ABSTRACT
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.
Subject(s)
Cross-Sectional Studies , Humans , India , Registries , Clinical Trials as TopicABSTRACT
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.
ABSTRACT
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. METHODS: We downloaded CTRI records and reformatted the data into an SQLite database, which we then queried. We also accessed ClinicalTrials.gov records as needed. RESULTS: We discovered various categories of problems with the data in the CTRI database, including (1) a lack of clarity in the classification of Types of Study, (2) internal inconsistencies, (3) incomplete or non-standard information, (4) missing data, (5) variations in names or classification, and (6) incomplete or incorrect details of ethics committees. For most of these problems, error rates have been calculated, over time. Most were found to be in single digits, although others were significantly higher. We suggest how data quality in future editions of CTRI could be improved, including (1) a more elaborate and structured way of classifying the Type of Study, (2) the use of logic rules to prevent internal inconsistencies, (3) less use of free text fields and greater use of drop-down menus, (4) more fields to be made compulsory, (5) the pre-registration of individuals' and organizations' names and their subsequent selection from drop-down menus while registering a trial, and (6) more information about each ethics committee, including (a) its address and (b) linking the name of the trial site to the relevant ethics committee. As we discuss problems with the data of specific fields, we also examine - where possible - the quality of the data in the corresponding fields in ClinicalTrials.gov, the largest clinical trial registry in the world. CONCLUSIONS: It is a scientific and ethical obligation to correctly record all information pertaining to each trial run in India. CTRI is a valuable database that has proved its worth in terms of improving the record of trials in the country. The suggestions made herein would improve it further.
