scholarly journals Use of Early Clinical Trial Data to Support Thorough QT Study Waiver for Upadacitinib and Utility of Food Effect to Demonstrate ECG Assay Sensitivity

2017 ◽  
Vol 103 (5) ◽  
pp. 836-842 ◽  
Author(s):  
Mohamed-Eslam F. Mohamed ◽  
Jiewei Zeng ◽  
Ping Jiang ◽  
Balakrishna Hosmane ◽  
Ahmed A. Othman
Keyword(s):  
Clinical Trial ◽  
Food Effect ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Assay Sensitivity ◽  
Early Clinical Trial ◽  
Thorough Qt Study

scholarly journals Early clinical trial data and real‐world assessment of COVID‐19 vaccines: Insights from the Society of Infectious Diseases Pharmacists

2021 ◽  
Vol 41 (10) ◽  
pp. 837-850
Author(s):  
Nimish Patel ◽  
Jeannette Bouchard ◽  
Meredith B. Oliver ◽  
Melissa E. Badowski ◽  
Joseph J. Carreno ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Infectious Diseases ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Early Clinical Trial

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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