Transcript Dr. Narges Mahaluxmivala - IGMORIS

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INDIA
Opportunities and Experiences in
conducting Clinical Trials in India
Narges Mahaluxmivala
MD (Bom), DTM&H (Eng)
Quintiles India
September 25, 2003
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Clinical Research in India
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Knowledge-based ‘service’ sector
Enormous potential for growth (size,
scale, range of services)
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to Indian and overseas research
organisations
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Benefits to India
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Boosts exports
earn foreign
exchange
Expands/enhances medical and
research infrastructure
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Major Enablers - 1
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‘Socio-economic changes’
 Increasing urbanisation
 Better education
 Higher incomes
 Better access to healthcare
 Increasing life span (aging population)
 Change in disease patterns
Changing attitudes
Changing demands
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Major Enablers - 2
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Need for new medicines
Availability of trained manpower
Well-equipped tertiary care hospitals
Large patient population
Usage of English for medical and
scientific communication
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Healthcare Industry
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Rs.100,000 crores growing at 17%
employing 60 lakhs people directly and
20 lakhs indirectly
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Development Research
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Opportunities
First Wave
 Phase III – IV Clinical Studies to international
standards
 Well equipped hospitals and qualified investigators
 English speaking population
 No-fault connectivity
 Data Management / Statistics
 Trained manpower
 Accredited laboratories
 Preclinical support services
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Development Research
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Opportunities
Second Wave - overlapping
 Phase I Clinical Studies to international norms
 Bioinformatics
 Health economics-related (health insurance liberalization)
IT-related back office services to development research
 RDE
eDC
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Development Research
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Opportunities
Third Wave - overlapping
 Genomics
 Tailored medicine research
 Diagnostics (new generation)
 Clinical trial management systems
 eDC (web-based)
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India
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Inherent Advantages
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Scientific Manpower
Scientific Knowledge
Global Exposure
IT development
Globalization of Trade
To evolve
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Business in a ‘patients’ regime
Healthcare delivery improvement
Greater industry/academia collaborations
Regulatory framework harmonization with global requirements
Resources – Manpower/Monetary/Material
Inexperience
Experience
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Today’s Realities
80
70
70
60
50
40
N o . o f S t udie s
30
30
20
10
0
19 8 0 s
120000
100000
12
80000
10
60000
40000
15
14
100000
No. of Pages
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19 9 0 s
R&D
Development
Cycles
8.1
8
38000
6
4
20000
2
0
0
1970s
1990s
1960s
1990s
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Dollars in Million m
Drug Development Costs
1000
900
800
700
600
500
400
300
200
100
0
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880
500
359
231
125
54
1976
1986 1986 1990 1995
(In current dollars)
2002
Source: R Hassen, PhD, University of Rochester; SN Wiggins, PhD, Texas A&M University, JA
DiM asi, Tufts University; Office of Technology Assessment, Boston Consulting Group.
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Drug Discovery accelerating
more drugs in the pipeline
1996 1997 1998 2002 Why ?
2853
3102
3278
5387
drugs
drugs
drugs
drugs
in
in
in
in
development
development
development
development !!!
High throughput screening
Molecular modeling
Genomics
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Growing Realization
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 The Cost of Pharma Research has to decrease
internal
external
- efficiencies
- outsourcing
More R & D will be done outside the USA & Europe
- cost
- enrollment
- time-to-market
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Clinical Trials
Sponsor Requirements
Investigator - required medical expertise
- interest in research discipline
Subjects - adequate numbers
- willing to comply with protocol
- treatment - naïve
Health-related infrastructure - well-equipped hospitals
- accessible and accredited
laboratory facilities and other
diagnostic facilities
- efficient courier system
- availability and familiarity with IT tools
- connectivity (RDE, IVRS,
telephonic patient diary reporting)
Disease Patterns - varied
- of developing and industrialised worlds
India Capability ?
YES
lower cost and
shorter recruitment time
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Contradictions in Clinical Research
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Clinical Trials are global
but
Controls are local
Clinical research is part of a ‘knowledge industry’
but
responses to it are ‘emotional’
Clinical research is based on science
but
influenced by political/cultural sensitivities and economic
backgrounds
Clinical trials are ‘experiments’
but
may be viewed as therapeutic options
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Interpretation / Implementation
of GCP
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Scientific Influences - minimal
Cultural Influences - significant
Acclimatization – slow
Complete cultural integration not the answer
but
differences to be appreciated
and accepted by both parties
Evolving standards of performance
 Drive the drug development process forward
 Prevent exploitation of the subject / patient
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Clinical Trial aspects affected by culture
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Ethical Review
Consent procedures
Standards of Care for control groups
Intervention offered or not after trial ends?
Placebo controls - yes or no?
Is the trial considered a treatment option?
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Ethical Review
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Medical Ethics in General
vs
Ethics within a protocol
(Risk/benefit analysis)
Perception of Risks and Priorities e.g. confidentiality
Absence of continuous oversight
Clinician vs investigator
(conflict of roles)
ECs need to make special efforts to understand and
comply with international standards
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Subject Consent
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Differing Doctor / Patient Relationship ?
Differences in understanding of studyrelated factors by subjects ?
Procedure meaningful or routine ?
Consent after discussions with family /
others
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Managing Relationships - 1
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Investigator
Clinical
Sponsor
Trial
Regulatory
Differing scientific and societal compulsions
Role of Monitor - very important
Cooperation / Coordination / Cross-cultural Communication
Researchers - culturally knowledgeable
- culturally sensitive
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Managing Relationships - 2
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Use of IT
IT Strategy for Investigator-facing activities
e.g.
databases
integrated tools
 IT - great equaliser
records and processes information as
programmed
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“Innovation opportunities occur when new
technologies and a fresh perspective converge”
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Conclusions
India is well placed to provide solutions for
contemporary and future clinical research
 Can facilitate affordable drug research
 Has required patient populations and quality scientists
and clinicians
 Has the information technology competitive advantage
 Has a regulatory framework which is moving towards
regulatory harmonization
 The socio-economic transformation in urban India
understands contemporary GCP requirements
 Rapid urbanisation and exposure to developed world
facilitates cross-cultural understanding
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