Contract Research Organizations

Forrest WilliamsonBaylor University

Fall 2012 Colloquium Series

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

CROs: What are they and what do they do?

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)

CROs and Pharmaceutical Companies

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

DMC Report – closed version

Job Opportunities

(Bio)statisticianClinical Non-ClinicalStudy ManagementTraining programmersData enhancementEmergency unblindingHosting DMCs

Modeling & InferenceDesignResearchOutside trainingSimulations

Statistical ProgrammerCreating analysis

datasetsProgramming DMC

report elements (TLFs)

Performing statistical tests

SAS

What did I do?

TesterQuality 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

Quest

ions?