Clinical Trials Registry - India: Redefining the conduct of clinical trials

Pandey, Arvind; Ar, Aggarwal; Seth, S D; Maulik, Mohua; Bano, Rafia; Juneja, Atul

doi:10.4103/0019-509x.44060

Cited by 30 publications

(28 citation statements)

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“…Thus, in order to practice EBP, complete documentation of these clinical trials is essential which is of great concern in recent times. [2] The Food and Drug Administration reports inability to track bioresearch due to nonmaintenance and nonregistration of clinical trials. [3] As EBP is the need of the hour, registering and publishing the available research data becomes obligatory.…”

Section: Introductionmentioning

confidence: 99%

“…It registers all the trials and links it to World Health Organization International clinical trial registry platform where quality assurance is ensured and increases the certainty for availability for EBP. [2] Studies have publicized that the reporting of clinical trials is poor in dentistry. [4] Hence, the present study was conducted to assess the methodological design and trends of clinical trials that are being undertaken in the field of dentistry in India over a span of 6 years.…”

Section: Introductionmentioning

confidence: 99%

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Clinical trials in dentistry in India: Analysis from trial registry

Sivaramakrishnan

Sridharan

2017

Perspect Clin Res

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Introduction:Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years.Methodology:All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword “dental.” Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time.Results:The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published.Conclusion:The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical trials in dentistry in India: Analysis from trial registry

Sivaramakrishnan

Sridharan

2017

Perspect Clin Res

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“…The contract research and manufacturing services are ever increasing in India. [4][5][6][7] Due to this changing scenario, it becomes mandatory to explore whether these increase in randomized clinical trials in India have led to the availability of new drugs to Indian population. This study analyzed the relationship between the number of randomized clinical trial conducted and subsequent new drug approvals in India and USA.…”

Section: Introductionmentioning

confidence: 99%

Analysis of randomized clinical trials leading to new drug approvals in India and USA

et al. 2016

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Background:To analyse the number of randomized clinical trials and subsequent new drug approvals in India and USA.Methods: Data was collected for completed randomized clinical trials done by multinational in India and USA from www.clinicaltrials.gov during the period from 1/1/2009 to 31/08/2014 and the subsequent new drug approvals from 1/1/2010 to 31/10/2015 for India obtained from Central Drugs Standard Control Organization (CDSCO) (www.cdsco.nic.in.) website and for USA obtained from United States Food and Drug Administration (USFDA) (www.fda.gov) website. Results were measured in terms of percentage of completed randomized clinical trials for investigational medicinal products (IMP) leading to new drugs approvals in India and USA.Results: A total of 163 randomized clinical trials fulfilled the eligibility criteria. Regrouping them for the same sponsor and IMP resulted in a total of 93 randomized clinical trials. In India, 13 drugs (13.93%) were approved by CDSCO, whereas in USA, 35 drugs (37.62%) were approved by USFDA out of a total of 93 randomized clinical trials. High number of randomized clinical trials were conducted for cancer (17.20%) while less number of randomized clinical trials were conducted for gastrointestinal conditions (3.22%).Conclusions: This study revealed that, there exists a wide gap between the new drug approvals permitted by USFDA and CDSCO. Thus there is disparity in the number of clinical trials conducted and market availability of new drugs in India showing that India is lagging behind the USA in approval of new drugs. The regulatory authorities, investigators and institutional review boards should ensure the availability of new drugs in India after they have been researched in the population.

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“…ctri.nic.in) [1]. The CTRI not only registers trials being conducted in India, but also accepts trials from countries that do not have a primary registry of their own [2][3][4]. The initiative gained a major boost with the implementation of mandatory registration of clinical trials requiring approval by the Indian drug regulatory authority [Drugs Controller General (India), DCGI] [5].…”

Section: Introductionmentioning

confidence: 99%