EQUITY IN CLINICAL TRIALS: ADDRESSING GENDER, AGE, AND SOCIOECONOMIC BIAS IN THERAPEUTIC RESEARCH

Abstract

Clinical trials underpin therapeutic innovation, yet persistent inequities in participant representation limit the universality and applicability of findings. Gender, age, and socioeconomic disparities compromise both scientific reliability and the ethical principle of justice. The study aimed to assess trends of inequality in clinical trials by gender, age, and socioeconomic factors and to make recommendations regarding incorporating inclusivity into trial design and conduct. A mixed-methods approach was used, combining quantitative analysis of 220 interventional trials registered between 2013 and 2023 with qualitative synthesis of policy guidelines. Data were accessed from key international trial registries and supplemented with peer-reviewed guidelines. Descriptive statistics and inferential statistics estimated demographic representation, whereas thematic analysis brought out systemic determinants of exclusion. Outcomes proved that only 67% of trials gave data on sex distribution, 55% on age stratification, and 32% on socioeconomic indicators. Female recruitment in cardiology was 39% versus a prevalence of 52%, showing a gap of −13%. Oncology trials excluded older adults most often, 40% using upper age restrictions, and just 19% included participants ≥70 years. Socioeconomic disparities were significant, with rural involvement at 10% and remuneration provision as low as 14% in impoverished environments. Government-sponsored trials were more inclusive than private trials. Significant disparities remain within clinical trials, limiting generalizability and perpetuating health inequities. Provision of transparent demographic reporting, inclusive eligibility, and socioeconomic support mechanisms is needed to promote both the scientific validity and public impact of therapeutic development.