Article type
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Abstract
Background: A number of clinical trials may not be published for a variety of reasons leading to publication bias. The need to request researchers and research institutions to register clinical trials at their inception in a publicly and universally accessible register has been proposed as a solution to mitigate outcome and publication bias. The Ottawa Group developed the Ottawa Statement Part 1 on the principles of trial registration and The Ottawa Statement Part 2 on the principles of implementation of trial registration. Despite the intense interest in this topic there is a wide gap between theoretical postulates on trials registration and the implementation of them. Several major barriers have been recognized to the development of clinical trials registers.
Objectives: We aim to evaluate trialists' views of the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO) and of the Ottawa Statement, as well as their disposition to provide information for future clinical trials of at least the 20 items (WHO Data Set) to a publicly accessible register.
Methods: PubMed was used for a structured search from January 2005 to December 2005 using a filter designed for human controlled clinical trials. The strategy was not limited by language or type of intervention. The search identified 40,158 references from which a random sample of 450 verified clinical trials were selected where an electronic address was available. Trialists from forty countries were included. The survey sought the following information: country of origin, informant's age, knowledge about trial registration, disposition to endorse the WHO International Clinical Trials Registry Platform and the Ottawa Statement, as well as the number of ongoing clinical trials and type of funding. In addition we will assess views on issues related to registration of trials results, key secondary outcomes and delayed public disclosure of some data.
Results and conclusions: The authors expect to provide useful information of trialists' disposition to endorse clinical trial registration.
Objectives: We aim to evaluate trialists' views of the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO) and of the Ottawa Statement, as well as their disposition to provide information for future clinical trials of at least the 20 items (WHO Data Set) to a publicly accessible register.
Methods: PubMed was used for a structured search from January 2005 to December 2005 using a filter designed for human controlled clinical trials. The strategy was not limited by language or type of intervention. The search identified 40,158 references from which a random sample of 450 verified clinical trials were selected where an electronic address was available. Trialists from forty countries were included. The survey sought the following information: country of origin, informant's age, knowledge about trial registration, disposition to endorse the WHO International Clinical Trials Registry Platform and the Ottawa Statement, as well as the number of ongoing clinical trials and type of funding. In addition we will assess views on issues related to registration of trials results, key secondary outcomes and delayed public disclosure of some data.
Results and conclusions: The authors expect to provide useful information of trialists' disposition to endorse clinical trial registration.