Sharma Avi Anil, Karekar Sonali Rajiv, Shetty Yashashri Chandrakant
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
J Midlife Health. 2021 Jan-Mar;12(1):61-65. doi: 10.4103/jmh.jmh_254_20. Epub 2021 Apr 17.
The elderly in India form a heterogeneous subset of the population with significant disease burden variations. However, there are no data available regarding the type of research studies conducted in an elderly population in India.
The aim of this study was to analyze the research studies conducted in the elderly population in India based on data from the Clinical Trials Registry of India (CTRI).
This was an "audit" of available data on the CTRI website.
Following exemption from the Institutional Ethics Committee, all studies in the elderly population registered in CTRI from its inception (July 2007 to August 2019) were reviewed. Data captured with respect to geographical distribution, study designs used, therapy area, trial registration, and funding.
The variables were analyzed using descriptive statistics using SPSS version 16.0.
Out of a total of 21,400 studies in CTRI, a total of 99 (0.46%) studies involved only elderly patients. Of these studies, 60 (60.6%) were interventional, whereas 39 (39.4%) were observational. Of all the interventional studies, 17 (28%) tested drugs, 26 (43%) tested a lifestyle intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and physiotherapy. Postgraduate theses constituted 60 (60.6%) studies. Eighty-seven (87.9%) were academic projects, eight (8.1%) were government-funded studies, and only four (4%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was the central nervous system, followed by community medicine and orthopedics.
This study depicts the underrepresentation of the geriatric population in clinical studies.
印度的老年人群是人口中的一个异质性亚组，疾病负担差异显著。然而，目前尚无关于印度老年人群所开展研究类型的数据。
本研究旨在基于印度临床试验注册中心（CTRI）的数据，分析在印度老年人群中开展的研究。
这是对CTRI网站上可用数据的一项“审核”。
经机构伦理委员会豁免后，对CTRI自成立（2007年7月至2019年8月）以来登记的所有老年人群研究进行了回顾。收集了有关地理分布、所采用的研究设计、治疗领域、试验注册和资金来源的数据。
使用SPSS 16.0版本的描述性统计对变量进行分析。
在CTRI总共21400项研究中，共有99项（0.46%）研究仅涉及老年患者。在这些研究中，60项（60.6%）为干预性研究，而39项（39.4%）为观察性研究。在所有干预性研究中，17项（28%）测试药物，26项（43%）测试生活方式干预，其余为营养保健品、阿育吠陀、瑜伽与自然疗法、尤那尼、悉达、顺势疗法以及物理治疗。研究生论文构成了60项（60.6%）研究。87项（87.9%）为学术项目，8项（8.1%）为政府资助研究，仅有4项（4%）为制药公司赞助的研究。研究最多的治疗领域是中枢神经系统，其次是社区医学和骨科。
本研究表明老年人群在临床研究中的代表性不足。
