Chaturvedi Mansi, Gogtay Nithya J, Thatte Urmila M
Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Perspect Clin Res. 2017 Oct-Dec;8(4):172-175. doi: 10.4103/2229-3485.215970.
India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India.
All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the "Trial Search" section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs) in that area taken from Global Health Estimates [2014] Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011].
A total of 6474 studies were registered of which 3325 (51.4%) were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka (11.6%) and Tamil Nadu (10%). Populous states like Uttar Pradesh (5.3%) and Bihar (1.4%) had far fewer trials. The largest number of trials was in the area of cancer (16.4%), followed by diabetes (12.1%) and cardiovascular diseases (10.1%). Infectious and parasitic diseases had the highest DALYs (82,681) and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%), but ranked 6th based on DALYs.
Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most.
印度在全球疾病负担中所占比例仍然过高，而且印度的公共卫生研究产出也与其医疗保健需求不相称。我们开展了本研究，通过审核印度临床试验注册库来评估临床试验是否符合该国的医疗保健需求。
在“试验搜索”板块中搜索了2007年7月20日至2015年12月31日期间在印度临床试验注册库（CTRI）注册的所有临床研究。评估了研究的总数、研发阶段和治疗领域。将每个治疗领域的试验与取自世界卫生组织《2014年全球卫生估计》汇总表中该领域的疾病负担（伤残调整生命年）进行了比较。还将印度每个邦开展的试验数量与该邦的人口数量（2011年人口普查数据）进行了比较。
共注册了6474项研究，其中3325项（51.4%）为临床试验。马哈拉施特拉邦的试验数量最多[16.4%]，其次是卡纳塔克邦（11.6%）和泰米尔纳德邦（10%）。像北方邦（5.3%）和比哈尔邦（1.4%）这样的人口大省的试验数量则少得多。试验数量最多的领域是癌症（16.4%），其次是糖尿病（12.1%）和心血管疾病（10.1%）。传染病和寄生虫病的伤残调整生命年最高（82,681），在疾病负担中排名第一，但仅占试验总数的5%，按试验数量排名第7。癌症的试验数量排名第一（16.4%），但按伤残调整生命年排名第6。
在印度开展的临床试验与其医疗保健需求不一致。有必要加强人口大省和该国东北部地区的试验开展能力，以便更公平地选择参与者。政府应出台政策，鼓励在最需要的领域开展新药研发。
