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. RESULTS: Of 5,453 trials, 105 did not identify a sponsor and 1,080 were sponsored by individuals. Of the remaining 4,268 trials, 427 had unique sponsors, and 3,841 had a total of 350 non-unique sponsors. Of the 350 sponsors, 202 were classified in a single category, and 147 were classified in two or more categories. Overall, of the 3,841 trials, sponsors in 3,537 (92.1%) were classified in one or more of nine well-defined categories, and 304 (7.9%) were classified as various versions of "Other". Three major problems with the sponsor data were identified: each trial does not necessarily list a sponsor, a given sponsor may be categorised in multiple ways, and there has been an excessive use of the "Other" category. Addressing these problems will enable automated analyses of the database, and improve the transparency of the data. CONCLUSION: Our study generates evidence highlighting the need to improve the trial registration system in India, and perhaps elsewhere.

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. 62 trials were completed, with completion dates available. Five trials (8%) had 60% or more planned recruitment from India. Four of the five (7% of 62) had a foreign sponsor, and therefore there was an unfair burden-benefit ratio on the Indian population. Seven trials (11%), of which six (10% of 62) had foreign sponsors, had 60% or more (of the total) actual recruitment from India, and for two trials (both with foreign sponsors), the data were meaningless. There were 362 studies that were listed as not completed, although, given their start date and estimated duration, some of them ought to have been. Twenty five cases (7% of 362) had 60% or more planned recruitment from India. Of these, 18 (5% of 362) had foreign sponsors and were potentially problematic. Even allowing for some delays in completion, 128 (35% of 362) studies ought to have been completed by the time of our study. As such, we identified several problematic trials for which the planned recruitment from India in multinational studies was 60% or more. We also identified trials in which the actual recruitment was significantly higher than the planned recruitment. Further, the records of several studies that were probably completed were not updated in CTRI in a timely manner. The Indian drug regulator needs to be particularly alert to the planned, or actual, over-recruitment of participants from India. Further, CTRI, alone or in collaboration with the regulator, needs to ensure that multinational trial records for the enrollment fields in particular are updated, in a timely manner.

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. As regards Phase 3 trials conducted only in India, 61.4% ran in a single zone and just 6.8% were conducted in all six zones. Multinational Phase 3 trials had a better distribution since 3.6% had run in just one zone and 7.1% in all six. India's diverse ethnic groups are underrepresented in the majority of trials covered in this study. A trial that is conducted on non-representative groups and later discovered to be harmful or ineffective in parts of the population, is unethical. We propose various remedial steps.

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. 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.