Improving the Standards of Reporting of Clinical Trial Data

Although checklists and guidelines for reporting and interpretation of clinical trial results are of immense value there is still room for a biased presentation in journal publications. Two important sources of bias that remain are as follows: (1) The absence of a principle guiding the display of point estimates in abstracts. For example, bias arises, even for a primary endpoint, when the reported point estimate is preferentially selected and does not correspond to the prespecified method of analysis. The benefit of treatment on an endpoint is often communicated through point estimates, and as abstracts contain the main takeaways, establishing ground rules for what to include and what not to include is crucial. (2) A commingling in the body of the publication of results from α-controlled endpoints, non-α-controlled endpoints, and post hoc analyses. The total number of non-α-controlled and post hoc analyses are unknown. Blending a favored selection of these with α-controlled results provides opportunities to overstate or understate findings as desired. Publicly available results provide the grist for the changes proposed to improve reporting standards. Additional changes are recommended as well, including a threshold of significance more stringent than 0.05 for non-α-controlled analyses. For safety, the proposal is to display the data via the mean cumulative function graph for prespecified adverse events of interest. The bottom line is that more objective reporting can be achieved if journals establish standards for reporting of point estimates in abstracts and require a hierarchical display of results in the main body.