Industry-Sponsored Trials Who is Getting the Benefits?

Goh Tse Seng Clinical Operations Quintiles Malaysia Sdn Bhd

Copyright 2013 Quintiles

Worldwide, Next Door

The worlds largest CRO

Quintiles Offices Quintiles Central and Affiliated Labs

A Comprehensive Range of Services

Clinical Development
> Planning and Design > Phase I-IV > Central Labs > Cardiac Safety
> Integrated Site & Patient Services > Deep Therapeutic Expertise

FSP Outsourced Services

> Clinical monitoring > Data management > Pharmacovigilance > Biostatistics > Medical writing

Real-world & Late Phase Development

> Interventional IIIb/IV > Observational studies / safety surveillance > Patient Registries

Advisory Services
> Consulting > Capital investment > Scientific advisory boards > CRA training

Regulatory Services
> Regulatory submissions > Regulatory consulting > IND preparation

> Real-world research

Benefits of Integrated Services > Lower overall study costs > Better site support > Reduced timelines > Simplified trial management

Global Therapeutic Experience

This chart represents studies conducted from 2000-2010.

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Quintiles Malaysia Clinical experience

Quintiles Malaysia Clinical Experience
30 25 1600 1400 1200

Therapeutic Area CARDIOVASCULAR ENDOCRINOLOGY GASTROINTESTINAL HEMOG/ONC/TRANSPL ANTATION INFECTIOUS DISEASE NEUROLOGY OPHTHALMOLOGY PSYCHIATRY RESPIRATORY RHEUMATOLOGY WOMENS HEALTH/SEXUAL HEALTH NO DATA AVAILABLE TOTAL

# of Studies 14 15 6 11 24 8 1 16 8 14

Total Patients Randomized 495 909 66 94 1414 143 6 291 445 253

# of studies

20 15 10 5

Total Initiated Sites 54 104 25 36 56 24 2 63 36 59

# of patients

1000 800 600 400 200

2 2 121

11 2 4129

6 3 468

# of Studies

Total Patients Randomized

Source: Quintiles Investigator Performance Database 2.4 report on 27 May 2013. Contains studies conducted from 1998 to present.

Total of 122 studies with 4129

patients and 66 unique sites

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Who is Getting the Benefits?

Who are Getting the Benefits?

Sponsor

General Population

Investigator

Patients

Institution

Country

Investigators View: Why Conduct Industry-Sponsored Trials?

Investigators View: Why Conduct Industry-Sponsored Trials?

<1% of all physicians ever participate in sponsored trials

Source: Clinical Trial Magnifier Vol. 3:6 Dec 2010

Benefits to Investigator

Training Education
Practical Experience

Advancement of scientific knowledge

Investigator

A change from routine work

10

Benefits to Investigator

Scientific leadership / Professional standing

Administrative assistance

Sense of altruistic

Financial gain
(support in-house IIT)

Investigator

11

Benefits to Institution
An established clinical research infrastructure / facilities
Skillful investigators and site staff Institutional track records and reputation Revenue

12

Benefits to Country

Global recognition of its researchers expertise

Accelerated / Improved policies by regulatory authority

Income

Job opportunities

13

Benefits to Patients

Early access to new treatment

Renewed hope
Better patient care

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Benefits to Patients

15

THANK YOU!

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