Introduction to clinical research

When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.

This presentation will provide a basic overview of clinical research process.

1. Introduction to Clinical Research - I By Benhur Pradeep [email protected] http://www.myclinicalresearchbook.blogspot.com/

2. Outline Definition of Clinical Research & Clinical Trial Importance of Research Different types of Clinical Trials Different Phases of Clinical Trials Players in Clinical Trials Overview of Clinical Trial Summary

3. Clinical Research Branch of Medical Science. Systematic, observational and experimental biomedical studies. Ultimate goal is to improve the Quality of Life ( QoL ).

4. Clinical Trial One form of Clinical research Systematic experimental Biomedical studies. To evaluate the effectiveness and safety of medications or medical devices or biologics etc.,.

5. Three important keywords Experimental Unit Treatment Evaluation

6. Importance of Research New techniques for screening and diagnosing a disease. New drugs to market. New methods for surgery. New approach for radiation therapy. New combination of standard treatments. New techniques, such as Gene therapy.

7. Types of Clinical Trials Based on researchers behave Observational study Interventional study Based on the purpose Prevention trials Screening trials Diagnostic trials Treatment trials Quality of Life Compassionate use trials

8. Phases of Clinical Trial

9. Phase 0 Also called Human Micro-dosing studies. Gathers preliminary data Pharmacodynamics and Pharmacokinetics. Gives no data on safety or efficacy. Small number of subjects (10-15).

10. Phase I First stage of testing in human subjects (20-100) . Designed to assess the safety, tolerability, PK and PD of drug. Dose ranging – Dose escalation. Kinds of Phase I SAD MAD Food effect

11. Phase II Therapeutic Exploratory Trial. (20-300 Subjects). Efficacy in patients (primary objective) Safety issues (secondary objective) Optimum dose finding Phase II Phase IIA: Designed to assess dosing requirements Phases IIB: Designed to study efficacy

12. Phase III Therapeutic confirmatory trials. (300-3000 subjects). To establish efficacy of the drug against existing therapy in larger number of patients, method of usage etc.,. Subtypes Phase IIIA: to get sufficient and significant data. Phase IIIB: allows patients to continue the treatment, Label expansion, additional safety data.

13. Phase IV Post Marketing Studies (PMS). Involves safety surveillance. Determine behavior of drug in real life situations. Evaluate action of drug in a situation of missed dosage or over dosage.

14. Players in Clinical Trial Regulator Sponsor CRO Regulatory Personnel CRA Project Manager Medical Director Investigator/Sub-Investigator CRA Subjects IRB

15. Overview of Clinical Trial Study Design Design Study Documents Notification to Regulatory Authority Investigator Selection Ethics Committee Review Approval Letter Investigator Meeting Site Initiation Patient Enrollment Monitoring Data Management Follow up Visits End of Trial Statistical Review Final Report

16. What Happens During the Clinical Trial Depends on the kind of trial being conducted. Includes Doctors (Investigators), nurses, health care professionals etc., Monitors the participants carefully during the trial and stay in touch after the trial is completed. CT, successful when the protocol is carefully followed. Some trials involves interviews, questionnaires or surveys of interventional treatment.

17. Summary Clinical Research involves processes through which the testing article is tested for its effectiveness and safety for human use. Ensures complete safety of volunteers. Highly monitored and regulated.

18. Thank You http://www.myclinicalresearchbook.blogspot.com/