Study by Luigina Guasti Published in The Lancet Calls for More Inclusive Clinical Trials for Older Adults

A major scientific contribution from the University of Insubria has been published in The Lancet, the world's leading medical journal, ranked first among 336 journals in the Medicine, General & Internal category and with an impact factor exceeding 109.

Among the authors of the scientific paper "Advancing the relevance of clinical trials for older patients" is Professor Luigina Guasti, Director of the Department of Medicine and Surgery at the University of Insubria, Chair of the Council for Cardiology Practice and Chair of the Geriatric Cardiology Task Force of the European Society of Cardiology.

The article – available at https://authors.elsevier.com/c/1nP-8V-4XWUtQ – addresses one of the most pressing challenges in contemporary medicine: ensuring that clinical trials are truly representative of older adults, the fastest-growing segment of the population and the group most likely to require medical care. Ageing is frequently accompanied by frailty, multimorbidity and cognitive impairment, making it difficult to apply evidence derived from younger, highly selected populations to older patients.

The paper examines the main barriers limiting the participation of older adults in clinical trials and reviews the most effective strategies already adopted internationally to overcome them. The priorities identified include recruiting an adequate number of older participants, adopting less restrictive inclusion criteria, tailoring therapeutic interventions to older patients, and selecting outcomes that are truly meaningful for this population, such as preserving functional independence, cognitive abilities and quality of life, alongside traditional measures of treatment efficacy.

The study also highlights the need to simplify recruitment procedures, provide greater support for patients and caregivers, and include individuals who have often been excluded from clinical research, such as those living with frailty or cognitive impairment. In addition, it presents examples of clinical trials that have successfully implemented these approaches, demonstrating that it is possible to generate scientific evidence that better reflects real-world clinical practice and is therefore more useful in everyday patient care.

"As the average age of the population continues to rise, it is essential to generate scientific evidence that is genuinely applicable to older patients," said Professor Luigina Guasti. "Evidence-based medicine requires clinical trials that reflect the complexity of this population and take into account not only survival, but also fundamental outcomes such as functional independence, quality of life and patients' preferences. Overcoming the barriers that still limit the participation of older adults in clinical research will ultimately improve the quality of care for millions of people."

In their conclusions, the authors emphasise that the older population will continue to grow rapidly and that clinical research must evolve accordingly. Making clinical trials more inclusive will produce findings that are more reliable and more readily applicable to everyday clinical practice, ultimately improving healthcare and treatment for an ever-growing proportion of the population.