Abstract
Background: In recent years, a cultural change in the handling of research data has resulted in the promotion of a culture of openness and an increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services and tools to support data sharing are becoming available, but what is missing is a detailed, structured and comprehensive list of processes and subprocesses involved and the tools and services needed. Methods: Principles and recommendations from a published consensus document on data sharing were analysed in detail by a small expert group. Processes and subprocesses involved in data sharing were identified and linked to actors and possible supporting services and tools. Definitions adapted from the business process model and notation (BPMN) were applied in the analysis. Results: A detailed and comprehensive tabulation of individual processes and subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools and services to support these processes are identified and grouped according to the major type of support. Conclusions: The identification of the individual processes and subprocesses and supporting tools and services, is a first step towards development of a generic framework or architecture for the sharing of data from clinical trials. Such a framework is needed to provide an overview of how the various actors, research processes and services could interact to form a sustainable system for data sharing.
Highlights
In recent years, many scientific organisations, funders and initiatives have expressed their commitment to more open scientific research
CO has a PhD in mathematics and was head of an academic clinical trial unit with a focus on biostatistics and Information Technology (IT)-support of trials; SC has an MSc in information systems and he is an expert in data management and IT systems for clinical trials, RB is a clinical pharmacologist with an expertise in clinical trial and evidence synthesis methodology; WK has a PhD in molecular genetics with education in clinical pharmacology and he is an expert of information science; SB has a PhD in biological sciences and is the project manager responsible for the Coordinated Research Infrastructures Building Enduring Life-science Services (CORBEL) project for European Clinical Research Infrastructure Network (ECRIN)
Within the framework of the EU H2020 funded project CORBEL major issues associated with sharing of individual participant data (IPD) were investigated and a consensus document on providing access to IPD from clinical trials was developed, using a broad interdisciplinary approach[6]
Summary
Many scientific organisations, funders and initiatives have expressed their commitment to more open scientific research This cultural shift has been extended to include clinical research and clinical trials in particular. Conclusions: The identification of the individual processes and subprocesses and supporting tools and services, is a first step towards development of a generic framework or architecture for the sharing of data from clinical trials. Such a framework is needed to provide an overview of how the various actors, research processes and services could interact to form a sustainable system for data sharing
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
