Missing clinical trial data must be made public, federal judge says

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.

The secondary use and linking of health administrative and clinical trial data in cancer: attitudes towards data reuse in Australia

The Breast ◽

10.1016/s0960-9776(21)00249-6 ◽

2021 ◽

Vol 56 ◽

pp. S84

Author(s):

E. Hutchings ◽

B.E. Butcher ◽

P. Butow ◽

F.M. Boyle

Keyword(s):

Clinical Trial ◽

Clinical Trial Data ◽

Trial Data ◽

Data Reuse ◽

Secondary Use

P-75 Impact of an educational activity on the knowledge of oncologists regarding the latest clinical trial data on HER2-directed therapies for gastric and colorectal cancer

Annals of Oncology ◽

10.1016/j.annonc.2021.05.130 ◽

2021 ◽

Vol 32 ◽

pp. S122-S123

Author(s):

N. Dorkhom ◽

D. Cameron ◽

P. Chen ◽

A. Grothey ◽

K. Lucero

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Clinical Trial Data ◽

Trial Data ◽

Educational Activity ◽

P 75

From publication bias to lost in information: why we need a central public portal for clinical trial data

BMJ evidence-based medicine ◽

10.1136/bmjebm-2020-111566 ◽

2020 ◽

pp. bmjebm-2020-111566

Author(s):

Beate Wieseler ◽

Natalie McGauran

Keyword(s):

Clinical Trial ◽

Publication Bias ◽

Clinical Trial Data ◽

Trial Data

Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-020-00246-9 ◽

2021 ◽

Author(s):

Kimie Sai ◽

Eiji Nakatani ◽

Yasuhiro Iwama ◽

Shuichi Hiraoka ◽

Masahiro Tohkin ◽

...

Keyword(s):

Clinical Trial ◽

Retrospective Analysis ◽

East Asian ◽

Clinical Trial Data ◽

Trial Data ◽

Asian Populations

Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data

AIDS and Behavior ◽

10.1007/s10461-019-02742-y ◽

2019 ◽

Vol 24 (6) ◽

pp. 1784-1792 ◽

Cited By ~ 3

Author(s):

Derek D. Satre ◽

Varada Sarovar ◽

Wendy Leyden ◽

Charles B. Hare ◽

Sheryl L. Catz ◽

...

Keyword(s):

Clinical Trial ◽

Antiretroviral Therapy ◽

Alcohol Use ◽

Secondary Analysis ◽

Clinical Trial Data ◽

Trial Data ◽

Unhealthy Alcohol Use ◽

Unhealthy Alcohol ◽

Hiv Rna ◽

Antiretroviral Therapy Adherence