Bhalla Iqbal S, Ravindranath Adithi Gopadi, Vaswani Ravi, Saberwal Gayatri
School of Geography and the Environment, Oxford University, Oxford, United Kingdom.
Department of Biotechnology, PES University, Bengaluru, India.
Front Med (Lausanne). 2024 Feb 15;11:1346208. doi: 10.3389/fmed.2024.1346208. eCollection 2024.
In India, regulatory trials, which require the drug regulator's permission, must be registered with the Clinical Trials Registry-India (CTRI) as of 19 March 2019. In this study, for about 300 trials, we aimed to identify the CTRI record that matched the trial for which the regulator had given permission. After identifying 'true pairs', our goal was to determine whether the sites and Principal Investigators mentioned in the permission letter were the same as those mentioned in the CTRI record.
We developed a methodology to compare the regulator's permission letters with CTRI records. We manually validated 151 true pairs by comparing the titles, the drug interventions, and the indications. We then examined discrepancies in their trial sites and Principal Investigators.
Our findings revealed substantial variations in the number and identity of sites and Principal Investigators between the permission letters and the CTRI records.
These discrepancies raise concerns about the accuracy and transparency of regulatory trials in India. We recommend easier data extraction from regulatory documents, cross-referencing regulatory documents and CTRI records, making public the changes to approval letters, and enforcing oversight by Institutional Ethics Committees for site additions or deletions. These steps will increase transparency around regulatory trials running in India.
在印度，自2019年3月19日起，需要药品监管机构批准的注册试验必须在印度临床试验注册中心（CTRI）进行注册。在本研究中，针对约300项试验，我们旨在识别与监管机构已批准试验相匹配的CTRI记录。在识别出“真实配对”后，我们的目标是确定批准信中提及的试验地点和主要研究者是否与CTRI记录中提及的一致。
我们开发了一种方法来比较监管机构的批准信与CTRI记录。通过比较标题、药物干预措施和适应症，我们手动验证了151对真实配对。然后，我们检查了它们在试验地点和主要研究者方面的差异。
我们的研究结果显示，批准信与CTRI记录之间在试验地点数量和身份以及主要研究者方面存在显著差异。
这些差异引发了对印度注册试验准确性和透明度的担忧。我们建议更轻松地从监管文件中提取数据，交叉引用监管文件和CTRI记录，公开批准信的变更，并由机构伦理委员会对试验地点的增减进行监督。这些措施将提高印度正在进行的注册试验的透明度。
