Introduction to clinical sas

1. Introduction to
Clinical SAS
Vijayaraghava K

2. Agenda
• Introduction to SAS
• SAS workflow
• Applications
• Clinical Domain
• Clinical trial phases
• Clinical trial data collection
• Types of clinical trial data
• Regulatory Agencies
• SAS role in data submission
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3. Introduction to SAS
• SAS stands for Statistical Analysis
Software
• It is primarily used as a data management,
statistical analysis and reporting tool
• Started at North Carolina State University
as a project to analyze agricultural
research by Jim Goodnight in late 1960s
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4. Workflow
databases
SAS
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5. Clinical Domain
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6. Clinical Trial Phases
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7. Clinical Trial Data Collection
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8. Types of Clinical Trial data
•Demographic Data
•Age, Sex, Race, Country
•Pharmacokinetic Data
•AUC, T-half, Cmax, Tmax
•Exposure Data
•Study Drug
•Other than Study Drug
•Substance Use
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9. Types of Clinical Trial data
•Safety Data
•Adverse Events, Laboratory, Vital
Signs, Electrocardiogram, Physical
Examination and Others
•Efficacy Data
•Depends on Therapeutic Area
•Cancer - Tumor size, Survival
•Other Data
•Deviations, Milestones
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10. Clinical Trial Road map
R & D
CRO
CDM
SAS Programmer
Client
FDA
Statistical Analysis
Plan
• CDM to CDISC Standards
• Raw data to SDTM
• SDTM to ADaM
• TLFs
• Data Submission
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11. Example of Analysis :
Demographic Table for Oncology
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12. TEAE by SOC and PT
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13. Summary of Hematology Laboratory Values
by Time point and Treatment Group
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Regulatory Agencies
• USA: Food and Drug Administration (FDA)
• Europe: European Agency for the Evaluation of Medical
Products (EMEA)
• Japan: Ministry of Health and Welfare (MHW)
• Others
• Canada: Therapeutic Products Directorate (TPD)
• Australia: Therapeutic Goods Administration (TGA)
• China: State Drug Administration (SDA)
• India: Drug Controller General of India (DCGI)

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Any Queries ??