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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 breakthrough on SRC
2005-06-10

The Council of the University of the Free State (UFS) today unanimously approved the establishment of a Central Student Representative Council (CSRC)  to ensure the democratic participation of students at its three campuses in the governance of the university.

In a major breakthrough and transformation step for student governance, the Central SRC will include representatives of the main campus in Bloemfontein, the Vista campus and the Qwaqwa campus of the UFS.

The establishment of the Central SRC follows the incorporation of the Qwaqwa campus into the UFS in January 2003 and the incorporation of the Vista campus in Bloemfontein into the UFS in January 2004.

According to Dr Ezekiel Moraka, Vice-Rector: Student Affairs, today’s decision of Council is the result of a lengthy, negotiated agreement between the three campuses. Independent experts facilitated part of the process.

With the establishment of a Central SRC, the UFS has adopted a federal student governance model whereby the CSRC is the highest representative student body on matters of common concern for all students.

However, the three campuses of the UFS will retain autonomous SRC structures for each campus with powers and responsibilities for matters affecting the particular campus.

This arrangement will be reviewed after a year to make allowance for the phasing out of students at the Vista campus, as was agreed in the negotiations preceding the incorporation of that campus into the UFS.

The central SRC will have a maximum of 12 members made up of members of the campus SRCs, including the presidents of these three SRCs. In total, the main campus will have 5 representatives, the Qwaqwa campus will have 4 representatives and the Vista campus will have 3 representatives.

From these 12 members a central SRC president will be chosen on a quarterly basis to represent the general student body at Executive Management, Senate and Council.

In another key decision and significant step forward affecting student governance, the Council also approved amendments the constitution of the Student Representative Council (SRC) of the main campus.  These amendments were the results of deliberations of student organizations, the SRC and the Student Parliament of the UFS main campus.

The amendments to the constitution of the main campus SRC determines that nine of the 18 SRC members must be elected by means of proportional representation and nine on the basis of an individual, first-past-the-post election.

This decision comes in the wake of calls by certain student organizations on main campus for proportional representation to be included as a means of electing student representatives.

The following portfolios of the main campus SRC will be contested by individual candidates on the basis of first past the post:

  • president
  • secretary
  • academic affairs
  • legal and constitutional affairs
  • student development
  • arts and culture
  • men’s internal liaison
  • ladies internal liaison
  • media, marketing and liaison

The following nine portfolios will be contested by affiliated organizations on a proportional representation basis.

  • two vice-presidents
  • treasurerdialogue and associations
  • transformation
  • campus affairs and recreation
  • sport
  • international affairs
  • community service

It also is a breakthrough to have all constitutional changes processed and approved at the June meeting of the Council, with all relevant student organizations having been part of the process and accepting the outcome of the process.

According to the chairperson of the UFS Council, Judge Faan Hancke, today’s unanimous decisions on student governance are an indication of how all UFS stakeholders represented in Council are committed to finding win-win solutions in the interest of the university.

“Once again the UFS has reached another milestone in its transformation and has shown the rest of the country that we are pioneers in the field of reaching intelligent solutions to complex situations,” Judge Hancke said.

According to Dr Moraka, the central SRC constitution will come into effect from the start of the second semester this year.

 MEDIA RELEASE

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

10 June 2005
 

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