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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 inpatients. • 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* Subst Use* MedHist PhysExam ECG 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.