Professional Documents
Culture Documents
Tech Biotechnology IV
Year
Introduction to
Clinical Trials
Unit I
PowerPoint Lecture Slide Presentation prepared by
R. Saicharan, Assistant Professor, DBT, SNIST
Key words
Treament
Experimental unit
Evaluate
Experiment
Research
question
Data
Conlusion
and
ways
to
7
Copyright R. Saicharan, Assistant Professor, DBT, SNIST
History
Perhaps the first ever
clinical trial was James
Linds demonstration in
1753 that citrus fruits
cured
scurvy.
He
compared the effects of
various different acidic
substances ranging from
vinegar to cider, on
groups of sailors, and
found that the group who
were given oranges and
lemons
had
largely
recovered from scurvy
after 6 days.
Copyright R. Saicharan, Assistant Professor, DBT, SNIST
Lessons &
development
regulatory process
marketing
post registration
monitoring
First patent
application
Drug Discovery
Target and lead Lead
identification
optimisation
Clinical trial
application
10
11
12
13
14
15
Product licence
application
Drug Development
Development
Concept testing for launch
Clinical Development
Phase I Phase II Phase III
12-150
50-1000 500-5,000
people
people
people
Product life
Launch cycle support
1-8
1-3
16
Phase I trials
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-15000
people
Phase 2 trials
Phase I
50-150
people
50-1000 patients
Extensive monitoring
Safety and tolerability in patients
Often complicated design, explorative
Selection of optimal dose
Pharmacokinetics in patients
Effect in special populations
Explorative
Copyright R. Saicharan, Assistant Professor, DBT, SNIST
Phase 3 trials
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-15000
people
500-15000 patients
Effect is verified in the target population
Forms the basis of the NDA, New Drug
Application
Interactions between drugs start to become
measurable in the larger population
sub-groups start to be established
special features and problems show up
Confirmative
Copyright R. Saicharan, Assistant Professor, DBT, SNIST
Length Purpose
Phase
I
Phase
II
20
100
Up to
several
100
Phase
III
100s
several
1000
% Drugs
Successfully
Tested
NY/VI AETC
Phase IV trials
Phase I
50-150
people
Phase II
100-200
people
Phase III
500-5,000
people
Phase IV studies
continue
Observational studies
analysis
interpretation
time
now
analysis
now
interpretation
time
Cochrane Collaboration
http://www.cochrane.org/index.htm
Preparation of
statistical
analysis
Outline
Clinical Study
Protocol
Study
Setup
Study Conduct
Data Capture
Statistical Analysis
Clinical Study
Report
Publication
s