Important issues in planning and conducting multi-centre randomised trialsin cancer and publishing their results

The principles and practical issues involved in planning and conducting mul ti-centre randomised trials in cancer and in publishing their results are r eviewed for the benefit of those conducting trials or planning to do so. Th ere is increasing public awareness of the importance of randomised trials a nd this needs to be nurtured. Questions addressed by trials must be clinica lly worthwhile, and trials must be planned and conducted to provide reliabl e results that will convince the clinical community and influence future cl inical practice to patients' benefit. Trial protocols must justify the tria l and give clear and unambiguous instructions to collaborating centres. Onl y data necessary for answering the trial questions should be collected, and the reliability of data should be checked. All trials should be published in peer-reviewed journals, and ways should be considered of communicating t heir results to patients, their families and the public. Wide consultation and independent review are needed to achieve these aims. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.