Africa: The Case for Including More Babies and Young Children in Medical Research
[spotlight] All medicines and treatments have to go through lengthy safety and efficacy testing, but this is particularly tricky - and often delayed - for one important age group. Spotlight explores the complexities of conducting clinical trials involving babies, and why those complexities are worth grappling with.
The inclusion of babies and young children in medical research is a topic of significant importance yet often overlooked. Despite the fact that all medicines and treatments require rigorous safety and efficacy testing, this aspect is particularly challenging for this age group. Babies and young children are at risk of developing illness and severe disease, yet they are seldom included in clinical trials, leaving doctors with limited scientific evidence to make informed decisions regarding their care.
According to a 2025 technical report by the World Health Organisation (WHO), only a tenth of clinical trials globally include babies, with an even smaller fraction conducted in lower- and middle-income countries. This disparity is attributed to constraints such as smaller markets for baby-specific medicines, commercial incentives, ethical and regulatory complexities, and the scarcity of safety and efficacy data for many medicines used in children.
The issue of under-researching infants is not new. A 2015 article in the British Journal of Clinical Pharmacology highlighted the scarcity of safety and efficacy data on many medicines used in children, often leading to the administration of ineffective medicines or those with unknown harmful side effects. These children are commonly referred to as therapeutic or pharmaceutical orphans.
Despite the clear need for more research in infants, the incentives for conducting such research are not always present. Pharmaceutical companies may be hesitant to invest in trials involving children due to decreased commercial interest, higher costs, and increased liability risks. Additionally, ethical questions surrounding consent and the balance of potential benefits and harms further complicate the matter.
Clinical pharmacologist Professor Marc Blockman of the University of Cape Town (UCT) acknowledges the anxieties surrounding clinical trials in young populations but emphasizes the importance of doing so when necessary. He stresses that as long as the clinical situation involves the age group and cannot be adequately tested in another group, utilizing a young population is appropriate.
Ann Strode, a Professor in the School of Law at the University of KwaZulu-Natal, underscores the necessity of protecting the rights of children in research, citing various frameworks and the South African National Health Act that outline the need for consent and consider the vulnerable status of children in health research priorities.
However, obtaining consent for infants is often challenging, as they cannot provide full medical research consent, with parental or guardian consent being the usual alternative.
The South African Health Products Regulatory Authority (SAHPRA) and the National Department of Health have published guidelines for conducting clinical trials involving children, emphasizing the importance of explaining risks, particularly for embryos, foetuses, and nursing infants, and considering the burden of disease and resource implications.
Blockman advocates for a staggered approach to conducting trials in children, starting with slightly older children to gather initial data before progressing to infants. This approach aims to balance the necessity of research with the need to minimize risks to vulnerable populations.
Written by urgent.news from AllAfrica Health's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
