“…Some studies were excluded because they did not measure links between trial registries and bibliographic databases and, instead, considered links to or from other source of clinical trial information. These included links to or from protocols [34–37], conference or meeting abstracts [38–42], internal company documents [17], Food and Drug Administration (FDA) documents or new drug approvals [43–47], or other databases of published articles [48, 49]. Fig.…”
BackgroundStudies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links.MethodsPubMed and Embase databases were searched from inception to May 2016 for studies linking trial registries with bibliographic databases. The processes used to establish these links were categorised as automatic when the registration identifier was available in the bibliographic database or publication, or manual when linkage required inference or contacting of trial investigators. The number of links identified by each process was extracted where available. Linear regression was used to determine whether the proportions of links available via automatic processes had increased over time.ResultsIn 43 studies that examined cohorts of registry entries, 24 used automatic and manual processes to find articles; 3 only automatic; and 11 only manual (5 did not specify). Twelve studies reported results for both manual and automatic processes and showed that a median of 23% (range from 13 to 42%) included automatic links to articles, while 17% (range from 5 to 42%) of registry entries required manual processes to find articles. There was no evidence that the proportion of registry entries with automatic links had increased (R
2 = 0.02, p = 0.36). In 39 studies that examined cohorts of articles, 21 used automatic and manual processes; 9 only automatic; and 2 only manual (7 did not specify). Sixteen studies reported numbers for automatic and manual processes and indicated that a median of 49% (range from 8 to 97%) of articles had automatic links to registry entries, and 10% (range from 0 to 28%) required manual processes to find registry entries. There was no evidence that the proportion of articles with automatic links to registry entries had increased (R
2 = 0.01, p = 0.73).ConclusionsThe linkage of trial registries to their corresponding publications continues to require extensive manual processes. We did not find that the use of automatic linkage has increased over time. Further investigation is needed to inform approaches that will ensure publications are properly linked to trial registrations, thus enabling efficient monitoring of trial reporting.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-017-0518-3) contains supplementary material, which is available to authorized users.
“…Some studies were excluded because they did not measure links between trial registries and bibliographic databases and, instead, considered links to or from other source of clinical trial information. These included links to or from protocols [34–37], conference or meeting abstracts [38–42], internal company documents [17], Food and Drug Administration (FDA) documents or new drug approvals [43–47], or other databases of published articles [48, 49]. Fig.…”
BackgroundStudies measuring the completeness and consistency of trial registration and reporting rely on linking registries with bibliographic databases. In this systematic review, we quantified the processes used to identify these links.MethodsPubMed and Embase databases were searched from inception to May 2016 for studies linking trial registries with bibliographic databases. The processes used to establish these links were categorised as automatic when the registration identifier was available in the bibliographic database or publication, or manual when linkage required inference or contacting of trial investigators. The number of links identified by each process was extracted where available. Linear regression was used to determine whether the proportions of links available via automatic processes had increased over time.ResultsIn 43 studies that examined cohorts of registry entries, 24 used automatic and manual processes to find articles; 3 only automatic; and 11 only manual (5 did not specify). Twelve studies reported results for both manual and automatic processes and showed that a median of 23% (range from 13 to 42%) included automatic links to articles, while 17% (range from 5 to 42%) of registry entries required manual processes to find articles. There was no evidence that the proportion of registry entries with automatic links had increased (R
2 = 0.02, p = 0.36). In 39 studies that examined cohorts of articles, 21 used automatic and manual processes; 9 only automatic; and 2 only manual (7 did not specify). Sixteen studies reported numbers for automatic and manual processes and indicated that a median of 49% (range from 8 to 97%) of articles had automatic links to registry entries, and 10% (range from 0 to 28%) required manual processes to find registry entries. There was no evidence that the proportion of articles with automatic links to registry entries had increased (R
2 = 0.01, p = 0.73).ConclusionsThe linkage of trial registries to their corresponding publications continues to require extensive manual processes. We did not find that the use of automatic linkage has increased over time. Further investigation is needed to inform approaches that will ensure publications are properly linked to trial registrations, thus enabling efficient monitoring of trial reporting.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-017-0518-3) contains supplementary material, which is available to authorized users.
“…The design of a trial, the manner conducting it and the reporting of the results at the end of the clinical trial should be conducted in a structured manner to maintain the gold standard and the simplicity of evaluating the method of intervention 13,14 . However, clinical trials may yield biased results if they lack methodological rigor.…”
Objective: This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry-India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed. Design and Methods: The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI. Conclusions: Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.
“…Over the years, several researchers have either summarized data hosted by CTRI or posed particular questions of the registered trials. Examples include an analysis of (i) the year-wise distribution of registrations [4]; (ii) the phase-wise distribution of studies [5][6][7]; (iii) the regions of the country in which studies have been carried out [4,5,7,8]; (iv) the conditions for which trials were conducted [4,5,8,9]; (v) the categories of the sponsors [5,[8][9][10][11]; (vi) whether surrogate end points were assessed more frequently in company-sponsored trials [9]; (vii) whether trial methods were better described in CTRI records than in the subsequent publications [12]; and (viii) what fraction of trials were placebo controlled [11]. Researchers have also pointed out various lacunae in the records, such as (i) non-reporting of sample size; (ii) non-reporting of informed consent from minor trial participants; and (iii) inadequate reporting of post-trial obligations [9].…”
Background There has been a significant increase in the number of trials registered with Clinical Trials Registry – India (CTRI) recently. We therefore wished to understand the current landscape of interventional, drug trials that have run in India. Methods We downloaded all trial records on 4 April 2018, and queried the data after it was formatted into an SQLite database. We distinguished trials hosted by India (India-only trials) and those co-hosted by India and other countries (India-etc trials). Results We analyzed eight fields of data, with the following key results: (a) Year of registration: The India-etc set suffered a serious dip in 2013. Both sets increased sharply in 2017. (b) Phase: Phase 3 trials were the most common in both sets of data, but were manifold more common in the India-etc set. 30% of the India-only trials had no phase information. (c) Trial sites: Four states each account for 50% or more of the sites in both sets of data. Also, 7–8 cities accounted for 50% or more sites in both sets. (d) Ethics committees: Over 70% of India-only trials had a single ethics committee, but the India-etc trials had a much greater spread. For each set, the maximum exceeded 60 committees per trial. (e) Principal Investigator (PI): 84% and 73% of PIs in the India-only and India-etc sets, respectively, had run a single trial each. One PI had run as many as 44 trials. (f) Primary sponsors: global pharma companies sponsored less than 5% of the India-only set but 92% of the India-etc set. (g) Fraction of subjects from India in India-etc trials: An abnormally large fraction of participants are not recruited from India. (h) Countries co-hosting the India-etc trials: The pattern was similar to that found for international trials co-hosted by Australia. Conclusions It is important to understand the landscape of trials being run in any country, to understand the recent past, in case of any red flags, and to serve as inputs to changes in policy. The data also serves as a baseline for the future, to ascertain the impacts of new policies, locally or globally.
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