AI/ML-based strategies for enhancing equity, diversity, and inclusion in randomized clinical trials

Abstract This paper introduces a conceptual framework designed to embed equity, diversity, and inclusion (EDI) across all stages of the clinical trial lifecycle. Randomized clinical trials (RCTs) remain the most reliable method for evaluating medical treatments, yet persistent gaps in representation undermine their validity and fairness. Women, older adults, racial and ethnic minorities, and socioeconomically disadvantaged groups are often underrepresented, raising concerns about whether trial results can be generalized to all patients. This lack of inclusivity not only limits scientific rigor but also risks reinforcing existing health disparities. Recent advances in artificial intelligence (AI) and machine learning (ML) provide new opportunities to address these challenges. These technologies can support more inclusive study designs, enable targeted recruitment of underrepresented populations, and monitor diversity in real time throughout the trial process. They can also be applied to analyze outcomes with fairness-aware methods, helping ensure that results are meaningful across diverse subgroups. In this work, we propose an AI/ML-based framework aimed at operationalizing equity, diversity, and inclusion in clinical research. The framework integrates predictive modeling, adaptive trial designs, and continuous bias detection with ethical and legal safeguards to ensure responsible deployment. By embedding fairness into every stage of the trial lifecycle, this approach offers a pathway toward more representative and trustworthy evidence in medical science. Our analysis reveals the persistent gaps across demographic groups in current RCTs, demonstrating the urgent requirement for systematic intervention. This study also contributes a comprehensive AI/ML framework that operationalizes equity through predictive modeling, adaptive designs, and continuous bias monitoring, providing a structured pathway for researchers to enhance both the scientific validity and ethical integrity of clinical trials.