Article type
Year
Abstract
Background: Clinical trial registration is known to improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base. Through clinical trials registration, it should be possible to take steps to ensure that registered data about health care are informed by all of the available evidence. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-comprehensive.
Objectives: The study is aimed to evaluate the quality of clinical trials registries.
Methods: The quality of 14 primary registries in the World Health Organization (WHO) Registry Network and the ClinicalTrials.gov registry (http://clinicaltrials.gov/) was evaluated by comparing the completeness of WHO 20-item Trial Registration Data Set items.
Results: Among the 15 clinical trials registries included in the study, 40.0% (6/15) of the clinical trials registries ignored the item of ‘date of first enrollment’, 26.7% (4/15) trials registries neglected the item of ‘secondary identifying numbers’, 20.0% (3/15) trials registries unnoticed of ‘Secondary Sponsor(s)’ and ‘Countries of Recruitment’ items. Only four clinical trials registries fulfilled all the 20 items in the WHO Trial Registration Data Set.
Conclusions: Clinical trials registration has the potential to improve clinical trial transparency and reduce publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records. The missing or uninformative entries of key information could be reduced by improving the quality of clinical trial registries.
Objectives: The study is aimed to evaluate the quality of clinical trials registries.
Methods: The quality of 14 primary registries in the World Health Organization (WHO) Registry Network and the ClinicalTrials.gov registry (http://clinicaltrials.gov/) was evaluated by comparing the completeness of WHO 20-item Trial Registration Data Set items.
Results: Among the 15 clinical trials registries included in the study, 40.0% (6/15) of the clinical trials registries ignored the item of ‘date of first enrollment’, 26.7% (4/15) trials registries neglected the item of ‘secondary identifying numbers’, 20.0% (3/15) trials registries unnoticed of ‘Secondary Sponsor(s)’ and ‘Countries of Recruitment’ items. Only four clinical trials registries fulfilled all the 20 items in the WHO Trial Registration Data Set.
Conclusions: Clinical trials registration has the potential to improve clinical trial transparency and reduce publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records. The missing or uninformative entries of key information could be reduced by improving the quality of clinical trial registries.