Q. Explain Various Phases Of Clinical Trials And Experimental Design Used In Clinical Trials ?
ANS :-
These Are Those Research studies in which we test a medicinal drugs , surgical or other medical events on a human.
The Main Aim of clinical trials is to determine the new treatment , drugs or medical devices are safe and effective for people or not.
• Clinical Trials Are Classified As Follow :-
• Phase 1 ( Human Pharmacology )
These Studies Are Conducted About 20-100 Healthy Volunteers.
It Take The 6-10 Months.
They Also Study drug pharmacodynamic and pharmacokinetics.
Finalize range of dose.
Maximum tolerabity and safety.
Clinical trials is the first time the new treatment is tested in people.
• Phase 2 :- Therapeutics exploratory trials .
100-500 diseased volunteers .
It takes 6 months to 3 years.
Clinical trials continue testing the safety and effectiveness of the new treatment.
Rec
Phase - 2 trials recruit and closely monitor the larger group of people.
Monitoring the side effect.
Evaluation of safety.
Minimum + maximum dose range.
• Phase 3 :- Therapeutics confirmatary trials.
Diseaseed volunteers is about 1000-5000.
Costly + longest trial .
Minimum 2 - 4.5 years.
Check safety , efficasy , tolaribity.
Clinical trials focused on determining whether the new product is more effective than the current treatment opsation.
• Phase 4 :- Post marketing trials .
Phase 4 trials are new treatment that have been reviewed and approved by regulatory bodies and now available to the public.
Phase - 4 trial are continue monitoring the long term risk and benefits of the newly approved treatment.
• Experimental Design :-
Experimental research design is used too study the effect of set of factors on the response of variable of system and it is based on scientific methods wherein casual relationship are studied under controlled conditions.
Experimental research is called laboratory experiment.
The experimental design consist of two types of groups :-
1) control group
2) experimental group
Some other terms are also important these are as follows :-
1) experimental treatment
2) test units
3) extraneous variables
4) randomisation of sample
5) factors
6) levels
Experimental design is the basic framework or structure of an experimental pn which the whole reserch work is focused.
These are two broad classification of experimental design such as :-
1) Informal Experimental Design
2) Formal Experimental Design
1) Informal Experimental Design :-
Informal experimental design are those design
A normally use a less sophisticated form of analysis
Based on differences in magnitudes.
These experimental design are classified as before and after without control design , after only with control design before and after with control design .
Before and after without control design aset of single test group is selected and the dependent variable is measured price to application of a specific treatment.
2) Formal Experimental Design :-
Formal Experimental Design offer Relatively more Control and use precise statical procedure for analysis.
Formal experimental design are classified as follow :-
1) completely randomized design
2) randomized block
3)latin square
4)factorial design
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