Representation from India in multinational, interventional, phase 2 or 3 trials registered in Clinical Trials Registry-India: A cross-sectional study
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SUBMITTER: Mendiratta J
PROVIDER: S-EPMC10511072 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundClinical 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.MethodsWe downloaded CTRI records and reformatted the data into an SQLite database, which we then queried. We also accessed ClinicalTrials.gov records as needed.ResultsWe 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.ConclusionsIt 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.
| S-EPMC6712861 | biostudies-literature
Project description: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.
| S-EPMC10021301 | biostudies-literature
Project description:Summary 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.
| S-EPMC10442962 | biostudies-literature
Project description:BackgroundInterventional clinical trials for infectious diseases in old population have arisen much attention in recent years, however, little is known about the characteristics of registered clinical trials regarding this field. This study aimed to investigate the characteristics of registered interventional trials for infectious diseases in old populations on ClinicalTrials.gov.MethodsA cross-sectional study was performed. We used viral OR bacterial OR fungal OR parasitic OR infectious disease to search the ClinicalTrials.gov database and to assess characteristics of included trials. The age of participants was restricted to more than 65 years old. All analyses were performed using the SPSS19.0 software.ResultsA total of 138 registered trials were included. Among them, 105(76.1%) trials were completed; however, the results were available in ClinicalTrials.gov for only 44(31.9%) trials. North America was the most frequently identified study location (52.9%), followed by Europe (30.4%) and Asia (11.6%). Seventy-one percent trials focused on viral pathogens, followed by bacterial pathogens (22.5%). A total of 84.1% trials were prevention oriented. A total of 84.1% trials used randomization, 73.2% trials used parallel assignment, and 64.5% used masking. Eighty-six trials were industry-funded and 52 were non-industry-funded. Industry-funded trials had higher percentages than non-industry-funded trials in available results, prevention trial, and phase 2 and phase 3 trial, and lager sample size trial. One hundred eleven trials were vaccine trials and 27 trials were non-vaccine trials. Vaccine trials had higher percentages than non-vaccine trials in available results, leading industry sponsor and viral etiology.ConclusionsThe current study is the first study of the landscape of interventional clinical trials for infectious diseases in old populations registered in ClinicalTrials.gov, providing the basis for treatment and prevention of infectious diseases in old populations. Trials in this field are still relatively lacking, and additional and better trials are needed.
| S-EPMC7333184 | biostudies-literature
Project description:BackgroundElderly patients represent the greatest consumers of healthcare per capita but have historically been underrepresented in clinical trials. It is unknown how many trials are designed to focus exclusively on elderly patients.ObjectiveTo define the prevalence of interventional trials that study exclusively elderly persons and describe the characteristics of these trials, including their distribution across conditions most prevalent in the elderly.DesignAll interventional clinical trials enrolling exclusively elderly patients (≥65 years), conducted primarily in high-income countries, and initiated between 2006 and 2014, identified through ClincialTrials.gov.Main measuresTrials were identified and characterized according to design features and disease categories studied. Across disease categories we examined the burden of disease in the elderly in high-income countries (measured in disability-adjusted life years [DALYs]) and compared to the number of trials conducted exclusively in the elderly.ResultsAmong 80,965 interventional trials, 1,112 (1.4%) focused on elderly patients. Diverse types of interventions were studied in these trials (medications 33%, behavioral interventions 18%, and dietary supplements 10%) and the majority was funded by non-profit organizations (81%). Studies tended to be small (median sample size 122 participants [IQR 58, 305]), single-center studies (67%). Only 43% of 126 disease categories affecting elderly persons were studied in trials focused on the elderly. Among these disease categories, there was a 5162-fold range in the ratio of DALYs per trial. Across 5 conditions where over 80% of DALYs are in the elderly, there were a total of only 117 trials done exclusively in the elderly.ConclusionsVery few and mostly small studies are conducted exclusively in elderly persons, even for conditions that affect almost exclusively the elderly.
