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 drugDr 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.