Analysis of Safety Data Is More Enough?. Marc Andersen Senior Statistician. Outline / Conclusion. Analysis - For what purpose Different usages Approaches and issues Best practice to be developed Is more enough? It's needed Consolidation of methods
Analysis - For what purpose
Approaches and issues
Is more enough?
Some slides will be skipped, but present in handout
*: examples will be shown separately
Used for different purposes:
May claim that ISS corresponds to eCTD section 2.7.4
Absense of Evidence is not Evidence of Absence
Alderson, BMJ editorial, 2004, http://bmj.bmjjournals.com/cgi/reprint/328/7438/476
Altman, Bland, BMJ Letter, 2004, http://bmj.bmjjournals.com/cgi/content/full/328/7446 /1016-b,
Altman, Bland, BMJ Statistics notes 1995, http://bmj.bmjjournals.com/cgi/reprint/311/7003/485
Attributed to Carl Sagan http://www.quotationspage.com/quote/37901.html
Lareb is the centre for knowledge about adverse drug reactions in the Netherlands. The government has instructed us to register and analyse the adverse drug reactions from drugs and vaccines:
Google search: adverse drug reactions data mining
Consider implications for integration
Ideal: SAS set statement combines the study datasets:
set lab001 lab002 lab003 ...;
Get an overview early
Overview of study characteristics *
FDA: Regulatory Submissions in Electronic Format; New Drug Applications (Issued 1/1999, Posted 1/27/1999) (IT3) http://www.fda.gov/cder/guidance/2353fnl.pdf (not recent, but still relevant)
CDISC, CDISC Submissions Data Model Version 2.0, http://www.cdisc.org/publications/index.html
Question: when is domain = dataset?
Has the same conventions been used in all studies
Tip: usefull to list CIOMs numbers with AE’s *
Question: Cross over studies?
Issue: multiple events per patient; first event only?