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

Abstract

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. We created an SQLite database that hosted the relevant CTRI records, and queried this database, as needed. We identified two broad categories of problems: those pertaining to the understanding of an individual trial and those to adopting a data analytics approach for a large number of trials. Overall, about 30 problems were identified, such as an EC not being listed; an uninformative name of the EC that precluded its clear identification; ambiguity in which EC supervised a particular site; repetition of a site or an EC; the use of a given acronym for different organizations; site name not clearly listed, etc. The large number of problems with the data in the EC or site field creates a challenge to link particular sites with particular ECs, especially if a programme is used to find the matches. We make a few suggestions on how the situation could be improved. Most importantly, list the EC registration number for each EC, merge the site and EC tables so that it is clear which EC is linked to which site; and implement logic rules that would prevent a trial from being registered unless certain conditions were met. This will raise user confidence in CTRI EC data, and enable data based public policy and inferences. This will also contribute to increased transparency, and trust, in clinical trials, and their oversight, in India.

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

“…Although we did not encounter this in our sample of trials, another potential issue relates to ambiguity in sponsor [6] acronyms. There are several All India Institutes of Medical Sciences in the country, all of which are abbreviated as AIIMS; at least five organisations, the Kalinga, Karnataka, Kerala, and Krishna Institutes of Medical Sciences and the Kempegowda Institute of Medical Sciences Hospital, share the acronym KIMS [31]. This could complicate an analysis, since it might then require an examination of the address field to identify the sponsor.…”

Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match

“…Such issues have been recorded for other registries as well, primarily ClinicalTrials.gov, of the United States, which is by far the biggest (5) and clearly the most studied of the public registries. In our own work, we have identified such issues in various fields of the CTRI records (6)(7)(8). Researchers around the world have been concerned about such issues (9)(10)(11).…”