BizInt Cookbook of Reports & Visualizations

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Creating a Milestone Timeline [Trials CT-13] How did we create this?

START WITH: Any supported clinical trial data already displayed in BizInt Smart Charts. In this example we used: A combined chart with ClinicalTrials.gov and TrialTrove. Topic = COVID-19 vaccine trials for children and adolescents.

BIZINT SMART CHARTS DRUG DEVELOPMENT SUITE 1.

Display the columns used for the timeline: Use View | Apply Template and choose “BizInt Editor’s Choice - Multi-Database.” This provides a good starting point and ensures standard names for columns. Alternatively, use View | Choose Columns to add necessary columns. 2. Add a column for the lane labels : E dit | Add Column . This creates a new Untitled column at the end of your chart. Double click on the column header and change the name. Enter content in the new column to create a category column for thelanes of the timeline. To enter a line break in the labels use a pipe symbol: | For this example we use the name “Vaccine - sponsor” and enter vaccine and sponsor information for each trial. Alternatively, you can use View | Choose Columns to add a field you want to use to determine the lanes, such as Phase or Overall Status. 3. Add Columns for the milestones : Edit | Add Column . Double click on the column header and change the name to “Milestone Data.” Repeat to add two more columns - “Milestone Text” and “Milestone Type”. 4. Add milestone data : Enter data for all three milestone columns for each trial associated milestone you want to include. For multiple milestones for the same trial, enter the information for additional milestones on a new line. 5. Create the milestone subtable : Use Tools | Create Subtable from Columns . Add the three new milestone columns in order: Milestone Date, Milestone Text, and Milestone Type. Click Apply to create the subtable. 6. Select File | Send to Reference Rows . BIZINT SMART CHARTS REFERENCE ROWS 7. Use File | Export to export as VantagePoint - Smart Charts Edition. VantagePoint - Smart Charts Edition (VP-SCE) should open and import the file. If VP-SCE does not launch automatically, launch it and choose the option to import the .vpxi file. VANTAGEPOINT - SMART CHARTS EDITION - create the milestone timeline 8. Normalize phase : Right-click on the phase field and choose Thesaurus. Under Thesaurus, select DrugDevelopmentPhases_ Arabic and click OK. Note: if you don’t see this file, click on the folder icon and go up one level to VantagePoint - SCE and select the Thesaurus folder. 9. Create bar labels : Under the Refine tab, click on Concatenate Fields. We choose Phase (1) as the First Field and Subject Age as the Second Field. Click OK and then enter a colon followed by a space “: “ as the string between the terms and click OK. 10. Create Bar Category Field : Return to the Summary Sheet. Right-click on Subject Age and choose List Cleanup. On the List Cleanup panel click OK to go to the Dual View Cleanup Confirmation panel. Drag and drop to group similar items. Then right click on each top level item and choose Rename Item. Enter a name for the group, such as “Children” and “Teens & Adults” in our example. Click Accept when you are done. You can skip saving as a thesaurus. 11. Cleanup start and end dates : Return to the Summary Sheet. Right-click on the completion date field and select Further Processing | Read Until - First | Paren . Return to Summary Sheet and repeat with the Completion Date. 12. Create the Milestone Timeline : Under the Report tab, click on Milestone Timeline. Select the fields you want to use. • Milestone Data: The custom subtable containing the data for the milestones (Milestone Data in this example). • Custom Global Milestones: Added text and date for custom milestones. Click the plus sign to add each milestone. • Chart Title and SubTitle: Title and subtitle for the chart. These can be edited after the timeline is created, 13. Click on the Create Timeline button to open your trial completion timeline in a VP-SCE window. In VP-SCE, you can click on each box to get more detail. 14. Export the timeline : To save, click the Export Image camera icon and choose HTML to edit it. 21 PAGE • Field for the Lane Labels: used to label the lanes on the left of the timeline (e.g. Vaccine - sponsor). • Starting Date and Ending Date: the cleaned dates (e.g. Completion Date: Read Until - First/Paren) • Bar Label Field: used to label trials bars (e.g.Phase (1): Subject Age in this example) • Bar Category Field: : used to color code the trialb ars (e.g.Subject Age (Cleaned) in this example).