Forrest Williamson Baylor University Fall 2012 Colloquium Series.

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Presentation transcript:

Forrest Williamson Baylor University Fall 2012 Colloquium Series

Outline CROs: What are they and what do they do? CROs and Pharmaceutical Companies Independent Statistical Consulting Data Monitoring Committees (DMCs) Job Opportunities What did I do? (…no, really!) FDA

CROs: What are they and what do they do?

CROs Contract Research Organization “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.“ ICH-GCP (E6 1.20)

CROs and Pharmaceutical Companies

Independent Consulting $20 billion / year Smaller pharma companies Study Design & Power Interim & Final Analyses Larger pharma companies Interim Analysis Randomization codes

DMCs / DSMBs Data Monitoring Committee / Data Safety Monitoring Board Members 1 DMC chair 3-4 physicians/ clinitians 1-2 statisticians

DMC Open Sessions Sponsor allowed to participate Updates on enrollment and study status Explain interesting medical events Justify statistical methods chosen Look at all enrolled patients

DMC Closed Sessions Sponsor kicked out! Information given per treatment arm DMC members look for unusual events, differences between treatment arms Must make a suggestion to the sponsor to continue/ discontinue the study

DMC Report – closed version

Job Opportunities

(Bio)statistician Clinical Non-Clinical Study Management Training programmers Data enhancement Emergency unblinding Hosting DMCs Modeling & Inference Design Research Outside training Simulations

Statistical Programmer Creating analysis datasets Programming DMC report elements (TLFs) Performing statistical tests SAS 

What did I do?

Tester Quality control on DMC report elements Check programmer’s results with independent code Organize final reports Buffer between statisticians and programmers

What the heck, FDA?!

FIN Questions?