Clinical Trials

❘❙❚■ Chapter 33 | Trial ProfileWhat is a trial profile?A trial profile diagrammatically summarizes the flow of participants througheach stage of a randomized controlled trial. A flow chart is recommended todisplay this information clearly. The CONSORT (Consolidated Standards ofReporting Trials) guidelines for reporting parallel-group randomized controlledtrials state that researchers should use a trial profile “specifically for each studypopulation and report the numbers of participants randomly assigned, receivingintended treatment, completing the study protocol, and analyzed for the primaryoutcome.” Deviations from the planned study protocol should also be described,and reasons given [1].What should be included in a trial profile?Figure 1 shows the template recommended by CONSORT for the reporting of theflow of participants through each stage of a randomized trial. Essentially, a trialprofile consists of five components:1. Enrollment. Ideally, this should include the number of patients screened forinclusion into the trial; this will allow the reader to determine whether theparticipants are representative of all patients seen with the disease.2. Randomization. The number of participants fulfilling the inclusion andexclusion criteria, and the number randomly allocated to a treatment armshould be given. This allows the overall size of the trial to be determined andenables the reader to see whether the study uses an intention-to-treat analysis.3. Treatment allocation. This is the number of participants allocated to eachgroup who actually receive the treatment. The reasons for not receivingtreatment after randomization as allocated should be given, such as withdrawalof consent by the subject.4. Follow-up. This is the number of participants who completed follow-up asallocated by treatment arm. Reasons for not completing follow-up or treatmentshould be given.5. Analysis. The number of participants included in the analysis should be givenby study group, with reasons for excluding patients.Since a trial profile gives only a brief summary of the flow of participants, a textdescription is sometimes also given in a report to provide further information on378