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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 policies want to help all students
2005-03-09

The death of Hannes van Rensburg, a first-year student from the JBM Hertzog residence, this past weekend, placed various aspects of student life in the spotlight.  Dr Natie Luyt, Dean:  Student Affairs at the University of the Free State (UFS), and the Student Representative Council (SRC) of the UFS explain which policies are in place to counter these practices.

At all tertiary institutions there are rules and policies to guide students and provide direction for certain behaviour and practices.  The same applies to the University of the Free State (UFS).

“At the beginning of the year the UFS provides every residence committee with a manual to establish a framework for meaningful and orderly relations within and among residences on the campus,” said Dr Natie Luyt.

However, it is one thing to set rules, but it is an impossible task to enforce all aspects thereof.  Policies currently in place include an alcohol policy, a policy on the induction of first years and a policy on banned practices in residence orientation. 

“The alcohol policy was compiled in cooperation with students and their input was constantly asked,” said Dr Luyt.  We also liaise on a continuous basis with residences and senior students to encourage the responsible use of alcohol, especially around activities like intervarsities and Rag. 

In the policy, recognition is given to the right and voluntary and informed choice of every individual to use alcohol on the UFS campus in a responsible way. 

Guidelines for the use of alcohol on campus include among others the following: 

Only authorised points of sale will be permitted on campus.  In this case it is the various league halls in most of the male residences on campus.

Alcohol will only be made available during fixed times and is not permitted in residence rooms.    

All alcohol-related functions are regulated and an application for a temporary alcohol license must be obtained from the Dean:  Student Affairs.     

The UFS obtained a liquor license in March 2004 which must be administered by senior leagues in various residences on campus.   Normal liquor license conditions and the county’s liquor laws apply.  Liquor can only be sold to members of the senior league (or special guests) and also to persons over the age of 18 years.  Liquor may not be used in public (outside the senior league) or on campus.    

The senior leagues may only be open three nights per week and within prescribed times.  No liquor could be used in any other place than the senior league halls.  Senior leagues could buy liquor from club monies generated by themselves. 

The right of senior leagues to serve liquor was suspended by the Rector and Vice-Chancellor the UFS, Prof Frederick Fourie, on Monday 7 March 2005 – pending an investigation of the recent events on campus. 

The policy on banned practices include among others that no swearing and shouting at first-years may take place, no first-year student may be targeted individually, no senior may enter the room of a first-year student without an invitation or permission from that first-year student and no senior under the influence of alcohol may have contact with first-year students. 

The induction of first-year students takes place by means of three functions, namely an information function (the introduction to the various facets and possibilities of the university system), an induction function (the first-year student becomes involved in various campus and residence activities) and a development function (the first-year student is motivated to take charge of his development potential). 

No first-year induction activity may commence before the residence committee’s contracting with the senior students is not completed.  This meeting is attended by the residence head and all senior students.  The induction policy, residence induction policy of first-year students and first-year rules are discussed.

The senior students sign an attendance list to show that he/she was informed about the policies.  A senior who does not sign, may not be involved with any induction session with first-year students.  

No physical contact is allowed during the conclusion of the first-year students’ official induction period.  The induction of first-year students as full members of the residence is a prestige event, presented by the residence committee.  No physical or degrading activities may take place. 

The Dean:  Student Affairs also has a daily meeting with the primarii of all the residences during the induction period.  This helps to monitor the situation and counter any problem behaviour or tendencies.

“Enforced behaviour – where a senior student forces a first-year student to do something against his/her own free wil – is not allowed.  Where there is any sign of this, it is met wortel en tak uitgeroei,” said Dr Luyt.

“In any group of people – whether it is a group of students or people at a workplace – there will always be those who will break the rules or those who would like to see how far they could push it.

The SRC, the UFS management and myself are and will stay committed to make each student’s life on this campus a school of learning and an experience which would be remembered for ever,” said Dr Luyt.

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