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
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Epoch Research Institute India Pvt. Ltd
Epoch Research Institute India Pvt. Ltd
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