Clinical Meta-Analysis

The second tool in Custom Analytics is the Clinical Meta-Analysis tool. Powered by Advera’s Clinical Evidence Database containing the safety results of 14,000+ clinical trials, this analytic creates on-demand meta-analyses to determine AE rates across any combination of drugs, classes, indications, mechanisms of action, duration of treatment, adverse events, trial phase, or comparator drug. This allows users to quickly determine pooled adverse event rates, odds ratios, and p-values for safety issues of interest. Adverse event rates can be aggregated at the MedDRA Preferred Term, System Organ Class, or Standardized Medical Query level. 

Complex searches can be easily performed using the “AND,” “OR,” and “NOT” Boolean connectors. 

This allows users to: 

Users can access the Clinical Meta-Analysis tool by clicking the blue “Clinical Meta-Analysis” button below the universal search bar on the Evidex home screen. 

Or, from any other page in Evidex, click on “Custom Analytics” near the top right corner of the screen and then select “Custom Meta-Analysis” from the drop-down menu.
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Performing a Search
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Users may edit the selections for the four drop-down menus at the top of the search form: Adverse Event Type (Serious or Other); Output Options (Display Drug Summaries, Display Drug Combinations, or Meta-Analysis view (w/Forest Plots)); MH (Mantel-Haenszel) OR (Odds Ratio) Calculation (Haldane) Correction (Set at 0.5 as default, users can adjust up or down); and Count Trials with Zero Results for all Arms (No or Yes). (Note: the Haldane correction is applied to correct for potential instances of issues with a denominator of zero. 0.5 is the standard used across Evidex, though in this tool it can be lowered to show more sensitive results. “Count Trials with Zero Results for all Arms” is set as “No” as a default, since including trials with no results for a particular AE can considerably affect the Treatment Rate and Odds Ratio calculations.)

Display Drug Summaries is the default Output Option, which will return results showing a summary of patient counts, treatment rate, Odds Ratio (OR), p-value, etc. for the individual drugs. There will also be a list of individual Trial Results, showing details for each arm of the trial. 

Display Drug Combinations is another Output Option, which will return results showing each drug combination as a separate line item, each with patient counts, treatment rate, Odds Ratio (OR), p-value, etc. There will also be a list of individual Trial Results, showing details for each arm of the trial. 

Display Meta-Analysis View (w/Forest Plots) is the third Output Option, which will return results showing a Forest Plot for each trial result as well as the overall results from all trials matching the entered criteria. Forest plot charts can be downloaded in PNG or PDF format. 

To begin a search, users must select a field from the drop-down “Fields” menu. A drug, indication, mechanism of action, or drug class selection must then be typed into the search bar and selected. Users can then click the blue “AND/OR/NOT” button to add layers to their search and make further field selections. The search below is looking at one drug and one adverse event, in the Meta-Analysis View w/Forest Plots Output Option.

Clicking on the blue “Search Options” button in the upper right corner of the form allows users to Clear the Form, Save their analysis, or view their list of Saved Analyses. 

The summary text box at the bottom of the form will describe the search criteria parameters that have been entered. 

When all selections have been made, click the blue “Search” button at the bottom right corner of the form. 

Results

A summary text box at the top of search Results describes the search criteria entered from the previous form. Users can click the blue Search Options button at the top right corner to create a New Analysis, Refine the current Analysis, Save as a new search, or view Saved Analyses. 

Under the Final Results header, users can view the Background Rate calculation, which includes the pooled rate for all of the trials in the database that match the criteria. The MH OR Rate section displays the pooled rate for all of the trials that match the criteria, that also have a control arm (since a control arm is a required piece for an OR calculation). 

Clicking on an NCT ID will bring users to the respective Trial Page within Evidex. Clicking on a Drug Name will bring users to the respective Drug Page within Evidex. Users can download data tables and make column display selections by clicking the three-line menu in the upper right corner of a data table. 

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