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Abstract
The International Collaborative Group on Clinical Trial Registries (ICG-CTRs) held its inaugural meeting in Brussels in 1991. The meeting was sponsored by the European Economic Community. The rationale behind the establishment of the ICG-CTRs was to provide a common interest group with a tool for the exchange of ideas and experiences on registries clinical trials at inception. During this meeting an ad hoc Steering Committee was named. Several proposals were made and these have been published in the form of a consensus statement and an article.
It was decided to establish contact with all existing registry holders, to invite them to join the group. Since the initial meeting two meetings have been held and the third is planned during the Cochrane Colloquium. Several members were active in the recent NIH conference on clinical trial registries held in Bethesda in December 1993. During this meeting the rationale for registries was reviewed, and the problems involved in the setting up and running of registries were explored.
One of the aims of the ICG-CTRs is to provide information on trials to be performed in all areas of medicine involving all types of therapies. Registration of trials before they start enables the scientific community to know they exist whether the results from the trials are published or not, and whether these results are positive or negative. We feel that trial registries should contain a core set of data, and that all registered trials should be given a unique number that should be cited on all publications. The numbering system should be unified so that the registry involved can be easily recognised. The experience of members of the Group should be available to others wishing to set up registries in the area of interest. The Group has drafted a core content of data to be registered and guidelines for the operation of such registries. Among the tasks to be undertaken in the future are: 1) guidelines for registration using computerised networks (eg bitnet); and 2) lobbying to make early registration of trials acceptable to sponsors.
It was decided to establish contact with all existing registry holders, to invite them to join the group. Since the initial meeting two meetings have been held and the third is planned during the Cochrane Colloquium. Several members were active in the recent NIH conference on clinical trial registries held in Bethesda in December 1993. During this meeting the rationale for registries was reviewed, and the problems involved in the setting up and running of registries were explored.
One of the aims of the ICG-CTRs is to provide information on trials to be performed in all areas of medicine involving all types of therapies. Registration of trials before they start enables the scientific community to know they exist whether the results from the trials are published or not, and whether these results are positive or negative. We feel that trial registries should contain a core set of data, and that all registered trials should be given a unique number that should be cited on all publications. The numbering system should be unified so that the registry involved can be easily recognised. The experience of members of the Group should be available to others wishing to set up registries in the area of interest. The Group has drafted a core content of data to be registered and guidelines for the operation of such registries. Among the tasks to be undertaken in the future are: 1) guidelines for registration using computerised networks (eg bitnet); and 2) lobbying to make early registration of trials acceptable to sponsors.