Prof Mansoor Saleh: Why we should promote clinical trials in Sub-Saharan Africa

At the Aga Khan University Hospital in Nairobi and Medical College, East Africa, we have demonstrated that it is possible to conduct clinical trials with the same standards of quality and compliance as leading institutions in the West. 

Historically, global clinical research has been disproportionately concentrated in well-resourced countries. The vast majority of new treatments, including those for cancer, heart disease, and diabetes, have been developed and tested in Western populations. Fewer than two per cent of clinical trial participants are of African ancestry. This stark disparity raises critical questions about the efficacy, safety, and dosing of these life-saving therapies for African patients, whose genomic profiles differ significantly from those of their Western counterparts.

Beyond inclusion, this is a matter of equity and representation. Treatments made available in resource-constrained countries may not adequately meet the unique needs of the populations they serve. Yet with its youthful population, improving healthcare infrastructure, and expanding research capacity, Sub-Saharan Africa is well positioned to become a leader in global clinical research.

Inclusivity in clinical trials is not just a moral imperative, but a scientific necessity. Genetic variation, cultural beliefs, and socioeconomic factors can all influence how populations respond to therapies. Without representative data, treatment outcomes can be unpredictable.

While Sub-Saharan Africa bears a disproportionate burden of infectious diseases such as HIV/Aids, tuberculosis, and malaria, the region is also witnessing a surge in non-communicable diseases, notably cancer, diabetes, and cardiovascular disease. Yet only a tiny fraction of global clinical trials are conducted in Africa.

This imbalance forces African populations to depend on treatment guidelines derived from non-representative populations. For example, the blood thinner Warfarin is metabolized differently in African patients compared to Caucasians or Asians, resulting in unpredictable effects. In addition, the Beta-blockers, a common class of hypertension drugs, are often less effective in African patients at standard doses.

Africa is projected to experience the largest proportional population growth in the coming decades. As life expectancy increases, Africans will become significant consumers of therapies for chronic and age-related diseases. Including African populations in drug development is both a clinical and an economic necessity.

But inclusion is not limited to recruiting African patients, it also means empowering African scientists, clinicians, and patient advocates to co-lead clinical research initiatives. These include involving local experts in protocol design and ethical review, addressing cultural norms and rural healthcare access, and streamlining regulatory frameworks to support timely, ethical, and efficient trials.

Moreover, pharmaceutical companies must commit to ensuring equitable post-trial access to new therapies. Governments, in turn, must invest in universal health coverage and research infrastructure.

All standard treatments in use today were once investigation agents studied in clinical trials. Countless volunteers contributed to the development of the therapies we now rely on. Today’s patients, including those in Africa, deserve the opportunity to participate in and benefit from such research; ethically, voluntarily, and with the right to withdraw at any time.

Successful integration of Africa into the global research landscape requires pharmaceutical partners willing to invest in the continent, regulatory authorities prepared to conduct efficient, yet thorough reviews and local institutions dedicated to building strong, compliant clinical trial units.

At Aga Khan University Hospital in Nairobi and Medical College, East Africa, we have demonstrated that it is possible to conduct clinical trials with the same standards of quality and compliance as leading institutions in the West. Our Kenyan-trained research team matches the caliber of any I have worked with in the United States.

By fully embracing clinical research, we offer our patients access to novel therapies, enable African representation in international trials, and ensure that global innovations are relevant, effective, and safe for African populations. Now is the time for Sub-Saharan Africa to rise as an equal partner in the global pursuit of better health through research.

Prof Mansoor Saleh, chairs the department of haematology-oncology and is the founding director of the cancer centre at the Aga Khan University Medical College, East Africa and Aga Khan University Hospital, Nairobi.