What is it about?

In recent years, open access and free data exchange has resulted new creative ways of doing science. But, in the area of clinical trials that are experiments involving human participants, the sharing of data and especially the sharing of the individual patient data (IPD), is impeded. Often researchers fear the re-analysis of their data or are concerned the efforts associated with the preparation of data for sharing or the data protection restrictions and as a consequence abstain from sharing their data with other researchers. Indeed, this sharing of data involves a complex set of processes and the interaction of many actors, services and tools. Several clinical trials registries and data repositories excist that collect to some degree data or references to clinical trials. To support the sharing of clinical trials data, several organisations have developed principles, guidance and practical recommendations for implementation (e.g. the Nordic Trial Alliance Working Group on Transparency and Registration for the Nordic countries, the good practice principles for sharing IPD by MRC, UKCRC, CRUK and Wellcome, in the UK). Coordinated by the European Clinical Research Infrastructure Network (ECRIN), a large group of international stakeholders of clinical research has been assembled and principles and recommendations for data sharing of clinical trial data was compiled. But the process of the processing, storage and sharing of clinical trials data is so complex that a common framework does not yet exist; though fragments for an infrastructure can be found. The various services and tools for clinical trials data and documents are rather scattered and a global vision of how all these components are interacting and how they should interact and interoperate does currently not exist. Based on the stakeholder analysis and their recommendations, processes and subprocesses involved in data sharing were identified and linked to actors; possible data services and tools were identified and a framework developed. In our framework the process describes a sequence of activities in an organization with the objective of carrying out work (here data sharing); subprocess is a process that is included within another process; actor is a person or organization taking part in a business activity (here clinical trials data sharing). Our identification of the individual processes and supporting tools is a first step towards the development of a generic framework for the sharing of data from clinical trials, with the aim to make it easier and more transparent.

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Why is it important?

Here, for the first time in our knowledge, the process of sharing of clinical trials data is described is a structured way presenting a common framework that combines processes, actors with different tools / services, like data registries, data repositories, authentication tools, encryption services.

Perspectives

In future data processing and data sharing in research will be increasingly described by automatic data flows. Our framework is a first step in this direction to support automatisation of data processes that include clinical trials data. But because clinical trials data, like other health data, is sensitive data, the development of data pipelines is hampered and our framework is a first step to support developments of automatic data flows for sensitive data.

Wolfgang Kuchinke
Heinrich-Heine-Universitat Dusseldorf

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This page is a summary of: Classification of processes involved in sharing individual participant data from clinical trials, F1000Research, April 2018, Faculty of 1000, Ltd., DOI: 10.12688/f1000research.13789.2.
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