Contemporary clinical trials
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Contemp Clin Trials · Feb 2006
ReviewThe use of unequal randomisation ratios in clinical trials: a review.
To examine reasons given for the use of unequal randomisation in randomised controlled trials (RCTs). ⋯ Although unequal randomisation offers a number of advantages to trials the method is rarely used and is especially under-utilised to reduce trial costs. Unequal randomisation should be considered more in trial design especially where there are large differences between treatment costs.
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Contemp Clin Trials · Oct 2005
Recruitment index as a measure of patient recruitment activity in clinical trials.
Recruitment of patients for clinical trials is one of the major hurdles on the way to successful completion of any human research study. Direct comparison of recruitment activity in different sites and projects is not easy due to lack of a unified measure of recruitment efficacy. The author introduces a new variable, the Recruitment Index, which represents the number of days required for an average study site in a multicenter study to recruit one analyzable patient. Once established in previous studies, an indication-specific Recruitment Index can be used for a variety of purposes, e.g. evaluation of efficacy of various recruitment strategies, planning duration of recruitment period for a new study, or projecting the number of participating sites required to supply a given number of analyzable patients within a certain period.
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Contemp Clin Trials · Aug 2005
The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement.
If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. ⋯ RCTs reported: sequence generation 80% (95% CI 75-80%), allocation concealment 48% (95% CI 42-54%), randomization implementation 55% (95% CI 49-61%), blinding status of participants 40% (34-46%), health care providers 17% (95% CI 13-22%), outcome assessors 47% (95% CI 41-53%), data analysts 15% (10-19%), sample size justification 83% (95% CI 78-87%), method of analysis 87% (95% CI 83-91%)), and participant flow diagrams 86% (95% CI 82-90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations.