Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Figure 1. The CONSORT flow chart. Template for reporting the flow of participants through each stageof a randomized controlled trial [1].EnrollmentAssessed for eligibility(n = ...)Randomized(n = ...)Excluded (n = ...)Not meeting inclusion criteria(n = ...)Refused to participate(n = ...)Other reasons (n = ...)AllocationAllocated to intervention(n = ...)Received allocated intervention(n = ...)Did not receive allocatedintervention (n = ...)(give reasons)Allocated to intervention(n = ...)Received allocated intervention(n = ...)Did not receive allocatedintervention (n = ...)(give reasons)Follow-upLost to follow-up (n = ...)(give reasons)Discontinued intervention(n = ...) (give reasons)Lost to follow-up (n = ...)(give reasons)Discontinued intervention(n = ...) (give reasons)AnalysisAnalyzed (n = ...)Excluded from analysis(n = ...) (give reasons)Analyzed (n = ...)Excluded from analysis(n = ...) (give reasons)the conduct of the trial. For instance, the date the trial started and stopped,and the duration of follow-up are often described in the text. Also, since thenumbers of participants included in the efficacy and safety analyses are oftendifferent, the report should give descriptions of the efficacy and safety populations.What is the purpose of a trial profile?A trial profile is a clear way of showing whether or not the participants receivedthe treatment as allocated (and if not, why not), and also whether they were lostto follow-up or excluded from the analysis. This is important because patients who379