Post on 01-Jan-2016
description
OutlineCROs: What are they and what do they do?CROs and Pharmaceutical Companies
Independent Statistical ConsultingData Monitoring Committees (DMCs)
Job OpportunitiesWhat did I do? (…no, really!)FDA
CROsContract 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)
Independent Consulting$20 billion / yearSmaller pharma
companiesStudy Design & PowerInterim & Final
AnalysesLarger pharma
companiesInterim Analysis
Randomization codes
DMCs / DSMBsData Monitoring
Committee / Data Safety Monitoring Board
Members1 DMC chair3-4 physicians/
clinitians1-2 statisticians
DMC Open SessionsSponsor allowed to
participateUpdates on
enrollment and study status
Explain interesting medical events
Justify statistical methods chosen
Look at all enrolled patients
DMC Closed SessionsSponsor kicked out!Information given per
treatment armDMC members look
for unusual events, differences between treatment arms
Must make a suggestion to the sponsor to continue/ discontinue the study
(Bio)statisticianClinical Non-ClinicalStudy ManagementTraining programmersData enhancementEmergency unblindingHosting DMCs
Modeling & InferenceDesignResearchOutside trainingSimulations
Statistical ProgrammerCreating analysis
datasetsProgramming DMC
report elements (TLFs)
Performing statistical tests
SAS
TesterQuality control on
DMC report elements
Check programmer’s results with independent code
Organize final reports
Buffer between statisticians and programmers