This Presentation contains an introduction to clinical research. * Basic definition of Clinical Research. * Steps involved in clinical Research. * Phases in Clinical Research. * Types of clinical Trials.

1. INTRODUCTION TO
CLINICAL RESEARCH
By-World of Pharmacy

2. CLINICAL RESEARCH
CLINICAL RESEARCH
Treatment of
Patients
Systematic
investigation &
study

3. • Clinical research is a branch of medical science which deals with the study of
safety and effectiveness of medications, devices, diagnostic products and
treatment regimens intended for human use.
• Clinical research involves the study of the clinical efficacy of materials and
methods that play a significant role in the prevention and cure of various health

4. Drug
discovery
Clinical Trial
Phase 4
FDA Review
NDA
submission
DCGI
Approval
Phase 1
Phase 2
Phase 3
7 Steps in Clinical Research

5. PHASE 0
1-Human micro dosing studies.
2-1/100th of human dose is given ; less than
100mcg.
3-Identify target.
4-done for special diseases.
5-dilute drugs in nano particles.
PHASE 1
1-Human Pharmacology.
2-20to 50 healthy volunteers.
3-P.o-Safety
4-S.o-Pharmacokinetics,dynamcis,tolerability.
5-months to 1.5 years.
6-MTD-maximum tolerated dose is calculated.
PHASES IN CLINICAL RESEARCH

6. PHASE 3
1-Therapeutic confirmatory Trails.
2-1000 to 2000 larger number of patients.
3-P.o-Safety.
4-S.o-Effectiveness confirm.
5-1 years to 4 years.
PHASE 4
1-Post marketing
studies/surveillance.
2-Marketed world wide.
3-P.-Safety and to check effects.
4-2 years.
1-Therapeutic exploratory trails.
2-100 to 500 individual with target
disease.
3-P.o-Safety
4-S.o-Effectiveness testing.
5-Months- 2 years.
PHASE 2

7. TYPES OF CLINICAL TRIALS
Observational Trials Interventional Trails
A study in which researcher observed
individual and record the information
about the individuals.
A study in which researcher
performed experiments and the
subject receives some kind of
interventions such as new drugs.

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