Clinical Trials: Trial Phases and design is a ppt on the different phases of the Clinical trials from Preclinical to Phase 4and the different trial designs that can be adapted to carry out the trial in humans. Preclinical phase is the phase in which trials are carried out in animals. On sucessful conduct of animal trials trials are continued in humans after filing an IND (Investigational New Drug application). The Phases in humans range from phase 1-4 besides which an additional phase called the phase 0 may be implemented in certain trials. The phase 0, also known as the microdosing phase reduces the entire duration of the trial. After Phase 3 of the trial an NDA (New Drug application) is filed to the regulatory authority, acceptance of which allows the drug to be released into the market. The phase 4 (Post Marketing surveillance) is the phase after the marketing of the drug which helps monitor adverse effects of the drug. Clinical trial dsigns are of different types based on intervention, randomisation and grouping. Few of which are case contol study, cohort study, cross sectional study and randomised contol trials. Randomised contol trials are of different types: Parallel design: Patients are assigned and treatment is administered to two groups simultaneously: one with the investigational drug and the other with a placebo. Crossover: Two groups are given two different treatments (A AND B) randomisation is on whether the group is given treatment A first or treatment B first, since both groups are given both the treatments. Latin square design: 4 different treatments are given (placebo or standard) to 4 groups. The treatment are given in such a way that each patient gets each treatment atleast once. Factorial design: 2 or more treatments are tested simultaneously such that treatment A vs control of treatment A and treatment B vs control of treatment B can be tested simultaneously.

1. CLINICAL TRIALS
TRIAL PHASES AND DESIGN
PRESENTED BY:
Padmini Dutta Hazarika
RCR 2557
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PHASES OF CLINICAL TRIAL

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Preclinical Research
IND Application
Phase IV
Submission of NDA
Phase III
Phase II
Phase I
Pharmacodynamic
studies in animals
Assess safety,
tolerability, PK and
PD of drug
Drug disease
interaction,
efficacy of drug
Evaluate
effectiveness and
risk- benefit ratio
Monitor long term
effects and
effectiveness
IND application requesting approval to begin
testing in humans
Formal proposal to approve new drug for sale.
In animal models
20 to 80
individuals
100-300
individuals
1000- 3000
individuals
1000+
individuals
3-6 years (3.5
approx)
1-2 years
1-2 years
2-3 years
Ongoing
following FDA
approval

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CASE CONTROL STUDY:
•Identification of subjects based on outcome status.
•Retrospective in nature.
•Comparison of frequency of exposure in a group having the disease with a group free
of the disease.

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COHORT STUDY:
•May be prospective or retrospective.
•Group of people with defined characteristics are followed up to determine
incidence of, or mortality from, some specific disease, all causes of death, or some
other outcome.

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CROSS SECTIONAL STUDY:
•To determine the prevalence without manipulating the study environment.
•Causal relationship not determined as subjects are not followed up.

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LONGITUDINAL STUDY:
•Similar to cross sectional study.
•Follow up carried for a longer duration and hence causal relation of condition
determined.
•Can be descriptive or analytical.
RANDOMISED CONTROL TRIAL:
•Participants are randomly allocated into group receiving control or treatment
drug.
•Reduces bias.

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Defined population
TREATMENT
NO
TREATMENT
Improved Not improved Improved Not improved
Parallel design graph

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Crossover design graph

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Latin Square design
Subjects
Study
Period 1
Study
Period 2
Study
period 3
Study
period 4
1 A B C D
2 B C D A
3 C D A B
4 D A B C
Washoutperiod
Washoutperiod
Washoutperiod

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Both A and B
B but not A
A but not B
Neither A nor B
TREATMENT B
+ -
TREATMENTA
+
-
Factorial design graph

13. THANK
YOU!
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