Changing landscape of geriatric clinical trials: Analysis of Clinical Trials Registry of India

Abstract

Abstract Background: Approximately 13% of the world’s population is more than 65 years old, and they consume major proportion of all medicinal products. Geriatric population constitute the majority of patients for chronic conditions including cardiac disease, malignancies, metabolic disorders, neurodegenerative disorders among others. However, in clinical trials, the elderly population is not adequately represented. In clinical studies, age-related physiological changes that impact the drug’s pharmacokinetics and pharmacodynamics in the elderly are not adequately assessed. Additionally, concomitant medications and comorbid conditions make elderly individuals more vulnerable to side effects. Objective: To analyse the trends of clinical trials involving the geriatric population in India over the past 16 years registered under Clinical Trial Registry of India. Materials and Methods: All clinical trials registered under CTRI from July 2007 to December 2023 were reviewed and analyzed using the key words “geriatrics”, “elderly”, “old age” in the ‘trial search’ section. Data was extracted for the year of study, type of trial, therapeutic area and sites of study. Results: Out of a total of 63,063 studies were registered in CTRI, 254 studies (0.37%) had geriatric population in their inclusion criteria. Of these studies 157 studies (61.8%) were interventional in nature. 29.9% of the studies were related to improvement in quality of life in the elderly. Regulatory clinical trials which included geriatrics to evaluate the efficacy and safety of drugs were only 5.5%. A gradual increase in the number of trials including elderly population was noted over the last 5 years. Conclusion: There is a major dearth of clinical trials that evaluate the geriatric population. However, there is an increasing trend of inclusion of geriatric population in clinical trials over the recent years.