5 Clinical Trial Data Transparency in Canada: Mapping the Progress from Laggard to Leader

Author(s):  
Marc-André Gagnon ◽  
Matthew Herder ◽  
Janice Graham ◽  
Katherine Fierlbeck ◽  
Anna Danyliuk
2014 ◽  
Vol 39 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Demissie Alemayehu ◽  
Richard J. Anziano ◽  
Marcia Levenstein

Therapies ◽  
2007 ◽  
Vol 62 (3) ◽  
pp. 211-216 ◽  
Author(s):  
Nicholas Moore ◽  
Yves Juillet ◽  
Pierre-Henri Bertoye ◽  
Christophe Baduel ◽  
Corinne Bernaud ◽  
...  

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Tabassom Baghai

An ongoing challenge in clinical research is the inaccessibility of clinical trial data, which prevents physicians from making an informed decision with regards to patient care. The U.S. Food and Drug Administration (FDA) as well as the World Health Organization (WHO) recently called for all trial data to be registered and made publically available. However, this issue is still ongoing and there are several measures currently being enforced to rectify these concerns. Potential solutions, such as regulations, campaigns, and possible conse- quences, for increasing transparency in clinical trial data will be discussed. RÉSUMÉ L’inaccessibilité des données provenant d’essais cliniques constitue un défi constant en recherche clinique, puisqu’elle empêche les médecins de prendre des décisions éclairées quant aux soins de leurs patients. Récemment, le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) ainsi que l’Organisation mondiale de la Santé (OMS) ont demandé que toutes les données d’essais cliniques soient enregistrées et mises à la disposition du public. Toutefois, ce problème persiste et plusieurs mesures ont été mises en place pour répondre à ces préoccupations. Des solutions possibles dont des réglementations, des campagnes et des sanctions possibles pour améliorer la transparence en ce qui concerne les données d’essais cliniques seront discutées. 


2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.


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