South Africa's "distant" proximity to the US, along with an accompanying ignorance and lack of perception about what the country has to offer in terms of clinical research are partly to blame for this, Catherine Lund, vice chapter head of the South African arm of the Associate of Clinical Research Professionals (ACRP) and founder of South Africa-based CRO OnQ Consulting, told Outsourcing-Pharma.com. The country's "cumbersome" regulatory environment has also been a deterrent to some people considering including South Africa in a global study. Currently it takes 12-14 weeks from trial submission to approval, compared to around a month for most western countries, said Lund. "On the surface, this can turn potential sponsors off," she said. However, in terms of its competition with other emerging markets and offshore locations, South Africa does not seem to be faring so badly… In Latin American countries, regulatory timelines are considerably longer - it often takes 9 to 12 months to have a site up and running - while the Japanese clinical trial environment has typically been less than welcoming, burdened by red tape and language barriers, although the government is in the process of pushing through a series of proposed reforms to change this. On the other hand, Russia is planning to implement new, stricter legislations that will more closely regulate the country's clinical trials industry, including making it a requirement that in order to run a clinical trial, a site will now be required to obtain permission for each individual trial it plans to conduct, as opposed to the current system where a site is just required to undergo an accreditation procedure that would cover it for all future studies at its medical facilities. Lund identified Eastern Europe and India as the main regions that South Africa is competing with in terms of attracting clinical business, but said that "Eastern Europe is getting more and more expensive, so South Africa has a cost advantage there." However, India, which has historically also had a very cumbersome regulatory process, has really lifted its game over the past year and now poses more of a competitive threat, with a low cost base and now a short regulatory turnaround time. There have been lots of positive regulatory developments in the country since January, one of which slashed the turnaround time for a company to obtain permission from the regulator to run a clinical trial from between 10 and 16 weeks, to between two and four weeks for trials in category A, and between six and eight weeks for those in category B.
Category A trials are those that already have the protocol approved in one of a number of countries on an approved list. The remainder are placed in category B. Lund did point out, however, that some questions have been raised over various issues of quality in India, including by publications such as Centerwatch, and this is where she believes South Africa may have an advantage. South Africa, has a very stringent regulatory system aimed at protecting its citizens and this year has been strengthening existing laws to improve the quality and transparency of trials human research, including making it compulsory to publish both positive and negative results of trials. The country first established a national clinical trials register in 2005, where once a trial is approved by the ethics committee, the details are automatically registered. It was one of the first countries in the world to have such a system. The country's National Health Research Ethics Council is also in the process of setting up an accreditation process to standardise the processes of the over 30 ethics committees in operation. "Therefore, if we [South Africa] can streamline our regulatory process then we will reduce a major obstacle," Lund said. "Currently the South African regulators are under-resourced and communication is a problem." However, a task team comprised of representatives from the industry, government and trade associations are all working together to make positive changes, and it is hoped that new reforms will be implemented next year, she said.
In the meantime, Lund believes that South Africa's advantages lie in its patient population of nearly 50m, many of which are treatment naïve and have a wide diversity in genetic backgrounds. "Because of this we often recruit for trials quite quickly compared to other parts of the world." The country is also a popular choice for sponsors who need a 'rescue site,' for rapid recruitment if another one elsewhere in the world has failed to recruit enough patients in time, she said. Furthermore, the country is also growing as a location to conduct seasonal studies, as it is in a different hemisphere to the US and Europe.
In addition, Lund indicated that South Africa is also a perfect launching pad for the increasing numbers of sponsors who are looking to gain exposure to African patients in order to broaden their overall clinical trial patient base to give the study a more global picture, as well as to run trials for new drugs to treat diseases that are highly prevalent in this region, such as HIV.