We’ve previously touched on the potential benefits of using mobile technology in conducting clinical trials in developing countries. As the Longboat global footprint expands it’s becoming quite obvious that parts of the globe are poorly represented when it comes to industry-sponsored trials.
Here, we’ll talk about other initiatives that are enabling more clinical trials to be carried out in the world’s second-largest continent: Africa.
Current picture: the challenges
Clinical trial numbers across this continent are highly uneven. For example, in one analysis, the range was immense: from 1 (Mauritania and Djibouti) to >2000 (South Africa and Egypt) in the period 1991 to the end of May 2018.
Reasons for this stark variance are well known and include huge disparities in funding, regulatory standards, research and development capacities, availability of skilled personnel, and the infrastructure required to host and manage clinical trials. For example, South Africa invests heavily in health and has a relatively well-developed healthcare system, which is reflected in the number of clinical trials hosted there.
Indeed, the economic performance (and stability) of a country directly affects the provision of healthcare services—if there is little money, how can investments in equipment, medicines, staff, clinics, etc. happen? One report noted that there is a healthcare financing gap of $66 billion per annum in Africa, which in turn limits public investment in health.
Regarding staffing, the report also highlighted the severe shortage of skilled health professionals throughout the continent. Of the 47 countries for which data were available, 13 have fewer than 5 health professionals per 10,000 population (compared with global numbers of 23 health professionals per 10,000 population).
Running a clinical trial is a highly complex process; so, to conduct a trial in a low-resource setting requires substantial investment to ensure local and international standards, such as the Good Clinical and Laboratory Practice, are met. For example, building of laboratories, purchase of specialized medical equipment, and the development of “cold chain” systems (a process to maintain a product within a specified low-temperature range from harvest/production to use) are often needed. At the other end, the lack of ethics committees and clear regulatory guidelines, language barriers, and difficulties in data collection are also cited challenges.
It’s not surprising then, that there is such a range in clinical trial activity in Africa; however, this picture is changing.
Above is an interactive heatmap to demonstrate the clinical trial registration rates on the African continent. Click on various sections of the map to get a feel for the clinical research activity in this region. More information on the heatmap, and the data within:
- The data is from ClinicalTrials.gov, which is not a true global repository of registered clinical trials but is the most comprehensive clinical trial registry in the world.
- Registration data for clinical trials can take up to 12 months to appear online, so we have included the most recent 3 years of complete data we have at time of writing (2019).
- Click the double-sided arrow icon, in the bottom right of the module, to enter full-screen mode
- Click on a year to select or deselect the data from that period
- Click on a country to select or deselect the data from that geographical area
- Mouse-over a country to see more information
In May 2014, Ethiopia celebrated International Clinical Trial Day for the first time, with the motto “Clinical Trials for Excellence in Patient Care.” Over the years, there has been a growing buzz in Africa regarding the immense opportunities of leveraging clinical trials to inform local, and international, healthcare decision-making.
Africa is currently facing an interesting “double burden of disease” challenge – high communicable diseases and increasing noncommunicable diseases – which increases national healthcare costs and has potential implications on the types of clinical trials that will be conducted in the future. Although infectious diseases such as HIV, malaria, and tuberculosis account for >50% of the disease burden in Africa, rapid demographic changes are leading to an increase in noncommunicable diseases such as heart disease, obesity, and diabetes.
Investment in healthcare by governments in Africa is increasing, but public–private partnerships will also play a large complementary role in bridging the funding gap. For example, investments made in setting up a clinical trial can benefit a local community by improving standards of care as a result of better disease surveillance and access to healthcare facilities.
Sharing expertise and knowledge, and building collaborations within and outside Africa are also fueling awareness and interest in clinical research and trials. To help sponsors navigate regulatory aspects of a trial, helpful guidelines are available, but the most important development in recent years includes the launch of the Pan-African Clinical Trials Registry (PACTR) in 2009 and the imminent establishment of the African Medicine Agency (AMA). Both these initiatives aim to harmonize processes across national boundaries, maximize the use of limited resources, and deepen capacity building.
Finally, harnessing digital and mobile technology to improve healthcare and empower patients is also a growing industry in Africa. Although on average only 41% of the population in sub-Saharan Africa used the Internet in 2018 (vs 89% in the United States), mobile phone ownership in Africa is on par with the United States: 75%–91% vs 95%, respectively.
Numerous researchers have reported their experience with running a clinical trial in Africa, and they provide valuable sources of information. For example, this article details the specific difficulties experienced in (and proposed solutions for) an investigator-initiated trial in Cameroon (a summary figure from the article is provided below).
Managing different expectations of stakeholders is also important. One of the suggestions that these authors made includes having clinical trials ensure that there is a clearly documented memorandum of understanding with local healthcare staff at the start of the study, to identify the level of trial support required, and to develop an exit strategy for handing over responsibilities and equipment to the facility or key stakeholders when the trial ends.
Regarding patient retention, one study highlighted the important role that mobile phones had in maintaining high levels (>92%) of patient engagement in a trial of an Ebola vaccine during an epidemic. However, if mobile phones are used as a means of enrollment, allocation, or data capture, then charging facilities, battery life, and the cost of mobile data should be taken into consideration.
Together with significant government investments in healthcare in the region, and the acknowledgment of the important role that the private healthcare sector has in driving this initiative to increase the number of clinical trials, we see Africa as a continent in which clinical trials will see substantial growth. Technology might even help accelerate the process, a sentiment that Joris van Dam (Strategic Projects Leader at Novartis) notes in this article:
“In many ways, Africa is a ‘greenfield’ site that allows us to introduce innovative approaches at the outset,” van Dam says. “That’s much harder to do where hospitals and clinics are wedded to their legacy systems. There’s an opportunity here for lower-income countries to use digital and mobile technologies to leapfrog inefficient data-collection processes used in the West, and so position themselves to conduct far more clinical research.”
Challenges and Solutions for Conducting Clinical Trials in Low-Resource Settings
Source: Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lang T. The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial. Trials. 2011; 12:145.