Clinical trials framework proposed to bring cancer treatments to sub-Saharan Africa
July 20, 2017
Physicians who seek to bring to sub-Saharan Africa cancer treatments available in other parts of the world often are hindered by a lack of clinical trial data showing how these treatments might help or harm patients in the region.
That is the finding of a study by Satish Gopal, MD, MPH, adjunct assistant professor of epidemiology at the UNC Gillings School of Global Public Health and published July 10 in the journal PLOS Medicine.
Gopal, a member of the UNC Lineberger Comprehensive Cancer Center, is cancer program director for UNC Project-Malawi, a care, research and training collaboration between UNC-Chapel Hill and the Malawi Ministry of Health in Malawi, a country in southern Africa that is home to more than 18 million people.
In the journal article, Gopal outlines a framework to design studies and bring cancer therapies to sub-Saharan Africa in the absence of clinical trial data specific to the region’s population and health care infrastructure.
UNC researchers are working to open clinical trials in Malawi to test treatments already available in the United States, as well as to study possible novel agents. Cooperative clinical trial groups sponsored by the National Cancer Institute have begun working in the region as well, with UNC Project-Malawi being one of the regional centers recruited to participate in their efforts.
“The concept of evidence-based medicine is to take studies that have been done in populations similar to one’s own, and use the results of those studies to inform practice and health-care guidelines,” Gopal said. “The problem in sub-Saharan Africa, where more than one billion people live, is that we have little evidence from this part of the world specifically.”
Often, one hears two diametrically opposed ways of dealing with this problem.
One approach, Gopal noted, is to use data from clinical trials done elsewhere to develop identical treatment strategies for sub-Saharan Africa. However, he said, that approach does not account for issues specific to the population in the region, such as differences in tumor biology, the burden of infectious diseases, and differences in health-care infrastructure.
For example, he said, there are no radiation oncology services in Malawi. Major deficiencies in supportive care for patients also limit the intensity of chemotherapy that can be safely administered.
The alternate strategy is to repeat all trials in sub-Saharan Africa to guide care in the local context, but Gopal said this is simply not feasible.
“There has to be a sensible middle ground,” he said.
Gopal argued that trials may be required for some treatments, while for others, new data may not be required if the drugs have been shown to be particularly well-tolerated and efficacious. For example, he said, the favorable therapeutic ratio for the drug imatinib, for chronic myelogenous leukemia, led to the launch of the Novartis Glivec International Patient Assistance Program, one of the most “far-reaching global oncology pharmaceutical access programs ever attempted,” without first requiring new clinical data in low-resource settings.
“How can trials be designed in a way that both produces new knowledge relevant for the region, while also resulting in the highest likelihood that patients in Malawi get an effective treatment for their cancer?” Gopal asks. “This question is central to contemporary cancer clinical trial design, and is being asked even here in the United States.”
Gopal called for nuanced discussions about what types of evidence are required and at what point evidence is sufficient to advocate for implementation in sub-Saharan Africa.
“The global cancer community needs to tackle these issues, with specificity for this part of the world,” he said.
A version of this article first appeared on the UNC Lineberger Comprehensive Cancer Center website.