Indian Interventional trials for COVID-19 drugs: Insights and Learnings

  1. Arati Ranade
  2. Kirtee Wani
  3. V. Premnath
  4. Chitra Lele
  5. Smita Kale

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Abstract

Since the COVID-19 pandemic began, India has substantially contributed to drug development and clinical research. Task Force on Repurposing of Drugs (TFORD) for COVID19 has tried to look at the overall position of India in terms of interventional clinical trials and highlight learnings which can prepare us to fight future pandemics in a better way. Trials registered on CTRI from March 2020 to December 2020 were considered for this purpose. From a total 409 trials registered, 108 focused on modern drugs. From 108 trials studied, 92 were randomized trials, 34 trials were sponsored by Indian Pharmaceutical industry, 23 were self-sponsored and 20 were sponsored by Research institutes and hospitals. Only 83 trials studied the repurposed drugs. An unfortunate revelation was that out of 108 trials, 79 showed as not yet recruiting. This highlights the urgent need for Government, Research institutions and Indian Pharmaceutical industries to break down silos and work together towards this common cause.

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  1. ScreenIT

    SciScore for 10.1101/2021.05.16.21257299: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.05.16.21257299v1 on medRxiv