Identifying and prioritising gaps in colorectal cancer trials research in Australia.

OBJECTIVES: To identify gaps in colorectal cancer clinical trials research in Australia and to suggest and prioritise trials to fill those gaps. DESIGN, SETTING AND PARTICIPANTS: Retrospective review of colorectal cancer trial activity from 1 January 2005 to 1 July 2011 in Australia and internationally, followed by a consensus meeting of consumers, health care professionals, researchers and funding agencies. MAIN OUTCOME MEASURES: Proportion of Phase III and randomised clinical trials in the areas of prevention, screening, surgery, adjuvant therapy, advanced disease and behavioural interventions, and priority areas of research identified by participants at the consensus meeting. RESULTS: The registry search identified 76 colorectal cancer clinical trials (all phases) registered in Australia from 1 January 2005 to 1 July 2011, of which 51 were Phase III or randomised, and 323 Phase III and randomised trials registered worldwide. In Australia, most trials were in advanced colorectal cancer (32), screening (10), and behavioural interventions (9). Worldwide, most Phase III or randomised trials were in advanced disease (94, 29.1%), surgery (64, 19.8%), behavioural interventions (38, 11.8%), and screening (30, 9.3%). At the consensus meeting, all participant groups emphasised the need for research in secondary prevention, screening, individualised treatments and follow-up care after treatment for colorectal cancer. CONCLUSIONS: There is a mismatch between the high proportion of registered trials in advanced colorectal cancer and the areas of priority identified. The development of specific trials in these priority areas depends on the availability of funding and the existence of plausible interventions likely to improve patient outcomes.