The number of cases included in registry publications was larger by a factor of 1.3, and was thus in a comparable range.
There should be clear documentation on the management structure and key personnel of the registry, a description of inclusion or exclusion criteria, a data dictionary, documentation guiding the collection and further processing of data, a data access policy, documentation on confidentiality and ethics issues and copies of all registry publications.
Although only 10% of the publications had major discrepancy between trial registry and publication, smaller changes are frequently made to the final presentation of the data that are not reflected in the registry of the trial.
Researchers may be reluctant to publish results in a registry before publication in peer-reviewed journals, even if the journals would accept such pre-publication [ 19].
To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA).
One trial did not list a secondary outcome measure in the registry or publication [ 24].
Discrepancies between trial registry and publication have been observed in previous studies and are a concern as they may compromise the integrity of the conclusions that can be drawn from the study [ 31].
The draft Annual Statistical Monitoring Report is discussed by the Committee, and approved by registries, before publication.
These numbers have to be supplied in each registry-derived publication, and the quality of the registration process must be continuously validated.
This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.
