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Application of SAS in Clinical Trials

Epoch Research Institute India Pvt. Ltd Speaker: Mr. Saumil Tripathi

Agenda
About Clinical Trial Clinical Trial Data Role of SAS in Clinical Trial Clinical SAS Work Process Different Modules of SAS to Learn SAS Clinical Trial Certification Exam SAS Life Science Industry Framework

What is Clinical Trial ?


A clinical trial is a type of research carefully designed to determine the effectiveness and safety of a drug or device in humans.

Not precisely.!!!

Clinical Trial
Clinical Trials are planned experiments which involves patients and is designed to elucidate the most appropriate treatment of future patients with a given medical condition.

Clinical Trial in Nutshell

Phases of Clinical Trial


Clinical Trail is Basically divided in to Four Phases
Phase I Phase II Phase III Phase IV

Clinical Trail : Phase I


Phase 1: Small studies conducted in healthy volunteers. These studies are usually uncontrolled and open labeled.
Initial tolerability and safety Pharmacodynamics Dose-finding Pharmacokinetics Bioequivalence studies (these are usually doubleblind crossover studies) Food interaction/drug interaction studies

Clinical Trail : Phase II


Phase 2. Small to moderate sized trials (usually controlled double or triple blinded) studies in patients.
Safety and tolerability Preliminary efficacy. These trials are done with 80% power. Dose-ranging. Find the dose that produces the optimal outcome.

Clinical Trail : Phase III


Phase III studies are randomized controlled multicenter

trials on large patient groups and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

Clinical Trial: Phase IV


Post Marketing Surveillance
Another jumble of studies, of which clinical trials are a minority. By and large these are descriptive, case-control or cohort studies.
1. 2. 3. 4. Surveillance Answer FDA inquiries Cost effective analyses versus other treatments Validation studies for rating scales

Licensing and Regulatory authorities


Drug Controller General of India (DCGI)-IND

Food and Drug Administration (FDA) US


European Medicines Evaluation Agency (EMEA) - EU Ministry of Health and Welfare (MHW) Japan

Medicines and Healthcare products Regulatory Authority (MHRA) - UK

Data of Clinical Trial

Data of Clinical Trial

Interventions

Events

Findings

Exposure

AE

Labs

Incl Excl*

ConMeds

Disposition

Vitals

Subj Char*

Subst Use*

MedHist

PhysExam

ECG

QS*, MB*

CP*, DV*

What is the Role of SAS?


Basic Research
Statistical analysis Graphics Reporting

Clinical Trial
Randomization program SAS database SAS documentation Statistical analysis Graphics Reporting

Basic Concept of SAS


SAS is language-based program. It involve two main component.
DATA STEP and PROC STEP.

DATA STEP
dataset manipulation to prepare data analysis

PROC STEP
perform the particular Analysis or Function.

Clinical SAS Work Process


Import data from disparate sources Base SAS Advance SAS Transform data into useful analysis data structures. SAS Report/ Graph/ Access

Create tables, figures, and listing to support clinical reporting

Export data and reports to sponsor, FDA, and other clients

Import Data From Various Source


Type of DATA
Scale of data can be ranged from small to large Small scale such as ASCII Text, Microsoft Excel, Microsoft Access Large scale Relational Database such as Microsoft SQL database or ORACLE database

Clinical SAS Work Process


Import data from disparate sources

Transform data into useful analysis data structures.

Create tables, figures, and listing to support clinical reporting Export data and reports to sponsor, FDA, and other clients

Data Manipulation
Entering data into a data set; Taking a subset of the observations; Taking a subset of the variables; Adding a new variables; Combining several operations; Multiple output data sets; Concatenation; merging and updating.

Transforming the Data


Key concepts for creating Analysis Data sets
Define Variable Once Defining Study Population Defining Baseline Observations Defining Study Day Windowing Data Transposing Data

Clinical SAS Work Process


Import data from disparate sources

Transform data into useful analysis data structures.

SAS documentation Analysis Plan

Create tables, figures, and listing to support clinical reporting

Export data and reports to sponsor, FDA, and other clients

Analysis Plan
For each study, a specific Protocol will define the objective and statistical method. Classifying Data for reporting
Demographics and Trial-specific baseline data Laboratory data, Adverse Event Data, Endpoint Assessment Treatment Randomization Data Quality-of-Life Data

SAS Documentation
For each study, SAS documentation can
Describe the SAS database structure; Explain the meaning of each variables; List out the coding of each variables.

Moreover, a SAS program consist of various DATA and PROC step to perform particular tasks (baseline table, Event table and Endpoint Summary)
Self-explain the flow of (windowing data and transposing data) to become the final output is necessary.

