Identifying trials run in India that are registered in other clinical trial registries: a cross-sectional study.

Background: Clinical trials play a crucial role in biomedical research, and it is important to register them in public registries to ensure transparency and prevent research waste. In this study, we wished to determine what steps need to be taken to identify every clinical trial run in India that has been registered in any of the (non-Indian) World Health Organization-recognised primary registries. Of the 16 registries, we studied all except that of the European Union, which will be studied separately.

In Clinical Trials Registry-India, the classification of sponsors needs to be standardised.

Background: In recent years, there has been a big push to register trials, but there are a number of problems with the data in public clinical trial registries. Here, we describe a cross-sectional study of the classification of the primary sponsors of all Phase 2, Phase 2/3, and Phase 3 interventional trials registered with the Clinical Trials Registry-India between May 15, 2016 and May 14, 2021.

Methods: Data was scraped from the records of CTRI, various filters were applied, and the trials of interest identified.

Representation from India in multinational, interventional, phase 2 or 3 trials registered in Clinical Trials Registry-India: A cross-sectional study.

In multinational trials that have run in India, we wished to determine whether there was too much (60% or higher) recruitment from India. We downloaded all trial records from Clinical Trials Registry-India, CTRI, and stored them in a local SQLite database. We queried records registered in a recent 8-year period, ie 2013-2020 and evaluated the fraction of local participants in interventional Phase 2 or Phase 3 studies.

Ethnic representation in interventional clinical trials run in India.

Globally, the need to enhance the diversity of trial participants is receiving increasingly urgent attention. We wanted to know whether trials run in India had adequately sampled the country's enormous ethnic diversity. We accessed the Clinical Trials Registry-India website to determine whether each interventional drug or biologic Phase 2 or 3 study, registered in a recent five-year period had run in each of six geographic zones.

An analysis of deficiencies in the ethics committee data of certain interventional trials registered with the Clinical Trials Registry-India.

There is widespread agreement that clinical trials should be registered in a public registry, preferably before the trial commences. It is also important that details of each trial in the public record are complete and accurate. In this study, we examined the trial sites and ethics committee (EC) data for 1359 recent Phase 2 or Phase 3 interventional trials registered with Clinical Trials Registry-India (CTRI), to identify categories of problems that prevent the clear identification of which EC approved a given site.