Around the Globe: Africa
Drug Development and Clinical Research in Africa
Part 3: Drug Development from Africa to the World
Lisa Ursella Collins
Innomas Clinical Research
Leslie Sam
Leslie Sam and Associates
Jayesh Pandit
Patient Safety Advocate, Kenya
Helen Ndagije
Uganda National Drug Authority
Wangui Mathenge
International Society of Pharmacovigilance Africa Chapter

he life sciences industry must engage with the many key opinion leaders and subject matter experts across the African continent who offer deep technical and scientific knowledge about their patient populations, standards of care, health systems, challenges, strengths, and cultural particularities and priorities. The inclusion of more African countries in global clinical trials brings both concerns and hopes for researchers across the continent.

“My main concern in my people’s involvement in global clinical trial research is that the African voice (patients, participants, experts, and in some instances, the regulators) will not be silenced or minimized when they express themselves in their own accents, languages, and/or dialects during their engagements in a global trial,” explains Wangui Mathenge of the International Society of Pharmacovigilance Africa Chapter. “Whereas my hopes for Africa’s involvement in global clinical trials are heightened further with the inception plans of an African Medicines Agency (AMA) that is to uncomplicate and harmonize medicines regulation all across Africa. This will not only attract more sponsors, investors, and global clinical trials investigators in the region, but participation of more Africans in global clinical trials and research will be encouraged in an effort to boost biodiversity and inclusion in their studies.”

“Drug development in Uganda is on a trajectory that cannot be retracted,” Helen Ndagije of the Uganda National Drug Authority says. “Vast opportunities exist due to the increasing capacity to manufacture a variety of products from herbal medicines, medical devices like syringes, gloves, medical masks to sophisticated medical products like vaccines. The government of Uganda as well as many African countries have tremendously increased support to scientists for biotechnology development. During the peak of the COVID-19 pandemic, more Africans used herbal medicines for managing disease conditions. Uganda is endowed with a number of indigenous plant species that have traditionally been known to provide therapeutic properties. The opportunities for developing this potential further and for marketing such medicines is almost limitless.

“Diversity extends from the flora and fauna to the variety of tribes and lifestyles for which clinical trials can be conducted. These lifestyles impact on the use and indications for which drugs can be tested and eventually applied. The issue here is that of oral tradition. Culture is passed on from generations by word of mouth and writing is not an African thing! Yet science relies heavily on documentation. The first thing for industry would be to study culture and incorporate it into research methodology for development of new drugs.”

Ndagije’s concerns include the need for cGMP, for document review to ensure the safety, quality, and efficacy of investigational medicinal products and other clinical trial materials, and the urgent need for post-trial access: drugs that were studied in trials conducted in Africa but were not registered in Africa must be made more available to African populations long term after these studies are completed.

Companies have been founded in the US to help biopharmaceutical companies and contract research organizations increase minority and ethnic participation in research and trials and understand the importance of “developing relationships with communities of color within the US, helping them to learn about issues that impact their health” by educating and engaging them before getting to the clinical trial stage. These innovative and disruptive efforts and activities may well be needed to address similar challenges in Africa.

As the life sciences industry in the US acknowledges that data used to approve drugs for all populations is based on clinical trial participants that are 79.7% white and ~10% black (with only 43% of trials reporting race/ethnicity data), we will see a shift in traditional trial methods toward innovations that have the potential to advance truly global research.

Lack of diversity in clinical trials translates to harm and discriminatory practices in the medical field that result in racial biases. “Lack of diversity” has not always meant “lack of data” but rather the acceptance of inferences about nonwhite patient populations based on assumptions rooted in colonial, imperialistic ideology. Cases of medical bias across the medical field are not uncommon: Medical text books that only represent white-skinned patient cases result in under-recognition of dermatological conditions such as eczema, psoriasis, acne vulgaris, fungal skin infections, melanoma, etc.; inaccurate pulse oximeter readings in people with darker skin contributed to the disproportionate impact of COVID-19 on communities of color; the obstetric racism underlying the Vaginal Birth After Caesarean (VBAC) calculator; and the myth that black people have thicker skin or less sensitive nerve endings than white people.

If pharmaceutical companies want to contemplate ways to broaden their global footprint to include regions in Africa, they should not miss that Africa is a hotbed for innovation in many industries such as mobile banking solutions, telecommunications, technology, and agriculture. Taking the reins to ensure that research is designed for and by the populations across the 54 countries, with activities focused on the clinical and genetic data representative of the massively diverse African population, we have seen the emergence of research entities and biotech companies with African leadership. Such innovation is needed to also mitigate the risks of interventions not meeting global standards.

ISP’s Mathenge expresses this hope: “That the policymakers in Kenya and the rest of Africa will consider drug development and innovation an integral solution in enhancing universal health coverage. This is not only a win for the patients, but a win for the local research communities and experts, a win for the local and global drug makers, as well as a huge win for the African economy.”

In addition to supporting the advancement of science and healthcare across countries in Africa, increased clinical research will support the advancement of economies. A study site and trial in a rural area in a country in southern Africa created direct employment for over 450 local people over a two-year period. Local catering services, lodges, and other vendors benefited from the accommodation of national and international visitors to support the study.

Africa is Ready

There has been and always will be research coming out of Africa. African researchers have always tried and will continue to strive to resolve issues facing their populations, and to work to benefit not only Africans and those of African descent, but potentially all the populations of the world. However, it must also be acknowledged that unethical behavior in the global research community has (at times) negated the tireless efforts of researchers across the African continent.

In reference to papers with data from Africa which fail to acknowledge African collaborators, Sabine Kleinert, senior executive director of The Lancet, stated at the 2022 7th World Conference on Research Integrity: “We are now rejecting such papers because when you bring us such a paper you probably had a local researcher collecting data for you or you ‘helicoptered’ to Africa, but you chose not to recognize them, which is not acceptable.”

In the words of Shalom Lloyd, founder of Emerging Markets Quality Trials (eMQT): “Africa is ready!” Excluding the continent of Africa from the global research footprint is no longer acceptable. To ensure equitable healthcare for all, the inclusion of one or more Africa countries beyond South Africa or Egypt is necessary if the intervention will be intended for use across the African population.

The authors thank Ian Mugisa, Joyce Batera, Marvin Buleera, Keneth Mugisa, Diana Nakitto, and Sharon Kiggundu from the Uganda National Drug Authority for their contributions to this article.