Kaur Rimplejeet, Charan Jaykaran, Reljic Tea, Singh Surjit, Bhardwaj Pankaj, Tsalatsanis Athanasios, Kumar Ambuj
Department of Pharmacology, S. N. Medical College, Jodhpur, Rajasthan, India.
Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India.
J Pharm Bioallied Sci. 2020 Jul-Sep;12(3):269-276. doi: 10.4103/jpbs.JPBS_197_19. Epub 2020 Jul 18.
Research output/efforts in a country should be reflective of the disease burden. India is a site for several national and multinational clinical trials. However, whether clinical trials performed in India reflect the disease burden is not well known.
The aim of this study was to evaluate the relationship between disease burden and clinical trials performed in India.
We extracted data on the disease burden from the World Health Organization (WHO) website and on characteristics of clinical trials performed in India from the Clinical Trial Registry of India (CRTI). The correlation between disease burden parameters of overall mortality, disability-adjusted life years (DALYs), years lost due to disability (YLD) and years of life lost (YLL), and the frequency of clinical trials associated with a particular disease was assessed. Additional subgroup analysis according to the number of trial centers, study phase, and medicine type was also performed.
Only 18% of clinical trials addressed top 10 diseases associated with 68.3% of overall mortality, and 8% of clinical trials addressed top 10 diseases associated with 52.3% of DALYs. Similarly, 16% of clinical trials addressed top 10 diseases associated with 53.2% YLDs. Furthermore, top 10 diseases associated with 65.9% of YLLs were addressed in only 8% of ongoing clinical trials. The overall correlation between any disease burden parameters with the diseases being explored in clinical trials was poor.
There is a mismatch between diseases for which clinical trials are happening in the India and the disease burden of India. Measures need to be taken to fulfill this gap between demand and need.
一个国家的研究产出/成果应反映疾病负担情况。印度是多个国内和国际临床试验的开展地。然而，在印度进行的临床试验是否反映了疾病负担尚不清楚。
本研究旨在评估印度疾病负担与所开展的临床试验之间的关系。
我们从世界卫生组织（WHO）网站提取了疾病负担数据，并从印度临床试验注册中心（CRTI）提取了在印度进行的临床试验的特征数据。评估了总体死亡率、伤残调整生命年（DALYs）、因残疾损失的年数（YLD）和生命损失年数（YLL）等疾病负担参数与特定疾病相关临床试验频率之间的相关性。还根据试验中心数量、研究阶段和药物类型进行了额外的亚组分析。
仅18%的临床试验针对与68.3%的总体死亡率相关的前10种疾病，8%的临床试验针对与52.3%的伤残调整生命年相关的前10种疾病。同样，16%的临床试验针对与53.2%的因残疾损失的年数相关的前10种疾病。此外，仅8%的正在进行的临床试验针对与65.9%的生命损失年数相关的前10种疾病。临床试验中所探索疾病与任何疾病负担参数之间的总体相关性较差。
印度正在进行临床试验的疾病与印度的疾病负担之间存在不匹配。需要采取措施来填补这一需求与实际情况之间的差距。
