2. WHAT IS CLINICAL TRAIL?
Clinicaltrail are the trails in which safety and
tolerance limit of the drug is evaluated in to
the animal or in the human being
3. Why the clinical trails necessary
Clinical trails are necessary for decreasing
the mortality rate of the human due to
unexpected toxicity of the newer molecule
It has been told that if we omit the phase of
the clinical trails than the total population of
the world will be half of the current population
4. How to get permission for CT
Data of safety needs to be submitted
Protocol need to submitted
Strategy and planning need to submit
5. Various phases of CT
Preclinical
trail ( in animal)
Phase 1 (on healthy human volunteers)
Phase 2 (on patient)
Phase 3 (on patients and special population
also)
Phase 4 (Post marketing surveillances)
7. Preclinical trails
Studies carried out at preclinical trail phase
Development of the methodology for quantification of
drug in plasma
Mass balance-metabolite profile
PK monitoring
PK-PD relation
Long term toxicity
Protein binding
Tissue distribution
Placental transfer kinetic
8. Phase 1 trail
On the healthy 10-20 healthy volunteers
First time dealing with human
9. Phase 1 trail
Objectives
Determine the tolerability and acute toxicity
Characterize PK (single and multiple dose)
Dose-concentration-effect or toxicity relation
To check Suitability of animal model
Evaluate bioavailability
10. Phase 1 trail
Types of study
Dose- concentration-effect or toxicity relationship
(checking for linearity )
IV single-dose study
Radio active tracer study for study mass balance
Evaluation of suitability of animal model
Evaluation of drug formulation
Effect of food
Special population
11. Phase 2
First
time we introduce drug to pateint
Normally 100-200 patients are taken for trail
Conducted in OPEN manner
12. Phase 2
Objectives
For define most effective dose
Collect the additional safety and PK data
To check the difference in PK and PD in
healthy volunteers and patient
Careful monitoring more than one
therapeutic or toxicity end point
13. Phase 3
Comparatively longer time require than
phase 2
Normally up to 1000 volunteers are taken for
conducting trail
14. Phase 3
Objectives
To identify less common side effect
Comparison with standard therapy
Study in special population
Long term safety
Long term effectiveness
Study different dosage regimen
Closer inspection of the drug interaction
For developing the drug with multiindication
15. Phase 4
No specific planning
5000-10,000 patient are taken for trail
Some rare problems may came out
16. Drug labeling
To advice the prescriber regarding the safe
and effective use o the drug
To individualized the drug therapy
Gives information to clinician for choosing
the correct dose for individual patient