Recommendations to improve adverse event analysis and reporting in clinical trial report publications
Recommendation | |
Analysis | Incorporate objective statistical methods to assist the evaluation of adverse event information. |
Consider avoiding dichotomising continuous data. | |
When count outcomes are available (such as repeated events within participants) use appropriate statistical methods. | |
Clearly define exposure and specify a suitable safety analysis population. | |
Use graphical approaches to help summarise large amounts of data. | |
Reporting | Report adverse event data according to the CONSORT harm checklist. |
Increase the uptake of mandatory submission of CONSORT harm by journals. | |
Include a relevant summary of the adverse event profile in the main article. Resist depositing all adverse event data into appendices without summarising. |
CONSORT, Consolidated Standards for Reporting Trials.