2. Slide Title
.DEFINTION:
“A clinical trial is a research study
designed to test the safety and effectiveness of
new treatments for cancer. Every cancer-fighting
drug and therapy available to doctors today had
to be tested in a clinical trial before it could be
used routinely on patients.”
3. Phase1(20-80 volunteers)
• (Normal volunteers)
• (several months)
• The test is designed to determine
• 1.whether there occur a difference in
pharmacokinetic response to drug in humans and
animals
• 2.the maximum tolerated dose and safety of the
drugs i.e., the therapeutic dose of the drug
• 3.the different pharmacodynamic parameters
• 4.To detect the adverse/toxic effect of the new
drugs
4. Phase II(20-300 volunteers
• (selected patient)
• (months to years)
• .To determine dose metabolism and kinetics of the new drugs.
• Phase II trials are conducted on large group of volunteers ranging
between 20-300. it is the first trials in which the drugs is studied in
patient with specific target disease
• This phase is mainly used to determine the therapeutic efficacy, safety,
ADRs, final dose rang and dosage form. it is further divided into early and
late phase
5. • 1.Early phase
• This phase is mainly designed to determine the dosage requirement. The
number of volunteers selected for this purpose vary form 20-200. the trials
design followed is signals blind, where the volunteers is unaware whether
he is being given a placebo or a standard drugs(control) or the
investigational new drugs. Therapeutic uses and side effects of the drugs
are explored in this phase.
• 2 late phase
• It is designed to study the efficacy of a drug for which 50-300 volunteers
are selected. Doubles blind design is followed in the late phase
6. Phase III(300-3000 volunteers)
• (large numbers of selected patients)
• (1-5 years)
• To determine safety and efficacy of the new drug and reduce the
errors of phase I and phase II trials.
• These trials are usually expensive, time-consuming and difficult to
conduct. Therapeutic value of the drug is confirmed in this phase. It
also provides information about additional safety,
• Adverse effects, drugs interactions and pharmacokinetics of the
new drug.
7. The trial design used here is Randomized controlled multicenter
trial and double-blind cross-over design.
1.Randomization
Initially, the volunteers are divided in two different groups by
randomization method. The investigational drugs is
administered to one group while the other groups receives a
standard drugs and the results are compared.
8. • 2 Double- blind cross-over design
• A Cross- over design is the one in which the
volunteers is initially administered the investigational
new drug. After a wash-out period i.e. 7 days,
standard drugs is administered. Thus, in this design
the volunteers acts as his own control, thereby
reducing any individual variations.
9. • In this design the investiganal
drugs, placebo and standard drugs
are administered alternatively each
treatment lasting for nearly
• 7days with an interval of one week
to allow time for the medicine to
get washed out. In this way each
and every volunteer receives all
the three treatments.
week Grou
p1
Grou
p2
Grou
p3
week
1
stand
ard
place
bo
New
drugs
week
2
place
bo
New
drugs
stand
ard
week
3
New
drugs
Stand
ard
drugs
place
bo
10. • These trials are generally conducted by physicians/
clinicals at clinical centers.
• This process usually takes nearly five years to complete.
once the results are obtained,
• Simple statistics like student t-test and chi-square tests
are performed.
• The other difficult statistics like analysis of variance,
covariance, non-parametric are also done.
11. • Phase III is completion,
• New drug application(NDA) is filed and sumitted to the
concerned authorities for licensing.
• This applications includes all the details about the
investigational drug,
• The monograph of the product, results of trials, trial process,
the proposed name of the product, its packaging details etc.
• Once this application is accepted and is in compliance with
the regulations, the authorities give permission to release the
drug into market.
12. • phaseIV(patient given drug therapy)
• To determineADRs of new marketed drugs
• phaseIV clinical trials are knowns as post-marketing
surveillance trials.
• After the approval of the new drug for marketing,
phaseIV trials begin. It is also known as post licensing
period.
• In this trials, data about the efficacy and adverse effects
are collected form the practising physicians.
13. • These trials are performed on large number of patients and for a
long time, during which rare and long term adverse effects,
unexpected drug interactions, unexpected clinical uses of the drug
can be discovered.
• This phase has no fixed duration.
• If any harmful or life threatening effect are noticed during this
course the drug is restricted form being sold in the market.
• Example; cerivastatin(anti hyperli
• pidemic) marketed under trade names Baycol and lipobay, has
been removed form the markets as it caused sever muscle
degeneration.
