South African Clinical Trials: Turning Diversity into Opportunity
Eclectic demographics, rapid patient recruitment, and a burgeoning population with a gradient of disease profiles—these seem to be the fundamentals truly driving growth in South Africa’s clinical trial industry. However, without the presence of proper mechanisms to arbitrate between regulators and researchers, the sustained growth of this industry may very well be at risk.
Other significant advantages are being in western Europe’s time zone, the use of English as the language of clinical trial conduct and data recording…and year-round recruitment in global trials due to the inverse seasonality of the southern hemisphere.
In 2013, South Africa’s clinical trial sector was valued at roughly USD 27 million with over 1,600 trials registered according to ClinicalTrials.gov. Needless to say, South Africa acts as a strategic hub for more than just its sound investment climate and established business infrastructure. The nation’s eclectic spread of demographics and disease burdens has attracted many of the most prominent names in the pharmaceutical and biotechnology industry for clinical research—only fuelling the growing presence of not only multinational contract research organizations (CROs), but also local.
“South Africa’s combined characteristics of first and third world medicine have long been recognized as attractive to clinical research,” asserts Victor Strugo, managing director of Triclinium Clinical Development. “Two decades of social upliftment have additionally established a third tier of affordable semi-private medicine that brings treatment-naïve populations closer to state-of-art diagnostic methods and research-equipped facilities.”
“Other significant advantages are being in western Europe’s time zone, the use of English as the language of clinical trial conduct and data recording…and year-round recruitment in global trials due to the inverse seasonality of the southern hemisphere. We also have a long-established good clinical practice (GCP) culture: the first global registration trials were done here in the 1970s, since when the South African investigative community has grown, both in the high-tech private sector and the larger academic-affiliated public sector, accelerated by the Medicine Control Council’s (MCC) conscious push for trial sponsors to build research capacity,” Stugo adds.
From the perspective of Sizakele Mphele, founder and managing director of LT clinical research, one of the first wholly black-owned South African CROs, “South Africa has a very conducive environment for clinical research. The diversity in our patient population makes it a clinical research friendly country.” That being said, however, Mphele says, “there have been some criticisms of our regulatory framework, with a suggestion that it is bringing down the clinical trials industry.”
Any company currently looking to conduct clinical trials in South Africa must first secure approval from the MCC, while also registering the trial with the official South African National Trial Register, which was established in 2005. Compared to the apartheid era, the regulatory regime in South Africa has significantly evolved to protect the interests of health professionals, patients, and ethicists alike.
But some might argue that regulatory governance has become too stringent and over bearing. “Unfortunately, our forward momentum is very much limited by our regulators, the Medicine Control Council (MCC), especially when our activities do not directly fall in line with the nation’s therapeutic priorities,” claims Catherine Lund, co-owner of OnQ Research. “Though, at a recent stakeholder workshop, the MCC expressed resolute intentions on reforming this dynamic, which has largely remained unchanged over the years.”