Enhancing the methodology of clinical trials in older people: A scoping review with global perspective

As people age, they are more likely to develop chronic diseases, experience physical and mental impairments, and face social issues. This complexity makes traditional research protocols challenging, leading to the exclusion of older individuals in clinical trials (CTs) and limiting the applicability of evidence-based medicine, especially in low- and middle-income countries (LMICs).

A scoping review of the literature (based on PubMed, Embase, and Scopus) was conducted to identify recommendations to improve the methodology of CTs involving older persons. The findings were then shared with a panel of researchers with expertise in older adult research in LMICs, who assessed and refined the recommendations for implementation in low-resource settings.

After screening more than 4,700 articles, 80 were retained as relevant, providing 1,119 inputs on the design and conduct of CTs in older persons. These inputs were homogenised into 120 recommendations and organised into 13 clusters representing different phases and aspects of a CT. Key recommendations, enriched from experts’ input, indicate the importance of addressing various barriers that hinder older persons' participation in CTs in LMICs, such as poor funding, inadequate age-friendly facilities, ageism, transportation issues, and the need for standardised terminology and culturally sensitive assessment tools.

CTs involving older individuals face unique challenges. Effective methodologies and innovative approaches are essential for generating scientific evidence that informs clinical practice and promotes healthy ageing. The present work highlights the need for practical, inclusive strategies to navigate the complexities of conducting CTs in older adults.