Abstract
BackgroundWhen the publication of important trial data is delayed, or data are never published, this will prevent the proper practice of evidence based medicine through robust systematic reviews. Clinical trial registries allow researchers to interrogate the trial protocol and afford the opportunity to identify studies that have been completed and so determine the time lag between completion and publication. MethodsWe searched ClinicalTrials.gov with the keywords ‘cystic fibrosis’. Intervention trials which had completed 1st Jan 1998–31st Dec 2010 were selected. Time to publication in a peer-reviewed journal was calculated. Survival analyses using the log rank test were undertaken. ResultsWe identified 142 records. Of these, 62 had full paper publications. The median time to publication was 3.25years. Phase of study (phase one studies more delayed, p=0.024) but not source of funding (p=0.34) was associated with time to publication. ConclusionsClinical trials in cystic fibrosis take a considerable amount of time to report their findings. More importantly, a large number of trials fail to report at all.
Highlights
Evidence based medicine depends upon access to the results of well designed trials which have minimal bias [2]
We present an evaluation of time taken to report clinical trials which involved patients with cystic fibrosis (CF)
We conducted a survival analysis for the whole cohort of studies, and several subgroup analyses using the log rank test to determine if the categorical variables funding source, phase of study, number of countries, age of participants and number of sites were associated with the likelihood of publication
Summary
Evidence based medicine depends upon access to the results of well designed trials which have minimal bias [2]. In 2005 the International Committee of Medical Journal Editors announced that trial publication in participating journals would be dependent upon registration of a summary protocol of the trial with a public registry [3]. This allows an assessment to be made of the total number of clinical trials in any particular field, and allows comparison of the trial report with a protocol summary. Studies with positive results are published more quickly than other studies [6] It is the most common inherited life limiting disease in the Caucasian population, cystic fibrosis (CF) is a rare disease. We present an evaluation of time taken to report clinical trials which involved patients with CF
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