Phase 1 Primary End Point is Safety
Phase 2 End Point is Efficacy
Phase 3 End Point is Efficacy with fewer Mortality.
Phase 4 End Point is Efficacy – Post-Marketing or Spontaneous reports.
What is Suspected Unexpected Serious Adverse Reaction (SUSAR)?
An “Unexpected” Serious Adverse Event “Related” to the Study Drug. You got to send the CIOMS to the Health Authority.
What is DSUR or PSUR or PBRER?
JReview and SpotFire Comparison:
|Graphic Patient Profile||End-User can create on the fly.||Require IT Support help|
|Patient Review Tracking||Keep track of patients reviewed.||Not Available.|
|Tabular Patient Profile||Spreadsheet-view with ‘New Data’ hightlights||Not Available.|
|Formated Patient Profile||PDF-view. Similar SAS output. Can be scheduled as Batch-run||Not Available.|
|Patient view||Can view Graph and Spread-sheet view of patient(s)||Better than Jreview’s view. But requires IT support help.|
|SAS as Data Source||Available||Available (bit slower)|
|Date wise Patient report||Available||Not Available.|
|Graphical view||Many type but still not pretty enough||Better looking Graphs|
|Benefit Risk Analysis||High level overview of benefit and risk of the trial||Under construction|
|Baseline and Endpoints||Can be defined at the study/project level by an Admin||Can be defined for each report.|
|SAS programs||Can register and execute SAS programs||Not Available.|
|Patient Narratives||Wow.. Factor!||Not Available.|
|Multi-study analysis||Can choose more than one study||One study at a time.|
|Output||Same as above. Can work and save output for multi-study||One study at a time.|
|Setup||Built based on the Clintrial and OC-like product||Vanila. Tell the where the views are.|
How to pass user-enterd (Parameter) values in to JReview ImportSQL?
1) Add &PromptText (for number) or ‘&PromptText’ (for Char and Date)
Select Study, Site, Patient, SubjInit, Sex, Race from DM Where Sex = ‘&EnterSex’
Bug: You cannot add succeeding “another Where clause” or “space” or “Enter key” after the ‘&prompt’.
Where sex = ‘&EnterSex’ and Age > 18
But it would work for Numerical Prompt. Where age > &EnterMinAge and Sex = ‘M’
2) Add <prompt=>
Instead of using &prompt, you can use <prompt=>.