Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Table 1. Results of a survey on the use of trial profiles in clinical trials published in four general medicaljournals between July and October 1999.The Lancet New BMJ JAMAEngland Journalof MedicineNumber of clinical trials 38 24 18 14Number of trials with a profile 36 (95%) 3 (13%) 5 (28%) 12 (86%)Components Enrollment 36 3 5 12of trial profileRandomization 36 3 5 12Treatment allocation 36 3 5 12Follow-up 35 3 4 12Analysis 11 0 0 1Text description of flow of participants only 2 (5%) 21 (86%) 12 (67%) 2 (14%)Trial profile and text description 29 (76%) 2 (8%) 4 (22%) 7 (50%)of flow of participantsassigned to the treatment they had not already received (crossed over).The primary outcome was median relative difference in forced expiratory volumein 1 second between azithromycin and placebo treatment periods.The trial profile indicates that one patient withdrew and one patient missed theirfinal assessment, but it is not clear in which periods these events occurred.Therefore, the authors explained in the text that one patient in the azithromycin/placebo group withdrew after 4 months of the second treatment period, and onepatient in the placebo/azithromycin group missed the 6-month assessment in thefirst treatment period.Current practice of medical journals on the use of trial profilesTo investigate the practice of medical journals regarding the use of trial profileswhen reporting studies, 94 clinical trial reports were identified that werepublished in four general medical journals during July to October 1999 before therelease of the revised CONSORT statement (38 in The Lancet, 24 in the NewEngland Journal of Medicine, 18 in the BMJ, and 14 in JAMA).In Table 1, a summary of the number of studies giving trial profiles and thenumber giving a text description of flow of participants are provided for thesepublished clinical trials. The use of a trial profile was more frequent in The Lancetand JAMA (95% and 86% respectively) compared with the New England Journalof Medicine (13%) and the BMJ (28%). However, it is important to note that383