Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I.; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

doi:10.1016/j.ajodo.2014.07.019

Cited by 14 publications

(10 citation statements)

References 32 publications

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“…The results emphasized that industry sponsors differ from non-industry sponsors with respect to the characteristics of clinical trials such as number of locations [9,10,21], participants [8,11,13], trial duration, type of trial [37,38], device type, disease category [11,14] and country of sponsor [13] which is in agreement with the literature as well.…”

Section: A Industry Vs Non-industry Sponsors: Locations Participansupporting

confidence: 84%

Sponsorship and characteristics of medical device clinical trials registered in Indian Trial Registry

Rekha

2017

2017 IEEE Technology &Amp; Engineering Management Conference (TEMSCON)

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The present day world has been experiencing rapid technological advancement on the one hand and an ever increasing number of diseases afflicting the human beings on the other. To deal with the later, medical devices are innovated and introduced in to the market (making use of the technological advancements), on a continuous basis across the world. However, introducing an innovated medical device to the market poses innumerable challenges and therefore, these have to be clinically trialed before its market launch to ensure safety and efficacy. India has emerged as one of the attractive and preferred countries by sponsors to execute clinical trials because of its various advantages. Sponsors play a crucial role for the successful conduction of clinical trials. Given the fact that Indian medical devices industry is growing at a faster pace, this paper attempts to understand and highlight the characteristics of medical devices that are registered in Indian trial registry. The present study has been carried out based on secondary data covering 108 medical device clinical trial registrations accessed from Clinical Trial Registry of India (CTRI) database pertaining to the period 2008-2014. These 108 medical device trials are analyzed based on the type of sponsorship.

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Section: A Industry Vs Non-industry Sponsors: Locations Participansupporting

confidence: 84%

Sponsorship and characteristics of medical device clinical trials registered in Indian Trial Registry

Rekha

2017

2017 IEEE Technology &Amp; Engineering Management Conference (TEMSCON)

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“…Although several studies have estimated the proportion of incomplete or selective reporting in various medical specialties [ 14 – 17 ], no such assessments exist in orthodontics. A previous study [ 18 ] provided an overview of registered trials in orthodontics up to 2014, but was limited to descriptive analysis of their registrations and did not assess which were eventually published. Aim of the present study was to assess the publication fate of registered orthodontic randomized clinical trials and to assess characteristics related to their publication timing.…”

Section: Introductionmentioning

confidence: 99%

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all

et al. 2017

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A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

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“…Moreover, within the registration form of a trial, the authors report some information that is sometimes not very clear in the manuscript (e.g., primary outcome, characteristics of subjects, funding). In fact, other reviews have analyzed registered clinical trials, for instance for investigating the characteristics of general registered trials [64], including sponsorship [65], or of specific topics such as ophthalmology [66], orthodontics [67], infection diseases [68], drug trials [69]. However, our review also has some limitations.…”

Section: Discussionmentioning

confidence: 99%

A Review of Registered Clinical Trials on Dietary (Poly)Phenols: Past Efforts and Possible Future Directions

Marino

Bò

Martini

et al. 2020

Foods

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In recent years, the increasing number of studies on polyphenol demonstrates the efforts in elucidating the potential role of these bioactives on human health. This study reviews the main topics and characteristics of clinical trials on polyphenols registered over the last 20 years, in order to track past and current efforts as well as to highlight the main research gaps in this field. The review was conducted by collecting trials registered in ClinicalTrials.gov and International Standard Randomised Controlled Trial Number (ISRCTN) registry. Overall, 750 clinical trials were selected and included in the final evaluation. Most of the trials were performed on extracts or pure compounds followed by studies conducted on polyphenol-rich foods, in particular berries. A total of 520 clinical trials focused on health effects, 55 on bioavailability, and 175 on both. Regarding outcomes, 139 registered intervention studies had the lipid profile and blood pressure as primary outcomes. The overview provided by this analysis also emphasizes the emerging interest in new outcomes related to polyphenols intervention such as microbiota composition and the evaluation of inter-individual variability in response to the intake of polyphenols. Our review underlines the need of further trials covering unexplored or debated research aspects and provides insights for the design and development of future intervention studies and related research areas.

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Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry

Cited by 14 publications

References 32 publications

Sponsorship and characteristics of medical device clinical trials registered in Indian Trial Registry

Sponsorship and characteristics of medical device clinical trials registered in Indian Trial Registry

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all

A Review of Registered Clinical Trials on Dietary (Poly)Phenols: Past Efforts and Possible Future Directions

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