SAS is a statistical analysis software primarily used as a data management, statistical analysis, and reporting tool. It was created at North Carolina State University in the late 1960s. The typical SAS workflow involves collecting data from databases, performing analysis and reporting in SAS, and submitting clinical trial data and results to regulatory agencies like the FDA. SAS plays a key role in organizing clinical trial data into CDISC standards like SDTM and ADaM and generating tables, figures, and listings for analysis and regulatory submission.

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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