Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

Viergever, Roderik F.; Li, Keyang

doi:10.1136/bmjopen-2015-008932

Cited by 182 publications

(174 citation statements)

References 65 publications

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“…Although ClinicalTrials.gov continues to be the most useful data source, we found that duplication with other registries is increasing; a finding confirmed by a recent study on trends in global clinical trial registration on the national and regional registries searchable via the WHO's ICTRP 19 . Posting of summary results is now mandatory for interventional trials registered with the EU Clinical Trials Database (EudraCT) and completed on or after 21 July 2014 20 , and required retrospectively for trials completed before that date in accordance with specific timeframes 21 .…”

Section: Clinical Trial Transparency Of Recently Approved Medicinessupporting

confidence: 76%

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013

Deane

Sivarajah

2017

Current Medical Research and Opinion

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Background: The objective of this study was to assess the timely disclosure of results of companysponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2013. This is an extension of two previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012. The original study found that over a three year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The extension study (2012 approvals) showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% by the end of the study. Methods: The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2013, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2015. Outcome measures and results: The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2015 (end of survey). Of the completed trials associated with 34 new medicines licensed to 24 different companies in 2013, results of 90% (484/539) had been disclosed within 12 months, and results of 93% (500/539) had been disclosed by 31 July 2015. Conclusions: The disclosure rate within 12 months of 90% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 93% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2013.

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Section: Clinical Trial Transparency Of Recently Approved Medicinessupporting

confidence: 76%

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013

Deane

Sivarajah

2017

Current Medical Research and Opinion

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“…4 Thousands of clinical trials used to be conducted annually but the share Asia about 10% this number usually goes to East Asia, where the share of KSA is less than 0.5%. 5 In the past, conducting of these trials in the KSA usually as a relationship between pharmaceutical companies and the clinical researchers without rules and regulation until the SFDA intervene and give permission to create contract research organization (CRO) to work as a moderator between the clinical researchers and pharmaceutical companies in parallel with GCP guidelines. This is the case in Japan and South Korea where both countries started recently practicing clinical trials according to GCP standards.…”

Section: Introductionmentioning

confidence: 99%

Obstacles in conducting clinical trials in the Saudi Arabia

Suwaidan¹,

Alsuwaidan

2017

Int J Clin Trials

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Background: Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern. It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.Methods: Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.Conclusions: To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.

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“…Furthermore, even in the re-gions where clinical trials are regulated and compulsory, laws tend to exclude all trial types, e.g., phase 1 trials and device trials. This can lead to a limitation in the number of phase 1 trials that are registered [35] .…”

Section: Discussionmentioning

confidence: 99%

Open-Angle Glaucoma: Drug Development Pipeline during the Last 20 Years (1995-2015)

et al. 2017

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Objectives: To analyse drug development for open-angle glaucoma during the last 20 years. Methods: Research was performed by referring to clinical trials registered at the International Clinical Trials Registry Platform (ICTRP). A search for the condition “open-angle glaucoma” with the intervention “drug” was performed. We included trials registered from 01/01/1995 to 01/01/2015, only involving studies in phases 1, 2, and 3. Only studies resorting to novel treatment strategies (either novel drugs or yet-untested fixed associations of approved medication) were considered. Results: We recorded 158 studies for the condition of open-angle glaucoma with a drug-based intervention; 65 of the studies reported phase 2 trials and 74 reported phase 3 trials. Pharmaceutical companies were the primary sponsors of 95.3% of the trials. Most of the studies (66.5%, n = 105) involved a new drug, and the remainder (33.5%, n = 53) tested fixed drug associations. The bulk of the trials (n = 99, 62.7%) involved the use of prostaglandin analogues, either as a comparator or a study drug. In descending order of frequency, the studies conducted involved Rho-kinase inhibitors (n = 15), carbonic anhydrase inhibitors (n = 14), β-blockers (n = 7), angiostatic steroids (n = 6), α₂-adrenergic agonists (n = 4), 5-HT_2A receptor agonists (n = 4), and NMDA receptor antagonists (n = 2). A cyclin-dependent kinase inhibitor, an LIM-domain kinase 2 inhibitor, an A1 adenosine receptor agonist, catechin, macrolide, saffron, and seawater were each tested in 1 clinical trial. Conclusion: Research into the medical treatment of glaucoma indicates the use of prostaglandin analogues. However, there are a significant number of trials testing other drug classes, particularly Rho-kinase inhibitors. This new focus could lead to a potential increase in the number of therapeutical options for the management of glaucoma in the future.

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Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

Cited by 182 publications

References 65 publications

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013

Obstacles in conducting clinical trials in the Saudi Arabia

Open-Angle Glaucoma: Drug Development Pipeline during the Last 20 Years (1995-2015)

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