User login
A new study has revealed a lack of registration and publication of clinical trials, as well as discrepancies in the reporting of primary outcomes.
However, this study is limited in that it only included 113 clinical trials approved in Finland.
An-Wen Chan, MD, DPhil, of the University of Toronto in Ontario, Canada, and his colleagues reported findings from the study in JAMA.
The results were also presented at the Eighth International Congress on Peer Review and Scientific Publication.
The researchers examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes.
The team looked at 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.
Sixty-one percent of the trials were prospectively registered, which was defined as registration within 1 month of the trial start date to allow for incomplete start dates and processing delays in the registry.
Fifty-seven percent of the trials were published, and 80% had a defined primary outcome.
Prospective registration was significantly associated with subsequent publication, with 68% of registered trials and 39% of unregistered trials getting published (adjusted odds ratio=4.53 [95% CI, 1.12-18.34]).
In addition, registered trials were significantly more likely than unregistered trials to be published with the same primary outcomes as defined in the protocol—64% and 25%, respectively (adjusted odds ratio=5.79 [95% CI, 1.42-23.65]).
The researchers assessed discrepancies in primary outcomes between the protocol and the registry/publication. These were defined as:
- A new primary outcome being reported that was not specified as primary in the protocol
- A protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.
The researchers found discrepancies between the registry and the protocol in 23% of the prospectively registered trials. There were discrepancies between the publication and the protocol for 16% of published trials.
Discrepancies between the protocol and publication were more common in unregistered trials than registered trials—55% and 6%, respectively (P<0.001).
Based on these results, the researchers concluded that prospective registration should be mandatory for all clinical trials. 
A new study has revealed a lack of registration and publication of clinical trials, as well as discrepancies in the reporting of primary outcomes.
However, this study is limited in that it only included 113 clinical trials approved in Finland.
An-Wen Chan, MD, DPhil, of the University of Toronto in Ontario, Canada, and his colleagues reported findings from the study in JAMA.
The results were also presented at the Eighth International Congress on Peer Review and Scientific Publication.
The researchers examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes.
The team looked at 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.
Sixty-one percent of the trials were prospectively registered, which was defined as registration within 1 month of the trial start date to allow for incomplete start dates and processing delays in the registry.
Fifty-seven percent of the trials were published, and 80% had a defined primary outcome.
Prospective registration was significantly associated with subsequent publication, with 68% of registered trials and 39% of unregistered trials getting published (adjusted odds ratio=4.53 [95% CI, 1.12-18.34]).
In addition, registered trials were significantly more likely than unregistered trials to be published with the same primary outcomes as defined in the protocol—64% and 25%, respectively (adjusted odds ratio=5.79 [95% CI, 1.42-23.65]).
The researchers assessed discrepancies in primary outcomes between the protocol and the registry/publication. These were defined as:
- A new primary outcome being reported that was not specified as primary in the protocol
- A protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.
The researchers found discrepancies between the registry and the protocol in 23% of the prospectively registered trials. There were discrepancies between the publication and the protocol for 16% of published trials.
Discrepancies between the protocol and publication were more common in unregistered trials than registered trials—55% and 6%, respectively (P<0.001).
Based on these results, the researchers concluded that prospective registration should be mandatory for all clinical trials.
A new study has revealed a lack of registration and publication of clinical trials, as well as discrepancies in the reporting of primary outcomes.
However, this study is limited in that it only included 113 clinical trials approved in Finland.
An-Wen Chan, MD, DPhil, of the University of Toronto in Ontario, Canada, and his colleagues reported findings from the study in JAMA.
The results were also presented at the Eighth International Congress on Peer Review and Scientific Publication.
The researchers examined adherence to trial registration and its association with subsequent publication and reporting of primary outcomes.
The team looked at 113 clinical trial protocols approved in 2007 by the research ethics committee for the region of Helsinki and Uusimaa, Finland.
Sixty-one percent of the trials were prospectively registered, which was defined as registration within 1 month of the trial start date to allow for incomplete start dates and processing delays in the registry.
Fifty-seven percent of the trials were published, and 80% had a defined primary outcome.
Prospective registration was significantly associated with subsequent publication, with 68% of registered trials and 39% of unregistered trials getting published (adjusted odds ratio=4.53 [95% CI, 1.12-18.34]).
In addition, registered trials were significantly more likely than unregistered trials to be published with the same primary outcomes as defined in the protocol—64% and 25%, respectively (adjusted odds ratio=5.79 [95% CI, 1.42-23.65]).
The researchers assessed discrepancies in primary outcomes between the protocol and the registry/publication. These were defined as:
- A new primary outcome being reported that was not specified as primary in the protocol
- A protocol-defined primary outcome being omitted or downgraded (reported as secondary or unspecified) in the registry or publication.
The researchers found discrepancies between the registry and the protocol in 23% of the prospectively registered trials. There were discrepancies between the publication and the protocol for 16% of published trials.
Discrepancies between the protocol and publication were more common in unregistered trials than registered trials—55% and 6%, respectively (P<0.001).
Based on these results, the researchers concluded that prospective registration should be mandatory for all clinical trials.