Dr. Hoffman Discusses Sanaria’s Clinical Trials in Africa
On November 21, 2023 an article discussing best practices for conducting clinical trials in Africa was published. Sanaria’s CEO, Dr. Stephen Hoffman, was interviewed and talks about our experience. Original posting can be found here.
Best Practices For Conducting Clinical Trials In Africa
Source: Clinical Leader
By Life Science Connect Editorial Staff
The future of clinical trials is global, as more sponsors and companies work internationally to develop drugs that can be approved for multiple markets and reach millions of people. Global trials also attract companies looking to increase patient diversity and recruitment. However, even though over 18% of the world’s population lives on the African continent, only a small percentage of clinical trials worldwide are conducted there.1 Given the region’s rich ethnic diversity and developing healthcare infrastructures, the continent may become the next frontier of clinical research.
Clinical Leader’s editorial staff interviewed three industry leaders researching lifesaving therapeutics on the continent. Stephen L. Hoffman, MD, chief executive and scientific officer of Sanaria, Carol Nacy, Ph.D., co-founder and CEO of Sequella, Inc., and Robert Wallis, MD, chief science officer at The Aurum Institute, shared their best practices for conducting clinical trials in Africa.
Which Clinical Trial Phases Should Companies Perform In Africa?
Many infectious diseases, such as tuberculosis (TB) and malaria, disproportionately affect Africans compared to the rest of the world. Likewise, cancer rates are rising across the continent.2 Given the prevalence of many diseases and conditions and the lower costs associated with running clinical trials in this region,3 the opportunity for drug research in Africa is rich. Nonetheless, companies must strategically consider several factors when determining which phases of a clinical trial to conduct in African countries.
First, it’s important to remember that the continent is not a monolith. Healthcare infrastructures vary widely by country. For example, South Africa has top-notch healthcare and academic institutions, but some of its neighbors in the region would require companies to build research facilities from the ground up. However, developing countries are often amenable to working with companies to create the infrastructure needed to conduct trials, given their citizens’ needs. Both approaches can be cost-effective, and both can benefit local populations. However, companies may want to begin their studies in the U.S. or Europe before bringing them to an African nation.
“During the early development of a new TB drug at Pfizer, we were able to take advantage of Pfizer’s resources to conduct the Phase 1 studies in Connecticut before conducting Phase 2 studies in South Africa,” recounted Wallis. “This went very quickly. It also benefited from the company’s extensive experience in early phase trials. But we needed to bring the drug to patients, and South Africa was the best choice for Phase 2.”
Wallis also notes that there is growing interest in African countries, particularly South Africa, to create clinical research sites, increase regulatory support, and engage in more studies. Nacy also encourages companies to conduct Phase 1 research in the U.S. or Europe before beginning trials in Africa for ethical reasons. Building trust across cultural divides is difficult, but companies that have proven their drug is benign to humans before bringing trials to developing nations demonstrate their concern for the health and safety of local populations.
How Can Companies Ensure Patient Centricity?
Patient centricity is the cornerstone of an ethical clinical trial, but global studies present unique complications. To overcome them, companies must prioritize relationships and respect. For example, bridging cultural gaps begins with respecting local customs and traditions and providing all training and informational materials in local languages. Companies also succeed when they partner with governmental health officials and local investigators while creating the study rather than offering one-size-fits-all strategies.
“It sounds simple, but to launch a study in Africa, you must start with humility and be prepared to work hard,” Hoffman explained. “You have to respect the local people and not come in thinking that you know better than they do. Studying diseases where there is great need is a gift, and when you look at it that way, you do your due diligence to ensure everything is conducted ethically.”
After building local partnerships, companies can work with them to recruit patients for the trial, such as collaborating with HCPs to provide information at a clinic and obtain consent from patients for screening. Once screened, patients benefit from direct contact, such as a phone call, to answer questions and set up appointments. When appropriate, providing translators or interpreters to walk through the consent process also helps patients enroll. Also, given the high poverty rates in some countries undergoing clinical research, providing primary healthcare and other services encourages patients to participate.
