Application of SAS in Clinical Trials

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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.

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 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. Surveillance2. Answer FDA inquiries3. Cost effective analyses versus other treatments4. 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

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

RecordedEntered 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.

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

SAS Life Science Industry Frame Work

SAS Initiatives in Life Sciences

• What are the most pressing technology issues facing life sciences?

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Better data integration

toolsDevelopment of data standards

Data storage and archiving

SAS® Industry Framework

SAS Industry FrameworkLife Sciences

SAS Industry FrameworkLife 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 CaptureCDMS: Clinical Data Management SystemCRO: Contract Research OrganizationLIMS: Laboratory Information Management System

Clinical Trial Data Mart Trial Reports – Control Group

Report , Affected Group ReportTrial MetricsTrial AnalysisCross – 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 Research Institute India Pvt. Ltd

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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.

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Epoch Research Institute India Pvt. Ltd

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