Learn Clinical SAS Programming : Epoch Research Institute

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Application of SAS in Clinical Trials

• Epoch Research Institute India Pvt. Ltd
• 
  

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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

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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.

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Not precisely.!!!
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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.

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Clinical Trial in Nutshell
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Phases of Clinical Trial

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

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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

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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.

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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.

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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.
• Surveillance
• Answer FDA inquiries
• Cost effective analyses versus other treatments
• Validation studies for rating scales

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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

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Data of Clinical Trial
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Data of Clinical Trial

Interventions
Events
Findings
Exposure
AE
Labs
Incl Excl
ConMeds
Disposition
Vitals
Subj Char
MedHist
ECG
PhysExam
Subst Use
QS, MB
CP, DV
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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

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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.

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