Abstract
ObjectiveWe assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.MethodsFor a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data.ResultsRCTs were mostly registered before 13 September 2005 deadline (n = 101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly ‘Key secondary outcomes’ (44.1% RCTs) and ‘Primary outcome’ (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (χ2 1 = 7.255, P = 0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size.ConclusionsICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.
Highlights
The International Committee of Medical Journal Editors (ICMJE) contributed to the development and adopted the first version of 20-item World Health Organization (WHO) Minimum Data Set in 2005, making clear that the journals ‘‘will consider a registration data set inadequate if it has missing fields or fields that contain uninformative terminology’’ [24]
At the time of registration, 152 randomized controlled trial (RCT) had a total of 224 missing registry fields for 9 WHO Minimum Data Set items (Table 1)
Our study demonstrated that the information in the ClinicalTrials.gov registry was often incomplete for the trials whose results were published in the ICMJE member journals during the evaluation period of first 2.5 years after the implementation of their trial registration policy in 2005
Summary
Study publication and outcome reporting biases are two major obstacles to evidence-based practice because they overestimate the effect of experimental treatments, can cause harm and are unethical [1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18]. The transparency of clinical trials has considerably increased with the establishment of public clinical trial registries and legislative changes in many countries [19,20,21,22]. An important momentum for increased transparency in research and reporting in medicine was provided by the International Committee of Medical Journals’ (ICMJE) in 2004, when it put forward its policy on mandatory registration of clinical trials as a precondition for manuscript submission [23]. In February 2006, Item 11 ‘Research Ethics Review’ from the 20-item WHO Minimum Data Set was changed to ‘Countries of recruitment’[25]. In 2007, ICMJE expanded the acceptable primary registers to all those participating in the WHO International Clinical Trials Registry Platform (ICTRP) and implemented the WHO definition of a clinical trial [21]
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