Authors' objectives:

The aim of this report was to undertake a systematic review of the relevant literature relating to the barriers, modifiers and benefits involved in participating in randomised controlled trials of cancer therapies as perceived by health professionals and patients.

Authors' results and conclusions: A total of 12,816 references were identified from literature searches with 56 studies published in 58 papers finally selected for inclusion in the review. The included studies represented both the patients' and the health professionals' perspectives. The health professionals in these studies included doctors, nurses and Clinical Research Associates. Several themes emerged from the research literature. From the patient perspective there were issues of treatment preference and the uncertainty patients feel about participating in trials. The role of knowledge and information was examined as was the need to time the request for trial participation more carefully. A range of sociodemographic and practical barriers to trial participation were identified alongside issues concerning the benefits of participating in trials. From the health professional perspective a range of system-related and organisational barriers were identified, barriers inherent in a trial's design and barriers connected with the attitudes of individual health professionals. Although a range of barriers to trial participation were identified, a number of threats to the internal and external validity of the included studies limited interpretation of the evidence. In particular it was found that the issues identified in many of the studies could be, at least partially, an artefact of the research design, the methods of data collection or data analysis.

Authors' recommendations: The methodological limitations of the primary studies identified by this review do not allow a clear interpretation of the barriers, moderators and benefits involved in trial participation as perceived by patients and health professionals. It is necessary to be cautious in stating what is and is not a barrier to trial participation. Instead it is concluded that the particular interplay of barriers, modifiers and benefits relevant to participation in cancer trials needs to be prospectively identified by trialists in the light of the themes identified in the literature. Checklists to guide this process are included in this report.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.york.ac.uk/inst/crd/CRD_Reports/crdreport31.pdf

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: University of York

Contact Address: University of York, York, Y01 5DD, United Kingdom. Tel: +44 1904 321040, Fax: +44 1904 321041,

Contact Name: crd@york.ac.uk

Contact Email: crd@york.ac.uk

Copyright: Centre for Reviews and Dissemination