Clinical Trials Arena: What are some of the challenges you face starting up clinical trials in South Africa?
Industry Expert: From a regulatory standpoint, the main challenge that many talk about is the variability and duration of regulatory agency (Medicines Control Agency, MCC) approval timelines. I don’t have official industry-wide timelines for the MCC approvals but our experience is that this ranges from four to six months which is not that bad when looking across global National Health Authority timelines.
CTA: How do you work with groups of patients that might be naïve to clinical trials?
IE: We work in tuberculosis (TB) vaccine research, and we find that it’s important to work in communities with high TB incidence. These are often also communities where education levels are lower, making them a vulnerable population. This means we need to work through our clinical trial sites to ensure communities are appropriately educated about clinical trials, TB and vaccines before we can conduct trials in that community so that potential participants are making informed decisions and so that the community is supportive of the trial work. This takes investment of time and financial resources prior to conducting and throughout a clinical trial.
Despite these challenges, South Africa has a remarkably sophisticated infrastructure for clinical trials and trials conducted here are on par with those conducted in the U.S. and Europe and are run to the same international standards.
CTA: What’s apparent in South Africa is that approval timelines can be an arduous, long drawn out process. How do you mitigate that to ensure your trial goes according to plan?
IE: One of the benefits of conducting trials in South Africa is that ethics and regulatory (Medicines Control Council, MCC) approvals can be obtained in parallel, with the caveat being that final approval is only in place once each has received each other’s respective approval letter. Additionally, those who work regularly in South Africa know what the MCC looks for in trial applications. We try to address all requirements by including all sites and investigators in the first application. We look to ensure our applications are of a very high standard to prevent unnecessary delays and reduce the burden on the MCC. For initial applications submitted in this way trial sponsors can plan their trial timelines with a four – six month approval time in mind. At our company, we also try to prepare as much as possible during this approval pending time so that once the final approval is in place we are ready to start our trials.
CTA: How would you describe the patient pool in South Africa?
IE: South Africa has a very diverse population (socio-economic, rural-urban and racial diversity), which makes it an ideal location for research as both diseases of affluence and poverty are prevalent. What’s more, interventions can be studied across a variety of genetic backgrounds.
CTA: In your experience, have you ever found it to be the case that the patient population is eager and keen to participate in clinical trials?
IE: As we primarily focus on healthy populations for our trials, eagerness to participate is very dependent on three factors:
- The level of community education on the need for new vaccines
- Their understanding of the link between clinical trials
- Their awareness of the potential for new TB vaccines in the future
In the communities we work in, we’ve found that the clinical trial sites have done a very good job of this on the whole and finding willing volunteers has not been difficult. This may also be due to the nature of the communities where we work as the prevalence of TB in these communities is very high. Therefore, most people have family or friends who have been affected by TB and, as a response, they are eager to be part of trials to help develop a new vaccine.