ABSTRACT:
Integrating Sex as a Biological Variable (SABV) is critical for reliable and generalizable preclinical evidence. However, female models are frequently underrepresented, and outcomes are rarely analyzed by sex, limiting detection of sex-specific differences in disease mechanisms and treatment response1. This gap is especially consequential in Africa, where populations face a double burden of persistent infectious and climate-sensitive conditions2 alongside rising non-communicable diseases3, heightening reliance on biomedical interventions. Biological sex influences pharmacokinetics, immune responses, and disease susceptibility4; neglecting SABV propagates bias, undermining intervention effectiveness and health equity5. Despite international guidance, no systematic analysis quantifies the SABV gap in African preclinical research or examines policy drivers. A bibliometric analysis of preclinical studies published by African institutions between 2010-2024 will be conducted, using PubMed/MEDLINE, African Journals Online, African Index Medicus, and Scopus. Eligible studies include original animal, cellular, or tissue-based research with African institutional authorship. Variables extracted will include disease domain, model type, sex reporting, and use of sex-disaggregated analyses. In parallel, SABV-related policies from African and international funders and high-impact journals will be mapped to assess alignment with research practice. Our analysis is expected to demonstrate persistent and significant gap in SABV reporting across a decade of African preclinical research, with minimal improvement over time. We predict a clear disconnect: while major international funders have thorough SABV policies, their translation into published research from African institutions will appear weak. The synthesis will crystallize this problem by illustrating how the omission of female models limits the relevance of findings for half the African population. This study will provide the first quantified, Africa-specific evidence on SABV integration in preclinical research and identify a policy/practice gap with implications for health equity. Findings are designed to catalyze advocacy for enforced funding and publication mandates, ensuring future research yields equitable and effective interventions for Africa's populations