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 information you can drop your mails on info@epoch.co.in #clinicalsasprogramming #clinicalsas #sastraining #clinicalsasprogrammer #hadoop #bigdata

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.
1. Surveillance
2. Answer FDA inquiries
3. Cost effective analyses versus other treatments
4. 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
ConMeds
Exposure AE
MedHist
Disposition
Findings
ECGPhysExam
Labs
Vitals Subj Char*
Subst Use*
Incl Excl*
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.