As clinical trials become increasingly globalised, more and more companies from the US and Europe are widening their scope to conduct studies in foreign countries. There's a host of opportunities in emerging markets offering sponsors cheaper, more cost-effective ways to conduct their trials abroad. For the small companies operating on a tight budget, running trials abroad is perhaps their most realistic option. In South Africa, for instance, a diverse population presents itself as a prime location for running trials for companies of all sizes.
With both diseases of affluence and poverty prevalent throughout the country, interventions can be studied across a variety of genetic backgrounds. However, as is the case for many countries around the globe, conducting clinical research in a developing market does present a multitude of challenges.
"Here we deal with long approval timelines which, depending on the trial, can take roughly six to seven months to start up," said one clinical operations manager.
Dealing with lengthy approval processes is not a problem entirely unique to South Africa. In developing markets across the world, sponsors can encounter delays in study up for a multitude of reasons. In this instance, it partly boils down to resource issues as the South African regulatory body, the Medicines Control Council (MCC), has been suffering from a shortage of reviewers for a number of years.
However, recently, there has been a huge restructuring within the regulatory body, in an effort that seeks to shorten approval timelines. While the MCC is in the midst of changing the review process, the promised changes won't come into effect until early 2017.
To mitigate the shortage of reviewers, it is important sponsors put forward high quality submissions to the health authority to avoid multiple rounds of queries.
"In the time it takes to get approval, sponsors must use that time to ensure all the other components are put in place," the clin ops expert said. "Finalise your contracts, finalise your ethics approvals, do everything you can so that by the time you receive the approval document, you're ready to start the trial."
With a revamped health authority promising greater efficiency, clinical research in South Africa could improve significantly, certainly from an operational standpoint. But while some feel approval timelines are long, others argue they are manageable.
"We typically have a turnaround of four to six months to get an approval, which is something you can deal with," said another clinical professional.
For multinational studies, in particular, one of the more pressing issues for him is the growing disparity between the various levels of healthcare that's available in South Africa. When it comes to conducting a clinical trial of a novel therapy in a population that is only exposed to public health, the patients are mostly receiving a level of treatment, which the expert feels is arguably two times superior to the level of care they're currently receiving.
"The challenge here comes once the patient gets off that trial," he said. "What are the ethics around being placed on an inferior product - it would be classified as an inferior medicine - and not having access to something that's novel and new?"
That is arguably the biggest issue the industry in South Africa grapples with. For the most part, the problem stems from the country's socio-economic standing and the various levels of healthcare that's available. So how do you face that ethical dilemma head on? That ultimately depends on the kind of research you're conducting.
"If you're able to conduct this research in the private sector that would be preferable as there are fewer disparities and the ethical grey area is not as large," the clinical professional said.
However, he recognises that sometimes you have to go into the public sector because the patient population is difficult to find (in the private sector) depending on the trial. In order to mitigate circumstances, the South Africa DoH developed GCP guidelines on the conduct of clinical trials with human participants.
The guidelines - aligned with WMA (World Medical Association) regulations on post-trial access - say, in advance of a clinical trial, sponsors, researchers, and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.1
Therefore, sponsors are obligated to develop a plan that complies with this rule and it's something the MCC looks for in CTAs.
Despite the challenges that face the country, researchers in the main feel South Africa has a remarkably sophisticated infrastructure for clinical trials, noting that studies are conducted to the same international standards as in the US and Europe.
- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects - http://bit.ly/1dWyRro