Korjonen, M.H.; (2012) Clinical trial information: developing an effective model of dissemination and a framework to improve transparency. Doctoral thesis , UCL (University College London).

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Abstract

Purpose: The research aim has two parts: Firstly, to characterise and evaluate clinical trial information and the dissemination of that information by constructing a conceptual model structuring the processes of information generation. Secondly, to test the model by identifying the dissemination methods used, consider their effectiveness and what factors affect dissemination. The research findings contribute to outline a framework of recommendations with an optimal model of effective dissemination for improved transparency in clinical research. Design and methodology: Based on the literature review, a conceptual model was constructed outlining the structure of information generation throughout the clinical research process. A mixed approach with qualitative and quantitative studies were undertaken to form a comprehensive picture of the dissemination of clinical trial information and in order to test the model. Key findings: The model identified that clinical trial information is very complex, scattered across many resources and many factors affect how, where and what clinical trial information is disseminated. A model of effective dissemination and a framework of recommendations for improved transparency in dissemination were drawn up for three areas; regulations and standards, communication planning and the organisation of clinical trial information. Limitations: This research has been done during a time of significant and rapid change in the clinical research environment and therefore this thesis is a snapshot of a time when new web tools allows for information to be disseminated rapidly. A series of small studies were made to gather an overall picture of information transparency in clinical trials as we lack evidence in these new areas. Originality/value: There is no existing conceptual model that explains and tests the dissemination and transparency of clinical trial information. Models can structure processes, suggest improvements in the processes and be used as a basis for further research.

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