Clinical Research In India

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 (Human Pharmocology Trials)

Maximum Tolerated Several dose Months Safety of an IP Pharmocokinetics and Pharmocodynamic Data are examined

20-80

Phase II (Expolratory Trials)

Therapeutic uses Few 100-300 Effective dose ranges Months to Several years

Phase III (Confirmatory Trials)

Evidence about safety 1-4 years 1000-5000 and efficay of the drug Comparison with Standard drug or Pacebo

Phase VI (Post Marketing Surveillance)

Assesment of Therapeutic values and safety New 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

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

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 f)

Regulatory approval from the DCGI in parallel with Ethics Committee approval. Regulatory & IRB approval process: India PI submits

CDA signed, Site Selected, Release Protocol

Consent Letter from PIs

application to EC reply to queries

Queries from EC

Contract executed All documents received

Approvals from EC

Approvals from EC to PI

Regulatory dossier compilation

Internal review of dossier

Regulatory submission to DCGI

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.

Regulatory Approval from DCGI

Export Licence Obtained from DGFT

DGFT Export Licence Application

Submission to DGFT

Clinical study start approval time in India is 12 weeks. - Typical Timelines for Regulatory Approvals Regulatory body

Approval

Time

Drugs Controller General of India (DCGI)

Regulatory approval for study 10 weeks - mean conduct in India

Ethics Committees

Ethics committee approval by 4 - 6 weeks (in parallel) the various study sites

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 Permission to export blood Trade (DGFT) samples outside India

Additional 2 – 4 weeks

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

India IndiaVS VSWestern Western countries countries  Patient enrollment  Diversity  Genetic uniqueness  Co • English competency

India India VS China VS China  Diversity  Genetic uniqueness  English competency  Medical infrastructure  Familiarity with western

+

 Medical infrastructure  Western medicine familiarity  Companies with international

medicine  Costs  Patient enrollment

=

standards  IPR reputation  Industry standards  Less established infrastructure

-

 Foreign partnerships  Resources  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 Success Drivers

Indian clinical research industry estimated at over US$ 100 mn

Cost Advantage Fast Rate of Subject Recruitments Improved Medical Infrastructure Large Pool of English Speaking Investigators

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.

Increasing Compliance with ICH –GCP Patient Diversity

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

Opportunities in India for Clinical Development

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Treatment naïve Caucasian patients with diseases of both the tropical and industrialised world

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   

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New Delhi

High incidence of cancer Type II Diabetes, lipid disorders and obesity widely prevalent Infectious Diseases Mumbai

Motivated English speaking investigators Urban centric cost effective health care system Robust IT infrastructure & resources Stable Regulatory Environment

Bangalore Chennai

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Thank You

Presented By Harshad K More