abstract
- BACKGROUND: Clinical trials are the principal means by which new treatment approaches are evaluated in medicine. It has been argued that randomised clinical trials provide the highest standard of care and at the same time help to contribute to scientific knowledge. However, only a relatively small proportion of cancer patients receive treatment as part of a formal clinical trial. This article provides a broad review of the issues pertinent to physician and patient participation in randomised clinical trials. METHODS: Search of computerised electronic databases (Medline, Psychlit, Cinhail, Embase). RESULTS: There are a variety of physician and patient characteristics which have previously been shown to influence participation in randomised clinical trials. Additionally, ethical concerns about randomised trials in general and the additional requirements of informed consent for clinical trials, may impact on recruitment. Whilst there is some research examining strategies to improve patient understanding about clinical trials and promote patient involvement in clinical decision-making, there are deficiencies in these areas. In particular there is a paucity of research examining the association between knowledge about clinical trials, anxiety associated with a new cancer diagnosis and willingness to participate in randomised clinical trials. CONCLUSIONS: Further research also is needed to evaluate strategies to better inform patients about clinical trials.