Information Needs in a Clinical Trials Unit

Abstract

The aim of the study was to analyse the information needs of the Clinical Trials Unit (CTU) at Velindre Hospital, a specialist cancer centre, and the Wales Cancer Trials Network (WCTN). The purpose was to determine the trial information needs that may be collected via the Velindre hospital information system, and the data structure required to store that information. A case study approach was adopted with semi-structured interviews (17 face-to-face interviews with staff based at Velindre Hospital and three telephone interviews with staff at other trial centres in Wales) complemented by document analysis, and an analysis of trial activity databases either in use or under development. A core information set, common to all trials, was identified and this can be collected in ISCO. The document-based trial-specific information is best made available in HTML format. Entity-relationship model diagrams were developed to show the data structure. The study concluded that trial activity information needs can be satisfied as a byproduct of collecting patient trial information in a hospital information system. Patient care should be improved by the greater availability of trials information, and accrual may be increased through identification of potential trial candidates.