An Overview

Defination of Clinical
Research
Clinical Research is a systematic study
for new Drug in human beings to
generate data for discovering or
verifying the Clinical, Pharmacological
or adverse effects with the objective of
determining safety and efficacy of the
new drug.
 Phases Purpose Length Subjects

Phase I Maximum Tolerated Several 20-80

(Human dose Months
Pharmocology Safety of an IP
Trials) Pharmocokinetics and
Pharmocodynamic Data
are examined

Phase II Therapeutic uses Few 100-300

(Expolratory Effective dose ranges Months to
Trials) Several
years

Phase III Evidence about safety 1-4 years 1000-5000

(Confirmatory and efficay of the drug
Trials) Comparison with
Standard drug or
Pacebo

Phase VI Assesment of Patient

(Post Marketing Therapeutic values and Population
Surveillance) safety
New indication , New
method or New
administration
Different types in Clinical Research

Global clinical trials – Phase I, II, III, IV

Data management, Biostatistics, report
writing Central bioanalytical lab facilities

Multicentric clinical trials

Clinical trial management
Clinical operations management
Clinical trial site management
Pk – PD / Bioavailability, Bioequivalence
studies
Clinical Trial Process

Valuable process to ensure high

quality data!
Processes in Clinical Trial
 Ethics in clinical research
Ethics refers to moral principles governing
human character and conduct.

The Principle of Respect for Persons (subjects) as

autonomous individuals whose welfare and rights need to
be respected.

The Principles of Beneficence (do good) and Non

Maleficence (do not harm) requires investigators to
minimize the harm and enhance benefits to the study
population.

The Principle of Justice requires priority to be given to

the interests of worst off even if the total welfare in society
is thereby dimished.
Ethical Principles
a) Principle of Essentiality
b) Principle of Voluntariness, Informed Consent and Community
agreement
c) Principle of Non- Explotation
d) Principle of Privacy and Confidentiality
e) Principle of Precaution and Risk Minimisation
f) Principle of Proffesional Competence
g) Principle of Accontability and Tranperancy
h) Principle of the Maximisation of the Public Interest and of
distributive Justice
i) Principle of Institutional Arrangement
j) Principle of Public Domain
k) Principle of Totality of Responsibility
l) Principle of Compliance
Regulatory approval from the DCGI in
parallel with Ethics Committee
approval.
Regulatory & IRB approval
process: India PI submits
CDA signed,
Consent Letter application Queries Approvals
Site Selected,
from PIs to EC from EC from EC
Release Protocol
reply to queries

Contract Approvals
executed from EC
All to PI
documents
received

Regulatory Regulatory Regulatory DGFT

Internal review
dossier submission Approval Export Licence
of dossier
compilation to DCGI from DCGI Application

The DCGI (Drug Controller General of India) is responsible

for the approval of manufacturing & marketing of new
pharmaceutical products and the control & regulation of Export Licence
Submission
clinical trials for new drugs. Obtained
to DGFT
DGFT is the Directorate General of Foreign Trade which from DGFT
provides permission for the export of patient samples.
Clinical study start approval time in India
is 12 weeks.
- Typical Timelines for Regulatory
Approvals -
Regulatory body Approval Time

Drugs Controller General of Regulatory approval for study 10 weeks - mean

India (DCGI) conduct in India

Ethics Committees Ethics committee approval by 4 - 6 weeks (in parallel)

the various study sites
Drugs Controller General of Test license to import trial 2 weeks
India (DCGI) supplies

Total (parallel processing) N.A. 12 weeks

Directorate General of Foreign Permission to export blood Additional 2 – 4 weeks

Trade (DGFT) samples outside India

Genetic Engineering Approval Approvals for studies using r- Additional 12 to 14 weeks.

Committee (GEAC) DNA products
- Regulatory Approval Timelines expected to further
decrease. -
12
 IndiaVS
India VSWestern
Western India India
VS China
countries VS China
countries
 Diversity
 Patient enrollment

+
 Genetic uniqueness
 Diversity
 English competency
 Genetic uniqueness
 Medical infrastructure
 Co • English competency
 Familiarity with western
medicine
 Medical infrastructure

=
 Costs
 Western medicine familiarity
 Patient enrollment
 Companies with international
standards
 IPR reputation

-
 Foreign partnerships
 Industry standards
 Resources
 Less established infrastructure
 Patent regime
Patient diversity
Patient heterogeneity
World class medical infrastructure
Familiarity with western medical facilities
English competency
Cost competency ( patient recruitment, shorter
timelines,
manpower etc.,)
ICH / GCP guidelines implementation
Project management competencies
Central lab facilities ( Internationally, nationally
accredited)
Regulatory guidelines and government policies –
helping clinical in india ( MOH, DCGI, ICMR, DBT
Clinical Research – India, most significant emerging
geography
Indian clinical research industry estimated at over US$ 100
Success Drivers
mn

Cost Advantage
Increasing compliance with ICH-GCP protocols
Fast Rate of Subject
Growing body of trained and experienced investigators
Recruitments
India expected to capture about 10% of the global clinical
Improved Medical
Infrastructure research market by 2010

Large Pool of English Big Pharma contributing patients from India for multicentric
Speaking Investigators
global trials for FDA/EMEA submissions.
Increasing Compliance
with ICH –GCP 7 of the Top 10 global CROs have a presence in India

Patient Diversity
Opportunities in India for Clinical
Development
 Treatment naïve Caucasian
patients with diseases of both
the tropical and industrialised New Delhi
world
 High incidence of cancer
 Type II Diabetes, lipid disorders
and obesity widely prevalent
 Infectious Diseases Mumbai
 Motivated English speaking
investigators
 Urban centric cost effective Bangalore
health care system Chennai
 Robust IT infrastructure &
resources
 Stable Regulatory Environment 16
Thank You
Presented By

Harshad K More