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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

Statement on protest at the UFS
2005-03-04

Following a protest by student and non-student organisations today, the management of the University of the Free State (UFS) would like to place the following facts on record:

1. There is a well-documented process underway to further transform the UFS. At the official opening of the UFS on 4 February 2005 , the Rector and Vice-chancellor, Prof Frederick Fourie, announced that the UFS would draft a comprehensive Transformation Plan to guide the next phase of transformation at the institution.

The UFS appeals to student formations, staff associations, trade unions and other role-players to make a constructive input into this Transformation Plan.

The UFS management has been - and always will be - willing to engage with role-players and is prepared to do so even after today’s protest.

2. There is thus no regulation or policy prescription which separates students in hostels according to race.

The reality is that students exercise their freedom of choice as to which hostel they wish to be placed in. This was agreed upon by black and white students in 1997/8.

However, the unintended consequence and practice of this hostel placement policy has been that students themselves have tended to choose to stay in hostels which have over time become black hostels and white hostels.

This is a matter of concern for the management of the UFS as such a situation does not promote interaction across language, cultural and socio-economic groupings of students.

This matter is receiving attention and an intensive consultative process, which will include students, will be launched to review this policy.

The management is convinced that such interaction will enhance the learning experience of all students and sensitise them to the reality of a multicultural South Africa and a multicultural world.

3. No student organisation has been banned from operating at any of the three campuses of the UFS.

In the past few weeks, SASCO, the Young Communist League and the ANC Youth League (ANCYL) have held meetings on all three campuses, namely the Qwaqwa campus, the Vista campus and the main campus.

There are also regular interactions between top management and the leadership of SASCO and the ANCYL on campus.

In fact, the UFS upholds the right of students and staff to associate freely and to organise themselves as they see fit.

The UFS also upholds the rights of staff and students to engage in legal and peaceful protests.

The management however remains committed to discussing issues that affect staff and students in a constructive manner and appeals to student organisations in this case to engage with management.

4. The issues of registration, fees, debt and financial aid are continually monitored, and interventions to assist students are made regularly. To assist as far as possible those academically deserving students who face financial difficulties, the UFS management has put in place a structure called the Monitoring committee that includes management and student representatives.

The purpose of the Monitoring Committee is to review the cases of individual students to determine how best they can be assisted.

This applies to the Qwaqwa campus, the Vista campus and the main campus.

It is generally the case that students who perform academically will not have any difficulty in obtaining financial assistance. However, according to the requirements of National Student Financial Scheme, students who perform poorly will have difficulty in obtaining such assistance.

5. With regard to student governance, the process to institute an inclusive Central Student Representative Council (SRC), on which all three campuses will be equitably represented, was launched in July 2004, and a preliminary constitution has just been drafted. At the same time an inclusive process to review certain elements of the constitution of the main campus SRC was initiated at the end of 2004. This process, which includes all relevant student organisations and structures, is planned to produce an outcome within the next couple of months.

6. There is no policy at the UFS that is based on racism or that discriminates on the basis of the race of students and staff.

As part of the building of a new institutional culture within the broader transformation process, the UFS management is determined to eradicate all elements of racism that may occur on its campuses, and has already instituted inclusive forums on campus to discuss the issue of values and principles for a non-racial university.

Issued by: Mr Anton Fisher
Director: Strategic Communication
Cell: 072 207 8334
Tel: (051) 401-2749
4 March 2005

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