Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Alarcón-Ruiz, Christoper A.; Roque‐Roque, Joel Sack; Heredia, Paula; Gómez-Briceño, Angie; Quispe, Antonio M.

doi:10.1111/jebm.12354

Cited by 4 publications

(6 citation statements)

References 26 publications

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“…During 2011 and 2016, we observed a significant decreasing trend in the REPEC. These results add to a previous report published by our group, 19 which conveyed that this notorious decreasing trend started in the year 2009. The update of the Peruvian regulation could explain this.…”

Section: Cts Registered In the Repecsupporting

confidence: 88%

“…23,31 The percentage of published CTs is a good indicator of monitoring national or regional registries. In the Peruvian context, despite the proportion of publication of the Peruvian conferences' abstracts is lower than 30%, 32,33 Participant countries b (median, IQR) 12 3-20 15 7-24 14 [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] Treatment time, months (median, IQR) 6 1-19 7 (3.2-13) 6 [3][4][5][6][7][8][9][10][11][12][13] Follow-up time, months (median, IQR) 4 1-12 3 1-12 3 [1][2][3][4][5][6][7][8][9][10][11][12] Study duration, months (median, IQR) 36 24-60 34 24-48 36 Year registration in REPEC a (N, %) grants application, and consequently in the manuscript's final draft.…”

Section: Cts Published and Registered In The Repecmentioning

confidence: 99%

“…[14][15][16][17] Previous studies analyzed the REPEC and they reported that over 60% of the registered CTs were completed, 18 and since 2013, the number of registered CTs decreased steadily. 19 Most studies on this topic assessed retrospectively the registry of already published CTs, 20 or the publication of CTs registered only at ClinicalTrials.gov. 4,21 However, the proportion of publication in scientific journals out of all com-…”

Section: Introductionmentioning

confidence: 99%

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Publication and associated factors of clinical trials registered in Peru

Heredia

Alarcón-Ruiz

Roque‐Roque

et al. 2020

J Evidence Based Medicine

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Objective We aim to determine the percentage of publication and its associated factors of clinical trials (CTs) registered in Peru. Methods Using a cross‐sectional study design, we assessed CTs registered at the CT's Peruvian Registry (REPEC) during the 2011‐2016 period, and evaluated its percentage of publication and associated factors. We used a bibliographic search algorithm to determine if the CTs were published and assessed the associated factors by using a Cox regression to estimate the adjusted hazard ratios (aHR) as the magnitude of association of interest. Results We analyzed 228 CTs, of which 63% were published. The regression analysis identified the year of registration (aHR 2012 = 1.15 [0.58‐2.27]; aHR 2013 = 0.45 [0.21‐0.95]; aHR 2014 = 0.89 [0.43‐1.82]; aHR 2015‐2016 = 0.16 [0.05‐0.58]), total number of participants (aHR = 1.12; 1.05‐1.18), and phase III‐IV (aHR = 2.15; 0.1.16‐4.03) as factors associated with the publication of the CTs. Conclusions The percentage of publication of CTs executed in Peru is insufficient, and it increases the older the year of its registration in the REPEC, mayor of the number of participating countries, and if it is a phase III or IV study.

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Section: Cts Registered In the Repecsupporting

confidence: 88%

Section: Cts Published and Registered In The Repecmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Publication and associated factors of clinical trials registered in Peru

Heredia

Alarcón-Ruiz

Roque‐Roque

et al. 2020

J Evidence Based Medicine

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“…Evidence-based practice in old populations relies on clinical trials that were rigorous, transparent, and devoid of bias ( Vidaeff et al., 2016 ; Alarcon-Ruiz et al., 2019 ). Clinical trials provided evidence for clinical practice and were widely regarded as the most crucial evidence source of efficacy and safety ( Ruff et al., 2014 ).…”

Section: Introductionmentioning

confidence: 99%

Registered Interventional Clinical Trials for Old Populations With Infectious Diseases on ClinicalTrials.gov: A Cross-Sectional Study

et al. 2020

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Background Interventional 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 . Methods A cross-sectional study was performed. We used viral OR bacterial OR fungal OR parasitic OR infectious disease to search the 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. Results A total of 138 registered trials were included. Among them, 105(76.1%) trials were completed; however, the results were available in 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. Conclusions The 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.

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“…These include (a) analyses of the quality of registration and missing information in trial records [10][11][12][13], (b) studies on the discrepancies in trial status for trials that are registered in more than one registry [14], and (c) reports on the phenomenon of hidden duplicates [15,16]. Other studies have looked into the evolution of individual registries-the challenges faced, and advances made [17,18]. Such analyses have improved our understanding of clinical trial registries globally, and reinforce the efforts for creating uniform standards for trial registration globally.…”

Section: Introductionmentioning

confidence: 99%

A comparative analysis of important public clinical trial registries, and a proposal for an interim ideal one

Venugopal

Saberwal

2021

PLoS ONE

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Background It is an ethical and scientific obligation to register each clinical trial, and report its results, accurately, comprehensively and on time. The WHO recognizes 17 public registries as Primary Registries, and has also introduced a set of minimal standards in the International Standards for Clinical Trial Registries (ISCTR) that primary registries need to implement. These standards are categorized into nine sections—Content, Quality and Validity, Accessibility, Unambiguous Identification, Technical Capacity, Administration and Governance, the Trial Registration Data Set (TRDS), Partner registries and Data Interchange Standards. This study compared the WHO’s primary registries, and the US’s ClinicalTrials.gov, to examine the implementation of ISCTR, with the aim of defining features of an interim ideal registry. Methods and findings The websites of the 18 registries were evaluated for 14 features that map to one or more of the nine sections of ISCTR, and assigned scores for their variations of these features. The assessed features include the nature of the content; the number and nature of fields to conduct a search; data download formats; the nature of the audit trail; the health condition category; the documentation available on a registry website; etc. The registries received scores for their particular variation of a given feature based on a scoring rationale devised for each individual feature analysed. Overall, the registries received between 27% and 80% of the maximum score of 94. The results from our analysis were used to define a set of features of an interim ideal registry. Conclusions To the best of our knowledge, this is the first study to quantify the widely divergent quality of the primary registries’ compliance with the ISCTR. Even with this limited assessment, it is clear that some of the registries have much work to do, although even a few improvements would significantly improve them.

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Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Cited by 4 publications

References 26 publications

Publication and associated factors of clinical trials registered in Peru

Publication and associated factors of clinical trials registered in Peru

Registered Interventional Clinical Trials for Old Populations With Infectious Diseases on ClinicalTrials.gov: A Cross-Sectional Study

A comparative analysis of important public clinical trial registries, and a proposal for an interim ideal one

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