Clinical Research Informatics: Recent Advances and Future Directions

Dugas, Martin

doi:10.15265/iy-2015-010

“…Randomized clinical trials are the gold standard for evaluating healthcare interventions and, more generally, add to the medical knowledge related to the treatment, diagnosis and prevention of diseases and conditions [ [1] , [2] , [3] , [4] , [5] , [6] ]. Recent literature continues to identify health informatics methods that can help improve study efficiency throughout the life cycle of a clinical trial [ [7] , [8] , [9] , [10] ]. Electronic medical record (EMR) data provides a mechanism to facilitate clinical trials during the study planning and execution phases, and ultimately, can be utilized to enhance recruitment [ 5 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

An initiative using informatics to facilitate clinical research planning and recruitment in the VA health care system

Velarde

¹

,

Romesser

²

,

Johnson

³

et al. 2018

Contemporary Clinical Trials Communications

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BackgroundRandomized clinical trials are the gold standard for evaluating healthcare interventions and, more generally, add to the medical knowledge related to the treatment, diagnosis and prevention of diseases and conditions. Recent literature continues to identify health informatics methods that can help improve study efficiency throughout the life cycle of a clinical trial. Electronic medical record (EMR) data provides a mechanism to facilitate clinical trial research during the study planning and execution phases, and ultimately, can be utilized to enhance recruitment. The Department of Veterans Affairs (VA) has a strong history of clinical and epidemiological research with over four decades of data collected from Veterans it has served nationwide. The VA Informatics and Computing Infrastructure (VINCI) provides VA research investigators with a nationwide view of high-value VA patient data. Within VA, the Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine sites that are part of an embedded clinical research infrastructure intended to provide systematic site-level solutions to issues that arise during the conduct of VA CSP clinical research. This paper describes the collaboration initiated by the Salt Lake City (SLC) node site to bring informatics and clinical trials together to enhance study planning and recruitment within the VA.MethodsThe SLC VA Medical Center physically houses both VINCI and a node site and the co-location of these two groups prompted a natural collaboration on both a local and national level. One of the functions of the SLC NODES is to enhance recruitment and promote the success of CSP projects. VINCI supports these efforts by providing VA researchers access to potential population pools. VINCI can provide 1) feasibility data during study planning, and 2) active patient lists during recruitment. The process for CSP study teams to utilize these services involves regulatory documentation, development of queries, revisions to the initial data request, and ongoing communications with several key study personnel including the requesting research team, study statisticians, and VINCI data managers.ResultsThe early efforts of SLC NODES and VINCI aimed to provide patient lists exclusively to the SLC CSP study teams for the following purposes: 1) increasing recruitment for trials that were struggling to meet their respective enrollment goals, and 2) decreasing the time required by study coordinators to complete chart review activities. This effort was expanded to include multiple CSP sites and studies. To date, SLC NODES has facilitated the delivery of these VINCI services to nine active CSP studies.ConclusionThe ability of clinical trial study teams to successfully plan and execute their respective trials is contingent upon their proficiency in obtaining data that will help them efficiently and effectively recruit and enroll eligible participants. This collaboration demonstrates that the utilization of a model that partners two distinct entitie...

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“…This review seeks to summarize significant developments in the field of clinical research informatics (CRI) for the years 2015-2016. The approach continues the tradition of past reviews of the IMIA Yearbook by focusing on a relatively small number of publications that are representative of current work in clinical research informatics [1][2][3][4].…”

Section: Introductionmentioning

confidence: 99%

Clinical Research Informatics: Supporting the Research Study Lifecycle

Johnson¹

2017

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SummaryObjectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years [2015][2016]. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions.

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“…The approach continues the tradition of past reviews of the IMIA Yearbook by focusing on a relatively small number of publications that are representative of current work in clinical research informatics [1][2][3][4].…”

Section: Introductionmentioning

confidence: 99%

Clinical Research Informatics: Supporting the Research Study Lifecycle

Johnson¹

2017

Yearb Med Inform

0

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SummaryObjectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years [2015][2016]. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions.

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Clinical Research Informatics: Recent Advances and Future Directions

Cited by 7 publications

References 34 publications

An initiative using informatics to facilitate clinical research planning and recruitment in the VA health care system

An initiative using informatics to facilitate clinical research planning and recruitment in the VA health care system

Clinical Research Informatics: Supporting the Research Study Lifecycle

Clinical Research Informatics: Supporting the Research Study Lifecycle

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