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ORIGINAL RESEARCH article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1424570

In India, most Principal Investigators have run very few trials over the years

Provisionally accepted
Rishima Borah Rishima Borah 1Anwesha D. Samanta Anwesha D. Samanta 1Khujith Rajueni Khujith Rajueni 2Vina Vaswani Vina Vaswani 3Gayatri Saberwal Gayatri Saberwal 1*
  • 1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru, India
  • 2 Research Unit of Population Health, Faculty of Medicine, University of Oulu, Oulu, Northern Ostrobothnia, Finland
  • 3 Yenepoya (deemed to be University), Mangaluru, India

The final, formatted version of the article will be published soon.

    Background: 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 3916 unique PI names were associated with 6665 trials. Of these, 2963 (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.

    Keywords: Clinical trial registries, Clinical Trials Registry -India, Interventional trials, trial transparency, Trial ethics, Trial governance, Data quality, Trial participant safety

    Received: 28 Apr 2024; Accepted: 26 Jul 2024.

    Copyright: © 2024 Borah, Samanta, Rajueni, Vaswani and Saberwal. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Gayatri Saberwal, Institute of Bioinformatics and Applied Biotechnology, Bengaluru, India

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.