QUINTILESINDIA

Opportunities and Experiences in conducting Clinical Trials in

India

Narges MahaluxmivalaMD (Bom), DTM&H (Eng)

Quintiles India

September 25, 2003

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Clinical Research in India

Knowledge-based ‘service’ sector Enormous potential for growth

(size, scale, range of services) to Indian and overseas research

organisations

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QUINTILESINDIABenefits to India

Boosts exports earn foreign exchange

Expands/enhances medical and research infrastructure

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Major Enablers - 1

‘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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Need for new medicines Availability of trained manpower Well-equipped tertiary care hospitals Large patient population Usage of English for medical and

scientific communication

Major Enablers - 2

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Healthcare Industry

Rs.100,000 crores growing at 17%

employing 60 lakhs people directly

and 20 lakhs indirectly

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Development Research

OpportunitiesFirst 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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OpportunitiesSecond Wave - overlapping Phase I Clinical Studies to international norms Bioinformatics Health economics-related (health insurance

liberalization)

RDE eDC

Development Research

IT-related back office services to development research

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Development Research

OpportunitiesThird Wave - overlapping Genomics Tailored medicine research Diagnostics (new generation) Clinical trial management

systems eDC (web-based)

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QUINTILESINDIAIndia

Inherent Advantages Scientific Manpower Scientific Knowledge Global Exposure IT development Globalization of Trade

To evolve 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

30

70

0

10

20

30

40

50

60

70

80

1980s 1990s

No. of Studies

38000

100000

0

20000

40000

60000

80000

100000

120000

1970s 1990s

No. of Pages8.1

15

0

2

4

6

8

10

12

14

16

1960s 1990s

R&DDevelopmentCycles

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Drug Development Costs

54125

231

359

500

880

0100200300400500

600700800900

1000

1976 1986 1986 1990 1995 2002(In current dollars)

Do

llars

in M

illio

n m

Source: R Hassen, PhD, University of Rochester; SN Wiggins, PhD, Texas A&M University, J ADiMasi, Tufts University; Office of Technology Assessment, Boston Consulting Group.

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Drug Discovery accelerating

more drugs in the pipeline

1996 - 2853 drugs in development1997 - 3102 drugs in development1998 - 3278 drugs in development2002 - 5387 drugs in

development !!!Why ?

High throughput screening Molecular modelingGenomics

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Growing Realization

The Cost of Pharma Research has to decrease

internal

- efficiencies

external

- outsourcing

More R & D will be done outside the USA & Europe

- cost

- enrollment

- time-to-market

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Clinical Trials

Sponsor Requirements India Capability ?

Investigator - required medical expertise - interest in research disciplineSubjects - adequate numbers - willing to comply with protocol - treatment - naïveHealth-related infrastructure - well-equipped hospitals YES - accessible and accredited laboratory facilities and other lower cost and diagnostic facilities shorter recruitment time - efficient courier system - availability and familiarity with IT tools - connectivity (RDE, IVRS, telephonic patient diary reporting) Disease Patterns - varied - of developing and industrialised worlds

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Contradictions in Clinical Research

Clinical Trials are globalbut

Controls are local

Clinical research is part of a ‘knowledge industry’but

responses to it are ‘emotional’

Clinical research is based on sciencebut

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

Scientific Influences - minimal Cultural Influences - significant Acclimatization – slow

Complete cultural integration not the answerbut

differences to be appreciatedand accepted by both parties

Evolving standards of performance Drive the drug development process forward Prevent exploitation of the subject / patient

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QUINTILESINDIAClinical Trial aspects affected by

culture

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

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

Differing Doctor / Patient Relationship ? Differences in understanding of study-

related factors by subjects ? Procedure meaningful or routine ? Consent after discussions with family /

others

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Managing Relationships - 1

Differing scientific and societal compulsions

Role of Monitor - very important

Cooperation / Coordination / Cross-cultural Communication

Researchers - culturally knowledgeable - culturally sensitive

Investigator

Clinical

TrialSponsor Regulatory

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QUINTILESINDIAManaging Relationships

- 2

Use of IT IT Strategy for Investigator-facing activities

e.g. databases integrated tools

IT - great equaliserrecords and processes information as

programmed

“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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