Epoch Research Institute : Introduction to CR

Application of SAS in Clinical Trials
Epoch Research Institute India Pvt. Ltd

Agenda
• About Clinical Trial
• Clinical Trial Data
• Role of SAS in Clinical Trial
• Clinical SAS Work Process
• 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.

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.”

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 I:
• 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 double-blind
crossover studies)
– Food interaction/drug interaction studies

Clinical Trail : Phase II
• Phase II:
• 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
• 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. Surveillance
2. Answer FDA inquiries
3. Cost effective analyses versus other treatments
4. 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
Interventions Events
ConMeds
Exposure AE
MedHist
Disposition
Findings
ECGPhysExam
Labs
Vitals Subj Char*
Subst Use*
Incl Excl*
QS*, MB* CP*, DV*

What is the Role of SAS in Clinical Research?
• Basic Research of the data captured in Clinical Trial
– Statistical analysis
– Graphics
– Reporting
• Clinical Trial
– Randomization program
– SAS database
– SAS documentation
– Statistical analysis
– Graphics
– Reporting

What is the Role of SAS in Clinical Research?
• After the data capturing from the patients in
to the Clinical Trials. It has to be analyzed
before the submission to US FDA or any
regulatory body.
• SAS is providing that solution to all
pharmaceutical and Clinical research
Industry for accessing, managing ,analyzing
and Reporting clinical data in accurate way.

The Importance of Data
archived
Accurate data are the key to a successful trial !
measured
Data must be accurately
Recorded
Entered in CRF verified
publishedanalyzed

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.

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

Data Manipulation by SAS
• 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 by SAS
• Key concepts for creating Analysis Data sets
– Define Variable Once
– Defining Study Population
– Defining Baseline Observations
– Defining Study Day
– Windowing Data
– Transposing Data

Statistical 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.

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

SAS Life Science Industry Frame
Work

SAS Initiatives in Life Sciences
• What are the most pressing technology
issues facing life sciences?
0
5
10
15
20
25
30
35
# Mentionsons
Better data integration
tools
Development of
data standards
Data storage and
archiving

SAS Industry Framework
Life Sciences

Application of SAS®
• Compliance & Standards
• Clinical Trial Data Management & Analysis
• e-submissions
• Genomics Research
• Safety

The Solution – Pre Clinical & Clinical Trial Data Mart
EDC
CDMS
CRO
LIMS
Multi–Trial Data Sources
EDC: Electronic Data Capture
CDMS: Clinical Data Management System
CRO: Contract Research Organization
LIMS: Laboratory Information Management System
Clinical Trial
Data Mart Trial Reports – Control Group
Report , Affected Group Report
Trial Metrics
Trial Analysis
Cross – Trial Analysis
Extract,
Transform,
Cleanse &
Load source
data
Analysis

SAS Drug Development
• Enables regulatory compliance for data extraction,
transformation and statistical analysis processes.
• Provides a centralized, controlled, repository for
source data, derived data, analyses, reports,
programs, logs, templates, documents and other
research content.
• Integrates with existing systems to provide
information management and compliance across the
research value chain.
• Allows non-technical users to interactively explore
research data as appropriate.

SAS Drug Development
• Easily extended to work with other industry
technologies
• Actively supporting open standards
• Integrated analysis
• Integrated exploration
• Integrated compliance

 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.

Contact Us:
Epoch Research Institute India Pvt. Ltd.
B-603 , Shapath IV, Opp. Karnavati Club,
S.G. High way , Ahmedabad.
Ahmedabad: 079-40327000 || Bangalore : 080-49077000

Epoch Research Institute : Introduction to CR

Epoch Research Institute : Introduction to CR

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