Borah Rishima, Samanta Anwesha Dhal, Rajueni Khujith, Vaswani Vina, Saberwal Gayatri
Institute of Bioinformatics and Applied Biotechnology, Bengaluru, India.
Research Unit of Population Health, Faculty of Medicine, University of Oulu, Oulu, Finland.
Front Med (Lausanne). 2024 Aug 7;11:1424570. doi: 10.3389/fmed.2024.1424570. eCollection 2024.
In 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.
We 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.
We 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.
Each 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.
过去，在印度开展的临床试验一直备受批评。在改善试验生态系统的诸多举措中，有一段时间政府将主要研究者（PI）一次能够开展的试验数量限制为三项。我们想了解印度的主要研究者一次倾向于开展多少项试验。
我们获取了2023年4月由印度临床试验注册中心托管的52149条试验记录。其中，我们筛选出在印度开展的、属于干预性且涉及某些干预措施（如药物、生物制品等）的试验。我们使用多个参数，如电子邮件地址、电话号码等，来确定一个名字是否始终代表同一个主要研究者，以及两个名字是否对应同一个主要研究者。然后我们确定每个主要研究者开展了多少项试验。
我们发现3916个不同的主要研究者名字与6665项试验相关。其中，2963名（75.7%）主要研究者仅开展了一项研究。只有251名（6.4%）开展了三项以上试验。仅有14名主要研究者开展了20项或更多试验。这14名主要研究者分别隶属于当地制药公司（6名）、当地或全球合同研究组织（4名）、跨国制药公司（3名）以及顺势疗法中央研究理事会（1名）。单个主要研究者开展的试验最多为108项。其中，2022年单年开展的试验最多，为53项。
每个主要研究者名字都需要与一个不会随时间变化的唯一标识符相关联，以便更轻松地追踪特定主要研究者开展的试验数量。特定主要研究者在特定时间开展的研究数量不应过多，需要更积极地进行监测。政府需要考虑是否需要对主要研究者一次开展的试验数量设置上限，以及需要具备哪些基础设施来便利开展更多试验。试验注册记录需要更定期地更新。其他国家可能也希望如此。
