Post on 04-Jun-2018
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Paving Industry Sponsored Research in Klinik Kesihatan
Dr Akhmal Yusof CEO Clinical Research Malaysia
Outline
• A brief history in time : • The Numbers
• The Therapeutic Area
• The Sites
• How ISR could help KK?
• Closing notes
KK involvement in ISR by State • KK starts to conduct ISR as early 2011
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2
4
6
8
10
12
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SelangorWP KL & PutrajayaPahang N Sembilan Kedah Perak Kelantan Penang Sabah Johor Sarawak
No KK involved in ISR by state (2014-2016)
1 2
4
2 1 1
2 1
1 2
3
1
1
7 10
9
12
1
1
2
1
1 2
1
1 1
2 2 2 2 2
3
5
6
10 11 11
13
0
2
4
6
8
10
12
14
No
. of
app
rove
d t
rial
s
States in Malaysia
No. of KK conducting ISR by State
2014 2015 2016 2017 Total
10
50
9
1 4
12
6
1 0
10
20
30
40
50
60
Yr 2014 Yr 2015 Yr 2016 Yr 2017
No
. of
app
rove
d t
rial
s
Year
No. of Approved ISR in KK (2014 – 2017 (Mar))
# Participating KK Sites # Approved Trials
Notes: 1. The same trial could be conducted at multiple sites. 2. 1 trial approved to be conducted at KK site (as of Mar 2017) i.e. KK Putrajaya involved in CQVM149B2303 trial (Respiratory)
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3
2 2 2 2
1 1 1
0
1
2
3
4
5
6
7
8
9
Endocrinology Epidemiology O & G Cardiology /Vascular disease
Respiratory Vaccine Gastroenterology Neurology Paediatrics
Therapeutic Area of Trials involving KK from 2014 -2016
No. of Approved Trials
The intangible value of ISR
TECHNOLOGY TRANSFER
DESIGN STUDY PROTOCOL
STUDY METHODOLOGY
DATA MANAGEMENT
EXPANDING RESOURCES
INCREASE TREATMENT
OPTIONS
PROVIDE RESOURCES TO
STUDY SITES
PROVIDE NEW KNOWLEDGE
GLOBAL RECOGNITION
CONSISTENT TIMELINE
RELIABILITY QUALITY
1. Where does Malaysia stands in ASEAN region conducting ISR?
A. Number 1
B. Number 2
C. Number 3
D. Number 4
Country Number of ISRs*
(2013 – 31/12/2016)
Thailand 741
Singapore 600
Malaysia 311
Philippines 207
Vietnam 154
Indonesia 111
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Source: ClinicalTrials.gov, 20th January2017 * Studies received from 01/01/2013 to 12/31/2016
Where does Malaysia stand in SEA (2013 – 2016)
Focus training to Investigators
CRM Roadshow Protocol Deviation Workshop
Hospital Pulau Pinang Roadshow
Hospital Ampang Roadshow
GCP Refresher
‘I am AWARE’ campaign aims to raise patient and public awareness in clinical trials by providing the necessary means for patients and public to get information on clinical trials or to participate in any ongoing trials.
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• Common diseases : Cardiovascular, Cancer, Diabetes
• Public Healthcare spending keep growing • An increase of 57% in the number of clinical trials
in less than 4 years. • Consistent timeline for Regulatory and IRB approval
• Population 31.7 million 0–14 years: 24.5% 15–64 years: 69.4% 65 years and over: 6%
Source: Department of Statistics, Malaysia, 2016
• Multiracial (English widely spoken and understood)
Malaysia Research Environment
5th January 2017, International Living in its Annual Global Retirement Index 2017 honoured Malaysia for the third consecutive year of being named the country with the “Best Healthcare in the World”
The ranking is based on: • the price of medical procedures • facilities available • excellent hospitals • highly trained doctors • affordable care
(source: www.internationalliving.com)
Malaysia is one of the Best Healthcare In The World
Poster Presentation
DIA Glasgow 29th March 2017 National Heart Association Meeting (NHAM), PP65, 8th April 2017
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0
5
10
15
20
25
30
35
40
45
2014 2015 2016
Growth of CROs 2014-2016
79%
15%
33
84
114
0
20
40
60
80
100
120
2014 2015 2016
Growth of Sponsors 2014-2016
154%
36%
Source: Malaysia’s Clinical Research Ecosystem, Applied Clinical Trials, Jan 26, 2017
• Making a Difference : NEW VALUE PROPOSITION
• Training & Development
• Recalibrate & Manage Performance
• Clearer Career Development
Building a Global Trusted Research Organisation
5 year Blue print
Clinical Research
Excellence and Advancement
Centre Malaysia (CREAM)
Sustainable Value
Proposition (SVP) Project
Project Accelerate
To manage own dedicated centre specializing on early phase development and oncology
To complete the Clinical/Scientific ecosystem and drive research that matters for Healthcare solutions
To create research training academy that is respectable in the SEA region
CRM 5 year strategies (2017 to 2020)
CRM provides global health solutions for the people through clinical research
Our deep understanding of the local clinical research landscape with the international standards of operations coupled with fundamental backing of the MoH provide us an incomparable advantage to deliver research and create high skilled job opportunities.
We believe…
…Thank you.