scholarly journals Generalizing from clinical trial data: A case study. The risk of suicidality among pediatric antidepressant users

2008 ◽  
Vol 27 (11) ◽  
pp. 1801-1813 ◽  
Author(s):  
Joel B. Greenhouse ◽  
Eloise E. Kaizar ◽  
Kelly Kelleher ◽  
Howard Seltman ◽  
William Gardner
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data

Do Physicians/Researchers Trade Stock Based on Privileged Information? A Closer Look at Trading Patterns Surrounding the Annual ASCO Conference

2012 ◽  
Vol 40 (2) ◽  
pp. 391-393
Author(s):  
Elie Donath Mark ◽  
J. Eisenberg
Keyword(s):  
Clinical Trial ◽  
Medical Association ◽  
Clinical Oncology ◽  
Clinical Trial Data ◽  
High Impact ◽  
Trial Data ◽  
Privileged Information ◽  
Trading Patterns ◽  
American Society

There is a concern that physicians/researchers are inappropriately profiting (by buying or selling stock) from information derived from advance copies of high-impact clinical trial data distributed by medical conferences or journals. Despite these concerns, it has never been systematically evaluated, and little is known about the degree to which it exists. This is largely due to difficulties associated with directly verifying whether or not such activities have taken place and, furthermore, many medical conferences/journals today have taken the necessary actions to guard against this. One medical association in particular, the American Society of Clinical Oncology (ASCO responsible for conducting the largest annual oncology-related medical conference), only began responding to such concerns several years ago. Their actions during that time serve as a compelling case study, with wide-ranging ramifications, and provide the unique opportunity to delve into this phenomenon.Up until 2008, ASCO selectively and discreetly distributed abstracts from all forthcoming presentations (at the ASCO Conference) to ASCO members two weeks prior to it becoming publicly accessible during the conference.

scholarly journals Parametric Modelling of Migraine Day Frequency In Migraine Prevention: A Case Study Of Erenumab Clinical Trial Data

2017 ◽  
Vol 20 (9) ◽  
pp. A733
Author(s):  
JK Porter ◽  
GL Di Tanna ◽  
G Villa ◽  
A Brennan ◽  
S Palmer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Parametric Modelling ◽  
Migraine Prevention

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

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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