Clinical Trials

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❘❙❚■ Chapter 33 | Trial Profilea simple trial without any follow-up or exclusions might not require the flow ofparticipants to be described by a trial profile; simple text explanations may suffice.In the survey described above, the percentage of the reports using onlya text description to describe the flow of participants was 5% for The Lancet,86% for the New England Journal of Medicine, 67% for the BMJ, and 14% forJAMA, and the percentage using a text description together with a trial profile was76%, 8%, 22%, and 50%, respectively.Table 1 also shows whether the five suggested components of trial profiles wereincluded in the trial profiles included in the survey. All of those studies thatpublished a trial profile included information on enrollment, randomization,follow-up, and treatment allocation, but very few gave the analysis populationin the trial profile – instead, this was often provided in the text.ConclusionThe use of a trial profile is helpful for reporting the design and results of arandomized clinical trial. Trial profiles diagrammatically and transparentlysummarize a great deal of data that can be interpreted rapidly, holding to theaxiom that a picture is worth a thousand words. We support the CONSORTguidelines and recommend that the template should be used wherever possibleand that, at the very least, the trial profile should include the number of patientsrandomly assigned, receiving treatment, completing the study protocol, andincluded in the final analysis for the primary outcome.References1. Moher D, Schulz KF, Altman DG; for the CONSORT Group. The CONSORT Statement:Revised recommendations for improving the quality of reports of parallel-group randomizedtrials. Available from: www.consort-statement.org. Accessed March 23, 2005.2. Durban Immunotherapy Trial Group. Immunotherapy with Mycobacterium vaccae in patients withnewly diagnosed pulmonary tuberculosis: a randomized controlled trial. Lancet 1999;354:116–9.3. GISSI-Prevenzione Investigators. Dietary supplementation with n-3 polyunsaturated fattyacids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial.Lancet 1999;354:447–55.4. Equi A, Balfour-Lynn IM, Bush A, et al. Long term azithromycin in children with cystic fibrosis:a randomized, placebo-controlled crossover trial. Lancet 2002;360:978–84.384
■■❚❙❘Chapter 34PresentingBaseline DataBelinda Lees, Duolao Wang, and Ameet BakhaiThe presentation of baseline data is essential for the properreporting of a randomized clinical trial. Baseline data describethe characteristics of the population participating in the trial.They are usually recorded at randomization and includepatients’ demographic characteristics, disease-related riskfactors, medical histories, and concurrent medical treatments.In this chapter, we discuss some of the uses of baseline datain clinical trials, data that should be included as baseline datain publications, and issues relating to the significance testingof baseline data.385
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Clinical Trials: A Practical Guide
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■■❚❙❘Chapter 20Comparison
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■■❚❙❘Part IVSpecial Trial
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■■❚❙❘GlossaryGlossary453
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■■❚❙❘IndexIndex467
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