Clinical trial registries: The good, and the not so good.

Clinical trial registries are a vital part of the infrastructure of a robust clinical research ecosystem, itself essential for biomedical translational research. We describe what clinical trial registries are, provide a brief history of the major registries, list the major registries today, mention some of the flaws in these registries, comment on the economics of trial registries, give details of the Indian registry, Clinical Trials Registry - India, and catalogue three examples of research done with data in the Indian registry.

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 India, most principal investigators have run very few trials over the years.

Background: In the past, clinical trials run in India have been the subject of criticism. Among other steps to improve the trial ecosystem, for some time the government limited the number of trials that a Principal Investigator (PI) could run to three at a time. We were interested to know how many trials PIs in India tend to run at a time.

Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register.

Introduction: Clinical trial registries serve a key role in tracking the trial enterprise. We are interested in the record of trials sites in India. In this study, we focused on the European Union Clinical Trial Registry (EUCTR).

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

Introduction: 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.

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.

Rare disease patients in India are rarely involved in international orphan drug trials.

We wished to determine whether rare diseases patients from India had been enrolled in international trials to develop novel orphan drugs. There are two reasons to be interested in this. (a) Different ethnic or racial groups may respond differently to a particular drug.

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.

Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data.

Clinical trial registries such as ClinicalTrials.gov (CTG) hold large amounts of data regarding trials. Drugs for rare diseases are known as orphan drugs (ODs), and it is particularly important that trials for ODs are registered, and the data in the trial record are accurate.

The need for a new keyword - "Trial registry-metaresearch" - to track certain uses of clinical trial registry records.

Public clinical trial registries contain a large amount of information about a large number of trials. Academic researchers have conducted various analyses using such data. However, some of these studies do not concern the medical condition or intervention that is the focus of each trial.

CTRI requirement of prospective trial registration: Not always consistent.

In a clinical trial registry, one determines whether a trial is registered prospectively or retrospectively by comparing the date of registration with the date on which enrollment started. However, in Clinical Trials Registry - India (CTRI), in addition, the top of each record is labelled with the phrase "Trial Registered Prospectively" or "Trial Registered Retrospectively". In examining CTRI records, we have found that (a) although retrospective registration has been disallowed from April 1, 2018, some trials were registered retrospectively; (b) in some cases, enrollment started after registration, even though they were labelled "Trial Registered Retrospectively", which is misleading; and (c) in some cases, the date of first enrollment was modified, changing a retrospective registration to a prospective one, although the label "Trial Registered Retrospectively" persisted.

A comparative analysis of important public clinical trial registries, and a proposal for an interim ideal one.

Background: It is an ethical and scientific obligation to register each clinical trial, and report its results, accurately, comprehensively and on time. The WHO recognizes 17 public registries as Primary Registries, and has also introduced a set of minimal standards in the International Standards for Clinical Trial Registries (ISCTR) that primary registries need to implement. These standards are categorized into nine sections-Content, Quality and Validity, Accessibility, Unambiguous Identification, Technical Capacity, Administration and Governance, the Trial Registration Data Set (TRDS), Partner registries and Data Interchange Standards.

Hidden duplicates: 10s or 100s of Indian trials, registered with ClinicalTrials.gov, have not been registered in India, as required by law.

Background: This study's primary goal was based on the fact that since 15 June 2009 it has been mandatory to register regulatory trials running in India with Clinical Trials Registry-India (CTRI). Were all such trials, registered with ClinicalTrials.gov (CTG) after 2009, that included India as a location, also registered with CTRI? We first had to determine how to correctly identify a trial that was registered in both the registries, but that lacked the relevant secondary ID.

The work, goals, challenges, achievements, and recommendations of orphan medicinal product organizations in India: an interview-based study.

Background: Orphan medicinal products (OMPs) are intended for the diagnosis, prevention, management or treatment of rare diseases (RDs). Each RD affects only a small fraction of the population, and therefore, historically, industry hesitated to undertake relevant research and development (R&D). In response, the governments of many countries came up with orphan drug policies and RD policies which were hugely successful in incentivizing companies to do so.

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

Background: Clinical Trials Registry - India (CTRI) was established in July 2007 and today hosts thousands of trials, a significant fraction of them registered in the last couple of years. We wished to undertake an up-to-date analysis of specific fields of the registered trials. In doing so we discovered problems with the quality of the data, which we describe in this paper.

Some data quality issues at ClinicalTrials.gov.

Background: Clinical trial registries have been established as a form of public accountability. Sponsors ought to register their trials promptly and accurately, but this is not always done. Some of the problems include non-registration of trials, registration of trials with incomplete information, and non-reporting of trial results on time.

The role of patient organizations in the rare disease ecosystem in India: an interview based study.

Background: Rare diseases (RDs) affect a small percentage of the population but can be severely debilitating and life-threatening. Historically, patient groups (PGs) have been the prime movers in raising awareness about these diseases and advocating for national supportive policies. They have also driven relevant research programs.

An Analysis of Sponsors/Collaborators of 69,160 Drug Trials Registered with ClinicalTrials.gov.

Background: Clinical trials have been criticized on various counts. Any attempt to improve how trials are conducted or reported requires--amongst other things--an understanding of the number, the nature and the location of those that sponsor them or collaborate on them. Here we sought to identify the nature and location of each sponsor/collaborator.

In eHealth in India today, the nature of work, the challenges and the finances: an interview-based study.

Background: India is a country with vast unmet medical needs. eHealth has the potential to improve the quality of health care and reach the unreached. We have sought to understand the kinds of eHealth programmes being offered in India today, the challenges they face and the nature of their financing.