An OverviewAn 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(Human Pharmocology Trials)

Maximum Tolerated doseSafety of an IPPharmocokinetics and Pharmocodynamic Data are examined

Several Months 20-80

Phase II (Expolratory Trials)

Therapeutic usesEffective dose ranges

Few Months to Several years

100-300

Phase III(Confirmatory Trials)

Evidence about safety and efficay of the drugComparison with Standard drug or Pacebo

1-4 years

1000-5000

Phase VI(Post Marketing Surveillance)

Assesment of Therapeutic values and safetyNew indication , New method or New administration

Patient Population

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

Valuable process to ensure high quality data!

Clinical Trial Process

Processes in Clinical Trial

Ethics in clinical researchEthics 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 Principlesa) Principle of Essentialityb) Principle of Voluntariness, Informed Consent and

Community agreementc) Principle of Non- Explotationd) Principle of Privacy and Confidentiality e) Principle of Precaution and Risk Minimisationf) Principle of Proffesional Competenceg) Principle of Accontability and Tranperancyh) Principle of the Maximisation of the Public Interest

and of distributive Justicei) Principle of Institutional Arrangementj) Principle of Public Domaink) Principle of Totality of Responsibility l) Principle of Compliance

Contract executedAll documentsreceived

Regulatory dossier

compilation

CDA signed,Site Selected,

Release ProtocolConsent Letter

from PIs

Internal reviewof dossier

PI submits application

to ECreply to queries

Approvals from EC

Regulatory submission

to DCGI

Queriesfrom EC

Approvals from EC

to PI

Regulatory Approval

from DCGI

DGFTExport Licence

Application

Submission to DGFT

Regulatory approval from the DCGI in parallel with Ethics Committee approval.

Export Licence Obtained

from DGFT

Regulatory & IRB approval process: India

The DCGI (Drug Controller General of India) is responsible for the approval of manufacturing & marketing of new pharmaceutical products and the control & regulation of clinical trials for new drugs.DGFT is the Directorate General of Foreign Trade which provides permission for the export of patient samples.

Clinical study start approval time in India is 12 weeks.

12

Regulatory body Approval TimeDrugs Controller General of India (DCGI)

Regulatory approval for study conduct in India

10 weeks - mean

Ethics Committees Ethics committee approval by the various study sites

4 - 6 weeks (in parallel)

Drugs Controller General of India (DCGI)

Test license to import trial supplies

2 weeks

Total (parallel processing)

N.A. 12 weeks

Directorate General of Foreign Trade (DGFT)

Permission to export blood samples outside India

Additional 2 – 4 weeks

Genetic Engineering Approval Committee (GEAC)

Approvals for studies using r-DNA products

Additional 12 to 14 weeks.

- Typical Timelines for Regulatory Approvals -

- Regulatory Approval Timelines expected to further decrease. -

India VS Western countries India VS China

Patient enrollment Diversity Genetic uniqueness Co • English competency

Medical infrastructure Western medicine familiarity Companies with international

standards IPR reputation Industry standards Less established

infrastructure

Diversity Genetic uniqueness English competency Medical infrastructure Familiarity with western

medicine Costs Patient enrollment

Foreign partnerships Resources Patent regime

=+

-

India VS Western countries India VS China

Patient diversityPatient heterogeneityWorld class medical infrastructureFamiliarity with western medical facilitiesEnglish competencyCost competency ( patient recruitment, shorter timelines,manpower etc.,)ICH / GCP guidelines implementationProject management competenciesCentral lab facilities ( Internationally, nationally accredited)Regulatory guidelines and government policies – helping clinical in india ( MOH, DCGI, ICMR, DBT etc.,)

Indian clinical research industry estimated at over US$ 100

mn

Increasing compliance with ICH-GCP protocols

Growing body of trained and experienced investigators

India expected to capture about 10% of the global clinical

research market by 2010

Big Pharma contributing patients from India for multicentric

global trials for FDA/EMEA submissions.

7 of the Top 10 global CROs have a presence in India

Cost Advantage

Fast Rate of Subject Recruitments

Improved Medical Infrastructure

Large Pool of English Speaking Investigators

Increasing Compliance with ICH –GCP

Success Drivers

Clinical Research – India, most significant emerging geography

Patient Diversity

16

Opportunities in India for Clinical Development

Treatment naïve Caucasian patients with diseases of both the tropical and industrialised world High incidence of cancer Type II Diabetes, lipid disorders

and obesity widely prevalent Infectious Diseases

Motivated English speaking investigators

Urban centric cost effective health care system

Robust IT infrastructure & resources

Stable Regulatory Environment

Mumbai

New Delhi

Chennai

Bangalore

Thank YouThank You

Presented By

Harshad K More