What is it about?
Each clinical trial is represented by one record in a clinical trial registry. That record has many details about that trial. It is important that the data in the record be accurate, and the record complete. After examining many records in the Indian registry, Clinical Trials Registry-India (CTRI), we found 30 categories of problems with the data pertaining to the Ethics Committees (that approve a trial). Some of these problems pertain to an individual record. Other problems would arise if one wrote a programme to analyze a large number of records. If these problems were to be fixed, it will raise user confidence in CTRI Ethics Committee data.
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Why is it important?
(a) It is important that data be accurate, so that policies for public health are based on solid data. (b) It is important to build and maintain trust in the clinical trial enterprise. Good data contributes to increased transparency, and trust, in clinical trials. By way of an example: The phenomenon of vaccine hesitancy arose due to a breakdown in trust in the medical enterprise. Unvaccinated individuals created a risk for themselves, but also for those who were vaccinated. Likewise, if there is a breakdown of trust in the system of clinical trials, then no new drugs or vaccines, for instance, would ever be developed.
Perspectives
Where there is a lot of data, there tend to be mistakes! Trial registries have lots of data, and are therefore prone to problems with the data. All registries need to implement systems (with as many automated checks as possible) to minimize such errors.
Gayatri Saberwal
Institute of Bioinformatics and Applied Biotechnology
Read the Original
This page is a summary of: An analysis of deficiencies in the ethics committee data of certain interventional trials registered with the Clinical Trials Registry–India, PLOS Global Public Health, October 2022, PLOS,
DOI: 10.1371/journal.pgph.0000617.
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