Clinical SAS Work Process


Import data from disparate sources

Transform data into useful analysis data structures.

Create tables, figures, and listing to support clinical reporting

Export data and reports to sponsor, FDA, and other clients

Generating Tables & Listings


PROC FREQ PROC TABULATE PROC REPORT

Example PROC FREQ

PROC TABULATE - Toxicity Table by ARM

Create a Graph
PROC GPLOT and PROC GCHART Common graphics
Scatter Plot Line Plot Box Plot Bar Chart Odds Ratio Plot Kaplan-Meier Survival Plot

Example: Scattered Plot

Example: Bar Chart

Survival Curve

Listing Reports

Summary Report

Courses Offered by SAS


Base SAS Advance SAS SAS Report SAS Graph SAS Stat I: Introduction to ANOVA , Regression & Logistic Regression Statistics 2: ANOVA and Regression SAS Clinical Data Integration

Courses offered by SAS


Base SAS
This course is for users who want to learn how to write SAS programs. It is the entry point to learning SAS programming and is a prerequisite to many other SAS courses. This course helps you prepare you for the following certification exam(s): SAS Base Programming Exam for SAS 9.

Advance SAS
This course is for SAS programmers who prepare data for analysis. The comparisons of manipulation techniques and resource cost benefits are designed to help programmers choose the most appropriate technique for their data situation. It focuses on the components of the SAS macro facility. It also covers how to process SAS data using Structured Query Language (SQL).

Courses offered by SAS


SAS Report Writing 1: Essentials
This course teaches you how to create detailed tabular, summary, and listing reports. You also learn how to send report output to the major Output Delivery System (ODS) destinations.

SAS Graph:
Design graphs that describe their data in the most appropriate fashion customize default graph elements such as axes and legends, apply annotations that supplement the features available with SAS/GRAPH procedures, deliver graphs in multiple formats, such as static image files and client-generated images.

Courses offered by SAS


STATISTICS I & II: Introduction to ANOVA Regression & Logistic Regression
generate descriptive statistics and explore data with graphs perform analysis of variance and apply multiple comparison techniques perform linear regression and assess the assumptions identify potential outliers in multiple regression detect associations among categorical variables fit a multiple logistic regression model.

Course offered by SAS


SAS Clinical Data Integration Using the clinical features, this course shows how to import CDISC
standards (or other standards) for domain structure and contents into the metadata, Build clinical domain target table metadata from those standards, create jobs to load clinical domains, To validate the structure and content of the clinical domains based on the standards. Generate CDISC standard define.xml files describing the domain tables for clinical submissions.

SAS CertificationsAdd value..


Base SAS Certification Advance SAS Certification Certified Clinical Trail Programmer
This is a new certification exam launched in 2011 which evaluate candidates as a Clinical SAS Programmer. This certification covers most of the task associated with the Clinical SAS Programmer. SAS is the de facto industry standard for clinical data analysis and reporting in the life sciences/pharmaceutical industry. This credential validates a candidates' ability to apply SAS programming skills to clinical trials data.

Benefits of Certification
Whats in it for ME.
Increase career opportunity and marketability to employers Enhance credibility as technical professionals Assess knowledge of SAS software Earn industry recognition for their knowledge Help managers differentiate the most qualified technical professionals Assist in defining employee learning paths Help to increase individual and workgroup productivity levels

SAS Life Science Industry Frame Work

SAS Industry Framework

SAS Industry Framework


Life Sciences

SAS Industry Framework


Life Sciences

Student Testimonial
Khushbu Shah
SAS is a bridge that linked my education with the clinical research industry. . Its considered to be one of the most important tools for Clinical Data management; Epoch Research Institute became my stepping stone. I would like to share a proverb here There is no substitute to hard work, Each key person at epoch works very hard and are very dedicated to all the students. Epoch provides best of the training and show a realistic view of the industry which helped me to get placed at my dream company, GSK!!!

Student Testimonial

Student Testimonial

Epoch Research Institute India Pvt. Ltd


Epoch Promoting excellence in SAS software training Training Center that meets these high standards set forth by SAS receives the Accredited Training Status. Training that keeps pace with technology SAS Accredited Training is your guarantee that you will benefit from a rapid and lasting return on your investment.
Four Components of SAS Accredited Training: SAS SOFTWARE SAS OFFICIAL CURRICULUM. TRAINING FACILITY INSPECTED APPROVED BY SAS SAS ACCREDITED TRAINING CENTER.

EPOCH RESEARCH INSTITUTE


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