ABSTRACT
The reporting of the results from a clinical trial is one of the most anxiously awaited aspects of the clinical trials process. This reporting can take on many forms: reports to investigators during the conduct of the trial; interim outcome reports to the Data Monitoring Committee; abstracts submitted to scientific meetings; and finally, the published report in the medical literature. For any type of study report, it is important to recognize what type of information is appropriate to transmit, and how that information can be communicated in the most scientifically appropriate fashion. In 2001 an international committee comprised of clinical trialists, statisticians, epidemiologists, and editors of biomedical journals reviewed the quality of reporting for randomized clinical trials. The result of this review led to two publications under the title of CONSORT (Consolidated Standards for Reporting Trials). The CONSORT statement proposes a flow diagram for reporting trials, and a checklist of necessary items. The checklist and explanatory article have been updated since 2001 (Schulz et al., 2010; Moher et al., 2010) to improve clarity and incorporate recommendations on new topics (see also Simon and Wittes, 1985).