| S-EPMC4873036 | biostudies-literature
Project description:Since the beginning of the year, the deadly coronavirus pandemic, better known as coronavirus disease 2019 (COVID-19), brought the entire world to an unprecedented halt. In tandem with the global scenario, researchers in India are actively engaged in the conduct of clinical research to counter the pandemic. This review attempts to provide a comprehensive overview of the COVID-19 research in India including design aspects, through the clinical trials registered in the Clinical Trials Registry - India (CTRI) till June 5, 2020. One hundred and twenty two registered trials on COVID-19 were extracted from the CTRI database. These trials were categorized into modern medicine (n=42), traditional medicine (n=67) and miscellaneous (n=13). Of the 42 modern medicine trials, 28 were on repurposed drugs, used singly (n=24) or in combination (n=4). Of these 28 trials, 23 were to evaluate their therapeutic efficacy in different severities of the disease. There were nine registered trials on cell- and plasma-based therapies, two phytopharmaceutical trials and three vaccine trials. The traditional medicine trials category majorly comprised Ayurveda (n=45), followed by homeopathy (n=14) and others (n=8) from Yoga, Siddha and Unani. Among the traditional medicine category, 31 trials were prophylactic and 36 were therapeutic, mostly conducted on asymptomatic or mild-to-moderate COVID-19 patients. This review would showcase the research being conducted on COVID-19 in the country and highlight the research gaps to steer further studies.
| S-EPMC8184082 | biostudies-literature
Project description:BackgroundClinical 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.MethodsTwo methodologies were employed for each registry, except for four that did not facilitate one or the other method. Methodology A involved downloading all the records in a registry and querying them. Methodology B involved conducting a search via the registry website.ResultsOnly four registries provided consistent results with both methodologies. Seven registries had different results from the two methodologies. Of these, in four cases, in Methodology A one field indicated that the study ran in India, while another indicated otherwise.ConclusionsThe above-mentioned ambiguities should be addressed by the concerned registries. Overall, this study reinforces the need for improved data accuracy and transparency in clinical trial registries and emphasizes the importance of resolving complications faced by users while navigating the registries. Ensuring accurate and comprehensive registration of clinical trials is essential for meta-research and the use of such data by a variety of stakeholders.
| S-EPMC11391788 | biostudies-literature
Project description:BackgroundTimely publication of clinical trials is critical to ensure the dissemination and implementation of high-quality healthcare evidence. This study investigates the publication rate and time to publication of randomized controlled trials (RCTs) registered in the Australian New Zealand Clinical Trials Registry (ANZCTR).Materials and methodsWe conducted a cross-sectional study of RCTs registered with the ANZCTR in 2007, 2009, and 2011. Multiple bibliographic databases were searched until October 2021 to identify trial publications. We then calculated publication rates, proportions, and the time to publish calculated from the date of first participation enrolment to publication date.ResultsOf 1,970 trial registrations, 541 (27%) remained unpublished 10 to 14 years later, and the proportion of trials published decreased by 7% from 2007 to 2011. The average time to publish was 4.63 years. The prospective trial registration rate for 2007, 2009 and 2011 was 48% (952 trials) and over this time there was an increase of 19% (280 prospective trials). Trials funded by non-Industry organizations were more likely to be published (74%, 1204/1625 trials) than the industry-funded trials (61%, 224/345 trials). Larger trials with at least 1000 participants were published at a rate of 88% (85/97 trials) and on average took 5.4 years to be published. Smaller trials with less than 100 participants were published at a lower rate with 67% (687/1024 trials) published and these trials took 4.31 years on average to publish.ConclusionsJust over a quarter of all trials on the ANZCTR for 2007, 2009, and 2011 remain unpublished over a decade later. The average time to publication of nearly five years may reflect the larger trials which will have taken longer to recruit participants. Over half of study sample trials were retrospectively registered, but prospective registration improved over time, highlighting the role of mandating trial registration.
