FIRST FOOTSTEP IN CLINICAL RESEARCH!!

1. Overview of Clinical Trial
Mr. Prosun De
M.Sc in Human Physiology

2. What is Clinical Trial?
• By the term ‘Clinical’ refers to some aspects of human research.
• Any Investigation in human subjects intended to discover or verify the
clinical, pharmacological & pharmacodynamic effects of an IP
(Investigational Product) or to identify any Adverse Reaction to an IP or
A-D-M-E of an IP to detect it’s SAFETY & EFFICACY.

3. INITIATIONof Clinical Trial
Clinical Trial
Pre
clinica/Non-
clinical Testing
(Animal
Experiment)
Drug
Discovery and
Development

4. Drug Discovery and Development
Pre-
Discovery
•Target Identification
•Target Validation
Drug-
Discovery
•Optimizing the ‘Lead-Compound’
Early Safety
Test
•Assessment of Safety and Efficacy of the molecule
•PK-PD parameters

5. Pre-Clinical/ non-clinical testing
• Lab & Animal Testing is usually to determine if the drug is safe enough
for human trial or human experiment.
• The purpose of this Phase are-
 Pharmacologic Activity
 Pharmacologic Response
 Absorption, Distribution, Metabolism & Elimination trials (A-D-M-E) trials
 Mutagenicity, genotoxicity and Teratogenicity

6. Flow-Chart of Clinical Trial

7. Submitting an ‘ind’ application
• Before a Clinical Trial begins (and after the Pre-clinical Testing),
Sponsor is required to submit an application to conduct study using
an IND (Investigational New Drug) Application to the FDA (Food and
Drug Administration).
• As a part of IND, Sponsor completes the form FDA 1571, which
declares their intent to conduct the trial on humans.

8. Different Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help
scientists answer different questions:
 In Phase I trials, researchers test a new drug or treatment in a small group of healthy people ( 20 -50)
for the first time to evaluate its safety, determine a safe dosage range. This phase is also known as MTD
(Maximum Tolerance Dose Determination Phase).
 In Phase II trials, the study drug or treatment is given to a selected group of patients (100 – 300) to see
if it is effective and to further evaluate its safety. This phase is also known as Therapeutic Exploratory
Trials.
 In Phase III trials, the study drug or treatment is given to a large group of patients ( 1000 – 3000) to
confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect
information that will allow the drug or treatment to be used safely. This phase is also known as
Therapeutic Confirmatory Trials.
 **In Phase IV trials, post marketing studies delineate additional information including the drug’s risks,
benefits and optimal use. This phase is also known as Post Marketing Surveillance.

9. Submitting an ‘ndA’ application
• After getting the Positive results from phase 3 of Clinical Trials
Sponsor has to filed an application to FDA, that is NDA (New Drug
Application).
• If Sponsor gets the approval from FDA then they can proceed for
Phase 4 Trials (Post Marketing Surveillance)