskom.co.za/). The Bloemfontein Campus falls in group 4 and the South Campus falls in group 2 in Centlec’s load shedding schedule.

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