This document provides an overview of clinical research and the clinical trial process. It discusses the various phases of clinical trials from phase 1 to phase 4. Phase 1 trials assess safety in a small group of participants, while phase 2 trials provide preliminary efficacy and safety data in patients. Phase 3 trials further evaluate efficacy and monitor safety in a larger group of patients. Phase 4 trials collect additional safety and efficacy data after marketing approval. The document outlines the objectives and requirements of each phase of clinical trials and the overall goal of generating evidence about new treatments to improve human health.

1. Prepared by:
Harshada R. khandewal
B.Pharm 6th semister
Prepared by:
Anil Keshav Pawar
B.Pharm 6th semister

2. INDEX:
 Definition
 Introduction
 Types
 Steps involved in clinical research
 Clinical trials
 Phases of clinical trials
 Conclusion
 Participants requirements and participation.

3.  Clinical research:
clinical research is a branch if healthcare science that determines safety and effectiveness
od medication devices, diagnostic products and treatment regimens intended for human use.
Introduction:
 The maim purpose of clinical research is to generate new knowledge for improving health of
individuals and population.
 The result of clinical research should be provided information about prevention and treatment of
disease that can used for to improve health of human life.
 It involves human subject and can include broad spectrum of research for examples:
pharmacokinetics,clinical trial , safety epidemiological study and health services.

4. Type of clinical research
 The types of clinical research are as fallow;
1. Pharmacokinetics
2. Pharmacodynamic
3. Efficacy
4. Adverse effects
5. Interaction drug
6. Genomic
7. Pharmacoeconomics
8. Drug use studies
9. Quality of life
10. Stability
11. pharmacoepidimilogy

5. Steps in clinical research:
design excellent clinical research
researchers preparation
department review and approval
IRB review and action
conducting of research
Conducting reviews

6. CLINICAL TRIALS
 The clinical trials are experimental or observation done in clinical research.
 In which biomedical or behavioral research study on human include behavioral intervention,
new treatment and known internation study and comparison.
 Clinical trials generate data on safty and efficacy.

7.  It include following phase:
1. Phase 1
2. Phase 2
3. Phase 3
4. Phase 4
1. Phase 1 clinical trial
 Phase 1 clinical trials are the earliest in the life of a new drug or treatment.
 They are usually small trials, up to about 30 patients [healthy volunteers].
 These are often in patients in clinic, where the subject can be observed by “ full-time staff”.

8.  These trials are designed to obtained in following information
Safety:
 Determines most significant adverse effects in human subject.
Pharmacokinetics:
 How the drug molecules is absorbed in the body and its metabolised are distributed and eliminate from the
body.
Pharmacodynamic:
 The effect of drug on body i.e drug effects with the plasma concentration.

9.  Type of phase 1 trials:
a) SAD- single asending dose
b) MAD- multiple asending dose
c) FOOD EFFECT- effect of food substances on the absorption of drug.
PHASE 2:
 This is therapeutic exploratery trials.
 It involves 200 to 300 subject.
 To confirm, effectiveness monitor side effects and further evaluates safety.
 First in patients [who have specific disease-drug expected to treat].
 Duration- 6 months to several years.

10.  Objective:
 Efficacy in patients [primary objective]
 Safety issue[secondary objectives]
 Optimum dise finding:
1. Dose efficacy relationship
2. Therapeutic dose regiman
3. Duration of therapy
4. Frequency in administration
5. Therapeutic Windows
 Reviews of phase 1 data:
 Inovator/ expert
 IRB
 DCGi
For new action of a marketed drug start with phase 2.

11.  Phase 2 type:
1. Phase 2 A: designed to acess dosing requirements.
2. Phase 2 B: designed to study efficacy.
PHASE 3:
 Therapeutic confirmaory trials.
 Large scale, multicentre , randomised,controlled trials.
 Target population: several 100s to 3000 patients.
 Take a long time:up to 5 years
 To establish efficacy of drug against existing therapy in larger number of patients, method of
usage and to collect safety data etc…
Objective:
 To access overal and relatives therapeutic Value of new drug efficacy, safety and special
properties.

12.  To determine optimal dosage schedule for use in general.
 The dosage schedule in C.T.S should be as close as possible to its anticipated clinical use.
Prerequisite:
 Efficacy and dose schedule defined in phase 2 studies.
 No gross ADRs
 Long term pre clinical safty studies completed.
 chronic toxicity
 Reproductive toxicity
 Carcinogenicit
 IRB and DCGI approval obtained.
 Subtype:
1. Phase 3A: to get sufficient and significant data.
2. Phase 3B: allows patients to continue the treatment label expansion additional safety data.

13.  It also known “label expansion” to show the drug work for additional type of patients, disease beyond the
original use for which the drug was approved for marketing.
NDA- NEW DRUG APPLICATIONS
 Its is referred as new drug application.
 Formal proposal for the FDA/ DCGI established:
 drug is safe and effective
 Benefit outweigj the risk
 Proposed labelling its appropriate
 NDA can be thousands of pages long
 NDA contain all of the information gather during preclinical to phase 3.
 Can take 2-3 gear for FDA to reviews.

14. Phase 4:
 Done after drug has been marketed.
 No fixed duration/ patients population.
 Studies continue to collect data about effect in various populations and side effects from long term use.
 These new primary observations or non experimental in nature.
 Study:
 help to detect rare ADRs, drug interactions
 Harmful effects disorders may result in drug being no parger sold or restricted to certain use.
 Objective:
 Confirm efficacy and safety profiles in large population during practice.
 Detect the unknown rare adverse drug reaction.
 Evaluation of over dosage.

15.  Identification of new indication.
 Dose requirement: evaluation of new drug formulations, dosage, duration of treatment.
 Evaluation in different age group type of patients.
 Comparative benefits- risk assessment.
 CONCLUSION;
 Clinical trials is a human experiment designed to study the efficacy and safty of a new drug.
 It involves phase 1-4 with specific objectives and end results.
 Application to regulatory affair.
 IND: permission to conduct clinical trials.
 NDA: permissionto market new drug
 Clinical trials must fallow guidelines and protocol to ensure well being of participants.

16.  Participants requirements and participation:
 phase 0 and phase 1 drug trials seek healthy voluntres.
 Most other clinical trials patients who have a specific disease or medical conditions.
 All volunteers being considered for a trials are required to undrtake medical screening.
 Laboratory test:
1. Measurement of electrical activities of heart ( ECG).
2. Blood pressure, heart rate and body temperature.
3. Blood samples
4. Urine sampling
5. Weight and height measurement
6. Drug abuse testing
7. Pregnancy testing

17. THANK YOU!