SAS Programming in Clinical Research for Drug Development

SAS Programming in Clinical Research for Drug Development

 Subrahmanya Rajeev Dhulipala, V Dhanush
Student

Dept of Electronics and Communication Engineering

R.V. College of Engineering, Benguluru dsubrahmanyar.ec19@rvce.edu.in

Dr. Geetha K.S.
Professor & Vice-Principal

Dept of Electronics and Communication Engineering

R.V. College of Engineering, Benguluru geethaks@rvce.edu.in

Abstract—In this paper, a study data tabulation in the demo- graphics domain from the vast amount of clinical trial data in accordance to the SDTM Specification sheet provided by CDISC has been generated. SDTM specifies a standard format for study data tabulations that must be submitted to a regulatory body like the Food & Drug Administration (FDA) for drug review. Statistical Analysis Software (SAS) programming was used to extract demographic data from a clinical trial that was double- blinded and randomly assigned. It involves creating datasets for the demographics domain using SAS programming in-line with the SDTM specification. Tables, Lists, and Figures (TLFs) using SAS programming in relation to the study variables were also created. The following data can be used for analyzing a drug with a potential of diabetes prevention. It is used for determining the safety & dosage range, the toxicology and side effects of the investigational drug. These generated datasets& TLFs can be used as a part of drug review for the regulatory agencies.

Index Terms—Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), Statistical Analysis Software (SAS), Tables Lists and Figures (TLFs), Food & Drug Administration (FDA) .