Changing landscape of geriatric clinical trials: Analysis of Clinical Trials Registry of India
Year: 2024
Type: article
Abstract: INTRODUCTION With the global geriatric population surging to 13%, understanding their health-care needs becomes imperative.[1] However, their representation in clinical trials remains inadequate due to various challenges.[2] Accurate representation is crucial for effective treatment strategies, especially considering age-related pharmacokinetic and pharmacodynamic variations.[3] This study aims to analyze trends in clinical trials involving geriatric populations in India over the past 15 years. MATERIALS AND METHODS This retrospective study, exempt from the Institutional Ethics Committee review, scrutinized CTRI-registered trials (July 2007–December 2023) involving individuals aged 65 years and above. Utilizing keywords such as “geriatrics,” “elderly,” and “old age,” 275 results were initially retrieved. After excluding 21 irrelevant studies, 254 trials met the inclusion criteria and underwent further analysis. Data extraction encompassed study sites in India, study designs (observational or interventional), therapeutic areas, and funding sources (pharmaceutical sponsored/nongovernment organization (NGO) sponsored/academic self-funded/government funded). Analysis was conducted using SPSS Version 21(IBM Corporation, Armonk, New York, USA). RESULTS Among 63,063 studies registered in the Clinical Trials Registry of India from July 2007 to December 2023, only 254 (0.4%) focused on geriatric populations. Of these, 157 (61.8%) were interventional and 97 were observational studies. Therapeutic studies comprised 112 (44%) of the total, with 76 (30%) aimed at improving geriatric quality of life. Preventive medicine (including vaccines and nutritional screening) accounted for 30 studies, while 28 focused on health education. In addition, 8 studies explored new medical devices for the elderly. Of the therapeutic studies, 22 (19.6%) were AYUSH trials, primarily addressing sleep disturbance and mental health enhancement. Surgical interventions (22 studies) addressed various issues, including bedsores and hip replacement. Neurodegenerative disorders (15 studies), cardiometabolic disorders (15 studies), psychiatric disorders (11 studies), and COVID-19 assessment (10 studies) were significant therapeutic areas. Geographically, geriatric trials were concentrated in Central and Southern India, with Karnataka, Maharashtra, and Tamil Nadu leading. Northern India, particularly New Delhi and Gujarat, followed suit, whereas Eastern India (West Bengal) lagged behind with only 17 (6.6%) studies. Funding sources varied, with 36.2% being self-funded projects and 34.3% sponsored by NGOs. Government funding accounted for 24% of studies, whereas pharmaceutical industry support was limited to 5.5%. DISCUSSION Older adults, aged 65 years and above, often confront a higher prevalence of chronic conditions such as cancer, cardiovascular and metabolic disorders, arthritis, and neurodegenerative diseases, alongside challenges such as urinary incontinence, diminished vision, and hearing loss.[1] Age-related physiological changes, pharmacokinetic and pharmacodynamic changes, polypharmacy, and multimorbidity contribute to increased medication usage, complexity in treatment choices, and heightened vulnerability to adverse effects in the elderly population.[1,4] Despite these complexities, the inclusion of older adults in clinical trials remains insufficient, perpetuating disparities in health-care outcomes.[5] Various barriers hinder their participation, including comorbidities, cognitive impairment, and social isolation.[4,5] Initiatives such as educational programs, policy changes, and increased support for transportation and home visits can help address these challenges.[5] Studies reveal significant underrepresentation of older adults in clinical trials across various medical conditions, limiting the generalizability of findings to this demographic.[6] Regulatory bodies acknowledge the importance of including older individuals in trials to ensure the safety and efficacy of treatments. Addressing the underrepresentation of older adults in clinical research is crucial for generating comprehensive evidence-based guidelines and improving health-care outcomes in aging populations. Adequate representation in clinical trials can enhance the overall well-being and independence of older adults, promoting healthy aging globally. However, it is important to acknowledge the limitations of this study, including the nonmandatory nature of CTRI enrollment for nonregulatory studies till 2017, potentially resulting in incomplete representation of ongoing research. CONCLUSION While the inclusion of geriatric populations in clinical trials is increasing, significant gaps persist. Further research is crucial to address these disparities and improve understanding of geriatric pharmacology. Emphasizing postmarketing surveillance and real-world studies can complement traditional trial phases, ensuring safer and more effective treatments for elderly individuals. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Authors: Abissha Sargunaraj, Jerin James, P. Kala, R. Jamuna Rani
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4402214508