Reporting standards and good conduct for randomised trials

Recommendations on the reporting of randomised trials are available from the CONSORT group. These include the main CONSORT statement for reports of randomised trials in general, and also additional statements on reporting of trials in abstracts, cluster trials and adverse effects. These statements, along with bibliographies of articles on specific aspects of the conduct of trials are available on the CONSORT website.

There are several studies and documents that investigate the quality of trials and the quality of their reporting. The Cochrane Methodology Register in The Cochrane Library is a large collection of records for research and guidance into the methods of trials and systematic reviews of trials. This can be searched using a specially prepared set of keywords, which is available in the Help system of The Cochrane Library.

Other sources of information are the International Conference on Harmonization, which has produced guidance relating to good practice in clinical research (ICH E6) and the European Union Directive on the implementation of good clinical practice in the conduct of clinical research on medicinal products in humans. Furthermore, researchers wishing to register their trial will find more information on the World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP).