Clinical trials :-
Research studies aimed at evaluating a surgical or medical intervention efficacy in people
Used to evaluate whether a new drug,device is safe for human use
Scientists perform lab tests 1st on animals for testing efficacy & safety before FDA approves human test
Research studies aimed at evaluating a surgical or medical intervention efficacy in people
Used to evaluate whether a new drug,device is safe for human use
Scientists perform lab tests 1st on animals for testing efficacy & safety before FDA approves human test
Trials proceed through 4 phases to evaluate adequate doses,side effects
If after 3 phases FDA approves a drug intervention safe ,it gives approval for clinical use
Phase 1
New experimental drug,treatment
Small group of people 20 to 80
Test for dose safety,efficacy,side effects
If after 3 phases FDA approves a drug intervention safe ,it gives approval for clinical use
Phase 1
New experimental drug,treatment
Small group of people 20 to 80
Test for dose safety,efficacy,side effects
Phase 2
Larger group 100 to 300 people
Emphasis in phase 1 is on safety,phase 2 is on effectiveness
Evaluate whether a treatment,drug device works in a disease or medical condition
Look for safety,side effects
Last many years
Larger group 100 to 300 people
Emphasis in phase 1 is on safety,phase 2 is on effectiveness
Evaluate whether a treatment,drug device works in a disease or medical condition
Look for safety,side effects
Last many years
Phase 3
Further evaluation of safety,effectiveness across different populations,different doses,test in combination with other drugs
Number of people in phase 3 from few hundred to few thousand
If drug passes phase 3 FDA approves it for use in the population
Further evaluation of safety,effectiveness across different populations,different doses,test in combination with other drugs
Number of people in phase 3 from few hundred to few thousand
If drug passes phase 3 FDA approves it for use in the population
Phase 4
Drug has been approved for use in the wider population
Fda continues to monitor the safety, effectiveness in the larger population
Duration
Phase 1 - several months to years
Phase 2 - 2 to 3 years
Phase 3 - 1 to 4 years
@Coolfundoo
@thescorpionphil @unseenvalue
Drug has been approved for use in the wider population
Fda continues to monitor the safety, effectiveness in the larger population
Duration
Phase 1 - several months to years
Phase 2 - 2 to 3 years
Phase 3 - 1 to 4 years
@Coolfundoo
@thescorpionphil @unseenvalue