| S-EPMC9815633 | biostudies-literature
Project description:BackgroundThe Clinical Trials Registry-India (CTRI) is an initiative of the Indian Council of Medical Research, New Delhi, India (ICMR) and monitored by the ICMR-National Institute of Medical Statistics (NIMS) since July 20, 2007. Randomized clinical trials are considered as the gold standard in evidence-based medicine. Registration of clinical trials enables disseminating evidence among clinicians, researchers, and patients. It promotes transparency and avoids duplication. The registration process is mandatory for AYUSH clinical trials also.ObjectivesThis analysis is aimed to determine the different characteristics of registered AYUSH clinical trials in CTRI from 2009 to 2020.Materials and methodsA cross-sectional retrospective analysis was conducted. The information on registered clinical trials about AYUSH was obtained from the website www.ctri.nic.in from 2009 to 2020 (n = 3632; last accessed on July 30 2020). Data analysis considered the following factors for analysis using descriptive statistics. The number of clinical trials registered in AYUSH stream were classified according to registration type (retrospective/prospective), postgraduate dissertations (yes/no), primary sponsor, type of trial (interventional/observational), study design, health condition and State-wise distribution of sites of studies.ResultsThe number of clinical trial registrations among AYUSH streams (3632) descends from Ayurveda (2054), followed by Siddha (635), Yoga (408), Unani (366) and Homoeopathy (169). Interventional studies dominate observational studies among all AYUSH registered trials. AYUSH streams took four years to register in CTRI due to an increase in reporting trials from 2013. Significant number of trials were registered retrospectively. The order of closure of retrospective registration has influenced an increase in prospective enrolment between 2017-2019.ConclusionRegistration of clinical trials in the CTRI should be encouraged. Randomized controlled trials (RCTs) occupy a rear seat which exposes an opportunity for trials and alarms about weak trials. Non-communicable diseases (NCDs) are registered more comparatively, which reflects the strength of AYUSH in NCDs. Most of the trials fall under phase 2, which seems to have an increasing opportunity for more trials. Certain visible flaws like registering Phase 2 trials as Phase 3 or 4 and domestic trials as international trials reflect human resources crunch in ICMR-CTRI in Issuing Certificates. These errors should be rectified by training the stakeholders effectively.
| S-EPMC8185998 | biostudies-literature
Project description:Background/aimsThe registry ClinicalTrials.gov was created to provide investigators and patients an accessible database of relevant clinical trials.MethodsTo understand the state of sickle cell disease clinical trials, a comprehensive review of all 174 "closed," "interventional" sickle cell trials registered at ClinicalTrials.gov was completed in January 2015.ResultsThe majority of registered sickle cell disease clinical trials listed an academic center as the primary sponsor and were an early phase trial. The primary outcome for sickle cell disease trials focused on pain (23%), bone marrow transplant (BMT) (13%), hydroxyurea (8%), iron overload (8%), and pulmonary hypertension (8%). A total of 52 trials were listed as terminated or withdrawn, including 25 (14% of all trials) terminated for failure to enroll participants. At the time of this review, only 19 trials uploaded results and 29 trials uploaded a manuscript in the ClinicalTrials.gov database. A systematic review of pubmed.gov revealed that only 35% of sickle cell studies completed prior to 2014 resulted in an identified manuscript. In comparison, of 80 thalassemia trials registered in ClinicalTrials.gov, four acknowledged failure to enroll participants as a reason for trial termination or withdrawal, and 48 trials (60%) completed prior to 2014 resulted in a currently identified manuscript.ConclusionClinicalTrials.gov can be an important database for investigators and patients with sickle cell disease to understand the current available research trials. To enhance the validity of the website, investigators must update their trial results and upload trial manuscripts into the database. This study, for the first time, quantifies outcomes of sickle cell disease trials and provides support to the belief that barriers exist to successful completion, publication, and dissemination of sickle cell trial results.
| S-EPMC4643416 | biostudies-literature