Professional Development

40 - CONSORT statement II
CONSORT comprises a checklist of 21 items and a flow diagram to help improve the quality of reports on randomized controlled trials. It offers a standard trial reporting format to researchers. The checklist includes evidence-based items that must be addressed in the report; the flow diagram provides readers with a clear picture of the progress of all participants in the trial, from the time they are randomized until the end of their involvement. The intent is to make the experimental process more clear, flawed or not, so that users of the data can more appropriately evaluate its validity for their purposes.As an example of ethical issues in clinical trials, we must not forget that adverse events found during a clinical trial must be first communicated to the Local Health Authorities prior to publication of data.