FDA defines clinical trials as voluntary research studies conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. The data generated is the most important and confidential to a clinical trial project as the fate of the drug, whether or not the drug will reach the pharmacy shelf, depends on it. A clinical trial is conducted in multiple centers and a large amount of data is generated which can be difficult to manage. Once the data is clean, a clinical study report should be written for submitting to regulatory authorities for product approval. Statistical Analysis Software (SAS) is a biostatistical tool used to manage and generate tables, listings and graphs for clinical study reports etc. Let’s discuss the basics of the SAS tool and its use in clinical domain.
SAS is a multi-domain application used to generate reports, tables, listings, 2D and 3D graphs, charts, etc. The major domains of SAS are SAS®/Clinical, SAS®/Finance, SAS®/Banking, SAS®/Advanced Analytics, SPSS®/Market Research, Excel/Analytics, Minitab etc. In clinical domain, SAS plays a major role in data analysis and thus in preparing the clinical study report. The SAS applications are in compliance with 21 CFR part 11, ICH, CDISC-SDTM, HL7, etc.
SAS environment has three windows namely, editor window, log window and output window. The editor window is used to write and execute the SAS program. The log window displays the backend execution of the program and error messages. The output window displays the output of the executed program. Every statement in SAS ends with semicolon, “;”.
The core functions of SAS in clinical trials include:
- Protocol Design and Study Start-Up
- Patient and Investigator Recruitment
- Clinical Trial Management
- Clinical Data Management
- Data Analysis
- Clinical Supplies
- Regulatory and Safety compliance
- Regulatory submissions
SAS play a major role starting from defining the clinical study to till regulatory submission. SAS can be integrated with the clinical trial management systems (CTMS) like Oracle Clinical. The data integration process starts with the extraction of data (Data Importing). Once the data is imported to SAS environment, the data is filtered and data cleaning takes place. Once the data is clean (error free), SAS tables are generated for analysis of the data. The clinical study report is compiled using data generated in the SAS environment. SAS also plays a role in protocol development, randomization process, IVRS/IWRS procedure, CRF designing, adverse event reporting etc.