“We employ several methods to build a relationship of trust with our patients,” Wallis stated. “First, we share the clinic’s telephone number and ensure that people are available after hours to answer questions or receive adverse effect reports. Second, we understand that TB rates are higher in patients who also suffer from malnutrition. We often arrange food supplements on an ongoing basis for patients enrolled in the studies. These methods provide holistic patient care and encourage more subjects to enroll via word of mouth.”
How Are Local Investigators Engaged?
Equipping local investigators is another crucial step, especially when launching studies in countries that lack experience with clinical research. Companies benefit from partnering with local universities and government institutions to teach emerging investigators the nuances of clinical research. This training represents a long-term strategy in which investigators prepared for one study are thus equipped both for subsequent studies and to teach others underneath them, organically creating a dedicated workforce for future research. Likewise, expanding university-level educational opportunities for researchers is vital to creating more studies in Africa. To this end, the European and Development Country Clinical Trial Partnership creates graduate study opportunities for interested researchers who can teach others and increase the talent pool in their communities.
“We recently learned that a team at the Kenya Medical Research Institute-Wellcome Trust Research Programme, used the results of our collaborative studies in which Kenyans were injected with Sanaria’s PfSPZ Challenge to cause malaria to facilitate 10 Kenyan scientists achieve their Ph.Ds.,” stated Hoffman. “Those 10 Ph.Ds. will teach many more students, and research in that region will grow.”
When establishing a new clinical trial infrastructure, companies must also prepare local HCPs for their role. HCPs are accustomed to finding creative solutions to patient problems, but clinical trials require strict protocol adherence. Equipping these HCPs to conduct studies begins with educating them on providing patient care while following the protocol. However, companies that are just starting to conduct research in Africa are advised to begin with a country that already has an excellent medical system, so they are not starting from scratch.
How Can Studies Meet International Standards?
Companies working in countries without strict regulatory standards are advised to use FDA, EMA, or ICH guidelines to ensure that their research meets international standards. The EMA, in particular, has been working with African authorities to improve the regulatory landscape for clinical trials in the region.4 Meanwhile, the African Medicines Agency (AMA), a pan-African regulatory organization, aims to harmonize medicine regulation across the continent.5 As clinical research expands in Africa, the AMA is expected to play a key role. Another pan-African agency, the African Organization for Research and Training in Cancer (AORTIC), is working to build up cancer research. AORTIC has advocated for increased clinical trial activity in Africa and has made recommendations to standardize their conduct. Meanwhile, national entities are making great strides in creating regulatory bodies that follow internationally recognized best practices, such as the South African Health Products Regulatory Authority.
“There’s a strong push by regulatory agencies to confer with each other and ensure that requirements are similar, if not the same,” reported Nacy. “We use ICH and FDA guidelines, and our protocols are driven that way because that’s where the drugs will be registered first. Next, we work with national agencies in the countries where we’re conducting research to get their comments on our protocols. They often have different questions than those posed by the FDA, so it takes time to work out the details. But in the end, we have a protocol that meets everyone’s standards.”
Finally, drug development involves many players, and most companies turn to CROs and CDMOs to fill in gaps. Research in Africa is no different. Fortunately, many internationally known vendors work in African countries, are culturally competent, and understand how to navigate differing regulatory requirements. As clinical trials in Africa expand, more vendors are expected to work in this space and provide crucial support services that will allow for a wide range of diseases and conditions to be studied.
An example of completing all elements delineated above occurred in Equatorial Guinea (EG) in the past decade. A team composed of individuals from the EG Ministry of Health and Social Welfare, Sanaria, the Ifakara Health Institute from Tanzania, three US energy companies, Medical Care Development International (MCDI), and Swiss Tropical Public Health collaborated to form the EG Malaria Vaccine Initiative (EGMVI). The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The EGMVI has completed three trials of Sanaria’s PfSPZ vaccines in EG, two PfSPZ vaccine trials in Tanzania, and a malaria incidence study in EG.
The clinical trial landscape in the African continent is growing rapidly, but there is ample opportunity for companies looking to enhance patient diversity while increasing ROI. By following the best practices identified by leading experts in the region, companies can conduct leading-edge research, improve patients’ lives, and leave a legacy of bringing lifesaving drugs to the populations that need it most.
