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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

Higher than expected prevalence of dementia in South African urban black population
2010-09-22

 Prof. Malan Heyns and Mr Rikus van der Poel

Pilot research done by University of the Free State (UFS) indicates that the prevalence of dementia, of which Alzheimer’s disease is only one of the causes, is considerably higher than initially estimated. Clinical tests are now underway to confirm these preliminary findings.

To date it has been incorrectly assumed that dementia is less prevalent among urban black communities. This assumption is strongly disputed by the findings of the current study, which indicates a preliminary prevalence rate of approximately 6% for adults aged 65 years and older in this population group. Previous estimates for Southern Africa have been set at around 2,1%.

The research by the Unit for Professional Training and Services in the Behavioural Sciences (UNIBS) at the UFS and Alzheimer’s South Africa is part of the International 10/66 Dementia Research Group’s (10/66 DRG) initiative to establish the prevalence of dementia worldwide.

Mr Rikus van der Poel, coordinator of the local study, and Prof. Malan Heyns, Principal Investigator, say worldwide 66% of people with dementia live in low and middle income countries. It is expected that it will rise to more than 70% by 2040, and the socio-economic impact of dementia will increase accordingly within this period. 21 September marks World Alzheimer’s Day, and this year the focus is on the global economic impact of dementia. Currently, the world wide cost of dementia exceeds 1% of the total global GDP. If the global cost associated with dementia care was a company, it would be larger than Exxon-Mobil or Wal-Mart.

The researchers also say that of great concern is the fact that South Africa’s public healthcare system is essentially geared toward addressing primary healthcare needs, such as HIV/Aids and tuberculosis. The adult prevalence rate of HIV was 18,1% in 2007. According to UNAIDS figures more than 5,7 million people in South Africa are living with HIV/Aids, with an estimated annual mortality of 300 000. In many instances the deceased are young parents, with the result that the burden of childcare falls back on the elderly, and in many cases elderly grandparents suffering from dementia are left without children to take care of them. “These are but a few reasons that highlight the need for advocacy and awareness regarding dementia and care giving in a growing and increasingly urbanized population,” they say.

Low and middle income countries often lack epidemiological data to provide representative estimates of the regional prevalence of dementia. In general, epidemiological studies are challenging and expensive, especially in multi-cultural environments where the application of research protocols relies heavily on accurate language translations and successfully negotiated community access. Despite these challenges, the local researchers are keen to support advocacy and have joined the international effort to establish the prevalence of dementia through the 10/66 DRG.

The 10/66 DRG is a collective of researchers carrying out population-based research into dementia, non-communicable diseases and ageing in low and middle income countries. 10/66 refers to the two-thirds (66%) of people with dementia living in low and middle income countries, and the 10% or less of population-based research that has been carried out in those regions.

Since its inception in 1998, the 10/66 DRG has conducted population based surveys in 14 catchment areas in ten low and middle income countries, with a specific focus on the prevalence and impact of dementia. South Africa is one of seven LAMICs (low and medium income countries) where new studies have been conducted recently, the others being Puerto Rico, Peru, Mexico, Argentina, China and India.

Mr Van der Poel says participating researchers endeavour to conduct cross-sectional, comprehensive, one-phase surveys of all residents aged 65 and older within a geographically defined area. All centres share the same core minimum dataset with cross-culturally validated assessments (dementia diagnosis and subtypes, mental disorders, physical health, anthropometry, demographics, extensive non-communicable risk factor questionnaires, disability/functioning, health service utilization and caregiver strain).

The local pilot study, funded by Alzheimer’s South Africa, was rolled out through an existing community partnership, the Mangaung University of the Free State Community Partnership Programme (MUCPP).

According to Mr Van der Poel and Prof. Heyns, valuable insights have been gained into the myriad factors at play in establishing an epidemiological research project. The local community has responded positively and the pilot phase in and of itself has managed to promote awareness of the condition. The study has also managed to identify traditional and culture-specific views of dementia and dementia care. In addition, existing community-based networks are being strengthened, since part of the protocol will include the training and development of family caregivers within the local community in Mangaung.

“Like most developing economies, the South African population will experience continued urbanization during the next two decades, along with increased life expectancy. Community-based and residential care facilities for dementia are few and far between and government spending will in all probability continue to address the high demands associated with primary healthcare needs. These are only some of the reasons why epidemiological and related research is an important tool for assisting lobbyists, advocates and policymakers in promoting better care for those affected by dementia.”

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt@ufs.ac.za  
21 September 2010

 

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