to know ...

Objective is......

WHATare clinical trials?

I have discovered a drug and my object is

to market it to

make...

$money$

FDA

But

wont let you do it

But... Why...?

because FDA is not sure whether your drug is

SAFE &EFFECTIV

E

But how do I convince FDA thatmy drug is ...

...SAFE & EFFECTIVE ?

By bringing evidencethroughCLINICAL TRIALS!

But wait!First you have to doPRE clinicalTrials!

before human testing is permitted

i.e. Testing on animals

To know if this drug is relatively safe to be tested

in humans

For this acute, sub acute and

chronic toxicities are

studied

to know probable therapeutic action....

What?

Where?

to know pharmacokinetics

What happens to drug in the bodyand how?

It takes about two yearsOn averege......gives data on

SafetyToxicityPharmacodynamicsPharmacoknetics

But Congratulations now you can file for

Now is the time to start Clinical Trials...

General Process followed in clinical trial

Phase 1

bring the humanvolunteersnow... about the size of ...

this class room

i.e. 30-50 approx

healthy volunteers!

Collect data on

dose response relationshipsafe dosage rangeacute effects over rangeside effects

Phase 2

done on patients

hundreds of people

approx 100-300

Question is...Whether the PATIENT has the desired therapeutic effects at

doses that are tolerated by sickpatients?

Single blinded or double blindedcontrolled study

Phase 3

In about1000-5000

people

Question is...Whether the drug works in the

manner proposed for its ULTIMATE GENERAL USE?

Explore

further beneficial actions

toxicities

compare with older therapies

With all this info on NDA FDA evaluate

a drug and takes decision on approval

Phase 4

Used by masses

POST MARKETING SURVEILLANCE

Market it for the masses to be used as prescription drug

and then watch closely

to prevent major therapeutic disasters/

find outinfrequent side effects.

It takes about 8 to10 years on averege but finally

Patent for20 years