Introduction In order to further advance research and development on the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard, the existing research must be well understood. This paper presents a methodological review of the ODM literature. Specifically, it develops a classification schema to categorize the ODM literature according to how the standard has been applied within the clinical research data lifecycle. This paper suggests areas for future research and development that address ODM’s limitations and capitalize on its strengths to support new trends in clinical research informatics. Methods A systematic scan of the following databases was performed: (1) ABI/Inform, (2) ACM Digital, (3) AIS eLibrary, (4) Europe Central PubMed, (5) Google Scholar, (5) IEEE Xplore, (7) PubMed, and (8) ScienceDirect. A Web of Science citation analysis was also performed. The search term used on all databases was “CDISC ODM.” The two primary inclusion criteria were: (1) the research must examine the use of ODM as an information system solution component, or (2) the research must critically evaluate ODM against a stated solution usage scenario. Out of 2,686 articles identified, 266 were included in a title level review, resulting in 183 articles. An abstract review followed, resulting in 121 remaining articles; and after a full text scan 69 articles met the inclusion criteria. Results As the demand for interoperability has increased, ODM has shown remarkable flexibility and has been extended to cover a broad range of data and metadata requirements that reach well beyond ODM’s original use cases. This flexibility has yielded research literature that covers a diverse array of topic areas. A classification schema reflecting the use of ODM within the clinical research data lifecycle was created to provide a categorized and consolidated view of the ODM literature. The elements of the framework include: (1) EDC (Electronic Data Capture) and EHR (Electronic Health Record) infrastructure; (2) planning; (3) data collection; (4) data tabulations and analysis; and (5) study archival. The analysis reviews the strengths and limitations of ODM as a solution component within each section of the classification schema. This paper also identifies opportunities for future ODM research and development, including improved mechanisms for semantic alignment with external terminologies, better representation of the CDISC standards used end-to-end across the clinical research data lifecycle, improved support for real-time data exchange, the use of EHRs for research, and the inclusion of a complete study design. Conclusions ODM is being used in ways not originally anticipated, and covers a diverse array of use cases across the clinical research data lifecycle. ODM has been used as much as a study metadata standard as it has for data exchange. A significant portion of the literature addresses integrating EHR and clinical research data. The simplicity and readability of ODM has likely contributed to its succe...
Background Real-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage RWD and generate reliable RWE, data should be well defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for the development of clinical medicine and therapeutics. Clinical Data Interchange Standards Consortium (CDISC) data standards are mature, globally recognized, and heavily used by the pharmaceutical industry for regulatory submissions. The CDISC RWD Connect Initiative aims to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement them. Objective The aim of this study is to understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance that may be needed to implement CDISC standards more easily for this purpose. Methods We conducted a qualitative Delphi survey involving an expert advisory board with multiple key stakeholders, with 3 rounds of input and review. Results Overall, 66 experts participated in round 1, 56 in round 2, and 49 in round 3 of the Delphi survey. Their inputs were collected and analyzed, culminating in group statements. It was widely agreed that the standardization of RWD is highly necessary, and the primary focus should be on its ability to improve data sharing and the quality of RWE. The priorities for RWD standardization included electronic health records, such as data shared using Health Level 7 Fast Health care Interoperability Resources (FHIR), and the data stemming from observational studies. With different standardization efforts already underway in these areas, a gap analysis should be performed to identify the areas where synergies and efficiencies are possible and then collaborate with stakeholders to create or extend existing mappings between CDISC and other standards, controlled terminologies, and models to represent data originating across different sources. Conclusions There are many ongoing data standardization efforts around human health data–related activities, each with different definitions, levels of granularity, and purpose. Among these, CDISC has been successful in standardizing clinical trial-based data for regulation worldwide. However, the complexity of the CDISC standards and the fact that they were developed for different purposes, combined with the lack of awareness and incentives to use a new standard and insufficient training and implementation support, are significant barriers to setting up the use of CDISC standards for RWD. The collection and dissemination of use cases, development of tools and support systems for the RWD community, and collaboration with other standards development organizations are potential steps forward. Using CDISC will help link clinical trial data and RWD and promote innovation in health data science.
DDI and Enhanced Data Citation
BACKGROUND Real World Data (RWD) and Real World Evidence (RWE) have an increasingly important role in clinical research and health care decision making in many countries. In order to leverage RWD and generate reliable RWE, a framework must be in place to ensure that the data is well-defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for clinical medicine and therapeutics development. CDISC data standards are mature, globally recognized and heavily utilized by the pharmaceutical industry for regulatory submission in the US and Japan and are recommended in Europe and China. Against this backdrop, the CDISC RWD Connect Initiative was initiated to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement CDISC standards for this purpose. We believe that bridging the gap between RWD and clinical trial generated data will benefit all stakeholders. OBJECTIVE The aim of this project was to understand the barriers to implementing CDISC standards for Real World Data (RWD) and to identify what tools and guidance may be needed to more easily implement CDISC standards for this purpose. METHODS We conducted a qualitative Delphi survey involving an Expert Advisory Board (EAB) with multiple key stakeholders, with three rounds of input and review. RESULTS In total, 66 experts participated in round 1, 56 participated in round 2 and 49 participated in round 3 of the Delphi Survey. Their input was collected and analyzed culminating in group statements. It was widely agreed that the standardization of RWD is highly necessary, and the primary focus should be on its ability to improve data-sharing and the quality of RWE. The priorities for RWD standardization include electronic health records, such as data shared using HL7 FHIR, and data stemming from observational studies. With different standardization efforts already underway in these areas, a gap analysis should be performed to identify areas where synergies and efficiencies are possible and then collaborate with stakeholders to create, or extend existing, mappings between CDISC and other standards, controlled terminologies and models to represent data originating across different sources. CONCLUSIONS There are many ongoing data standardization efforts that span the spectrum of human health data related activities including, but not limited to, those related to healthcare, public health, product or disease registries and clinical research, each with different definitions, levels of granularity and purpose. Amongst these standardization efforts, CDISC has been successful in standardizing clinical trial-based data for regulation worldwide. However, the complexity of the CDISC standards, and the fact that they were developed for different purposes, combined with the lack of awareness and incentives to using a new standard, insufficient training and implementation support are significant barriers for setting up the use of CDISC standards for RWD. The collection and dissemination of use cases showing in detail how to effectively implement CDISC standards for RWD, developing tools and support systems specifically for the RWD community, and collaboration with other standards development organizations and initiatives are potential steps towards connecting RWD to research. The integrity of RWE is dependent on the quality of the RWD and the data standards utilized in its collection, integration, processing, exchange and reporting. Using CDISC as part of the database schema will help to link clinical trial data and RWD and promote innovation in health data science. The authors believe that CDISC standards, if adapted carefully and presented appropriately to the RWD community, can provide “FAIR” structure and semantics for common clinical concepts and domains and help to bridge the gap between RWD and clinical trial generated data. CLINICALTRIAL Not Applicable
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.