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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

Exciting open day and Albert Einstein program at Boyden Observatory
2005-05-06

National Science Week, which will be held from 7-14 May 2005, is an annual country-wide celebration of science, led by the Department of Science and Technology.  The department selected a proposal by the Boyden Science Centre to coordinate a week of activities in the Bloemfontein area as one of the many projects in the country.

The project for Bloemfontein and surrounding areas will be delivered though a collaboration between the National Museum in Bloemfontein and the University of the Free State (UFS), including the Research Institute for Education Planning, the Department of Physics and other departments in the Faculty of Natural and Agricultural Sciences.

The purpose of National Science Week is:

to create awareness of the important role that science play in people’s daily lives;
to encourage our youth to consider studying and improving their performance in mathematics and science; and
to attract more of our youth into science, engineering and technology (SET) careers.

 

World Year of Physics and Albert Einstein Program at Boyden Observatory

The International Union of Pure and Applied Physics (IUPAP) declared the year 2005 as the World Year of Physics (WYP). In recognition of this declaration, the great contribution of Physics to the development of technology, and its importance in our everyday lives will be featured strongly during the National Science Week 2005.

On Saturday 7 May 2005 there will be a public programme at Boyden Observatory from 15:30 as a contribution to the World Year of Physics. The programme will be presented in collaboration with the Bloemfontein branch of the Astronomical Society of Southern Africa and will include short presentations on astronomy, space exploration and the sun.

The main presentation will be at 19:00 the evening on the life and work of Albert Einstein. The programme will also include observing sessions through telescopes of objects like the sun, Jupiter and Saturn. There will also be an exhibit on Albert Einstein. Attendance is free but booking is required.  For bookings, phone 051-4012561.

Public lecture programme:

Next week the following exciting public lectures will be presented as part of the Science Week activities:

Monday 9 May 2005 

National Museum:

A discussion on Apocalypse Then: the greatest mass extinction of all time.  The lecture will be presented by Dr Jennifer Botha, Paleontologist at the National Museum.
Bookings: 051-4479609 (entrance is free).

UFS campus:

All lectures at Kine 2, Medical Faculty, UFS campus. Follow directions from the DF Malherbe Road entrance.
Bookings: 051-4012561 (entrance is free).

Tuesday 10 May 2005:

A discussion on the Tsunami disaster of 26 December 2004 at 19:30 (UFS campus, Kine 2 Medical Faculty).

Wednesday 11 May 2005:

A discussion on Is there life out there? at 19:30 (UFS campus, Kine 2 Medical Faculty).

Friday 13 May 2005:

A discussion on Hunting Black Holes at 19:30 (UFS campus, Kine 2 Medical Faculty).  The lecture will be presented by Dr Phil Charles, Director: South African Astronomical Observatory.

Science awareness day at the National museum

The science week will be concluded on Saturday 14 May 2005 with a special Science Awareness Day at the National Museum, Aliwal Street, Bloemfontein. 

The excellent exhibits at the museum will be supplemented with activities, career information and video shows. The duration of the programme will be from 10:00-16:00.  For enquiries, please call 051-4479609.

 

Issued by:  Lacea Loader
   Media Representative
   Tel:  (051) 401-2584
   Cell:  083 645 2454
   E-mail:  loaderl.stg@mail.uovs.ac.za

6 May 2005
 

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