Clinical Research in India
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Transcript of Clinical Research in India
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