Table_2_In India, most principal investigators have run very few trials over the years.XLSX

BackgroundIn the past, clinical trials run in India have been the subject of criticism. Among other steps to improve the trial ecosystem, for some time the government limited the number of trials that a Principal Investigator (PI) could run to three at a time. We were interested to know how many trials PIs in India tend to run at a time.
MethodsWe accessed the 52,149 trial records hosted by the Clinical Trials Registry—India in April 2023. Of these, we shortlisted trials that had run in India, were interventional, and involved certain interventions such as drug, biological etc. We used multiple parameters, such as email ID, phone number etc. to determine whether one name always represented the same PI and whether two names corresponded to the same PI. We then determined how many trials each PI had run.
ResultsWe found that 3,916 unique PI names were associated with 6,665 trials. Of these, 2,963 (75.7%) PIs had run a single study. Only 251 (6.4%) had run more than three trials. A mere 14 PIs had run 20 or more trials. The 14 PIs were affiliated with local pharma companies (6), local or global contract research organizations (4), multinational pharma companies (3) and the Central Council for Research in Homeopathy (1). The maximum number of trials run by a single PI was 108. Of these, the largest number run in a single year, 2022, was 53.
ConclusionEach PI name needs to be connected to a unique ID that does not change with time, so that it is easier to track the number of trials that a given PI has run. The number of studies run by a given PI at a given time must not be excessive and needs to be monitored more actively. The government needs to consider whether a cap on the number of trials that a PI runs at a time is required and what infrastructure needs to be in place to facilitate higher numbers of trials. Trial registry records need to be updated more regularly. Other countries may wish to do likewise.

背景 过往印度开展的临床试验曾饱受诟病。为完善临床试验生态体系，印度政府曾在一段时间内规定，每位主要研究者（Principal Investigator, PI）同期开展的临床试验数量不得超过3项。本研究旨在了解印度的主要研究者通常同期开展多少项临床试验。

方法 本研究于2023年4月调取了印度临床试验注册库（Clinical Trials Registry—India）收录的52149条临床试验记录。从中筛选出在印度开展的干预性临床试验，且涉及药物、生物制品等干预措施的记录。我们通过电子邮箱、电话号码等多个参数，判断同一姓名是否始终对应同一位主要研究者，以及不同姓名是否指向同一位主要研究者。随后统计每位主要研究者开展的临床试验数量。

结果 本研究共识别出3916个唯一的主要研究者姓名，对应6665项临床试验。其中2963位（75.7%）主要研究者仅开展过1项临床试验。仅251位（6.4%）主要研究者开展过3项以上的临床试验。仅有14位主要研究者开展过20项及以上的临床试验。这14位主要研究者分别隶属于本土制药企业（6位）、本土或全球合同研究组织（4位）、跨国制药企业（3位）以及中央顺势疗法研究委员会（Central Council for Research in Homeopathy）（1位）。单一位主要研究者开展的临床试验数量最高为108项。其中2022年是单一年度开展临床试验数量最多的年份，达53项。

结论 每位主要研究者的姓名应绑定唯一且永久有效的身份标识，以便更便捷地追踪某位研究者开展的临床试验数量。研究者同期开展的临床试验数量不应过多，需加强主动监测。印度政府应考虑是否需要对研究者同期开展的临床试验数量设置上限，并规划配套基础设施以支持更多临床试验的开展。临床试验注册库的记录需更定期地更新。其他国家亦可借鉴此经验。