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Learn Clinical SAS Programming : Epoch Research Institute

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Clinical SAS This bootcamp training program will not only cover detail about data manipulation, generation of tables and graphs but it also make you industry ready with clinical research theory and case studies based on phase trials. This program also help candidate in preparation of SAS Certified Clinical SAS Programmer credentials. Participants get one complimentary attempt for Base SAS and Advanced SAS Certification Exams. Participants needs to complete 7 days project as part of their bootcamp. The project includes following topics Learn how to • Clinical trials process • Accessing, managing, and transforming clinical trials data • Statistical procedures and macro programming • Reporting clinical trials results • Validating clinical trial data reporting. For More Details mail on info@epoch.co.in – PowerPoint PPT presentation

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Title: Learn Clinical SAS Programming : Epoch Research Institute


1
Application of SAS in Clinical Trials
  • Epoch Research Institute India Pvt. Ltd


2
Agenda
  • About Clinical Trial
  • Clinical Trial Data
  • Role of SAS in Clinical Trial
  • Clinical SAS Work Process
  • SAS Life Science Industry Framework

3
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.

4
Not precisely.!!!
5
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.

6
Clinical Trial in Nutshell
7
Phases of Clinical Trial
  • Clinical Trail is Basically divided in to Four
    Phases
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

8
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

9
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.

10
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.

11
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

12
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

13
Data of Clinical Trial
14
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
15
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

16
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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