2017

ANNUAL REPORT
Clinical Research Centre
Queen Elizabeth II Hospital II
 CLINICAL RESEARCH CENTRE
HOSPITAL QUEEN ELIZABETH II

CRC VISION
To promote, support and conduct clinical research in Sabah.

MISSION
To improve patient’s outcome through quality and ethical clinical re-
search conducted by trained and skilled healthcare workers in research.

CRC HQE II MISSION (2017-2020)

 Sabah Heart Centre Research & Development

 Service based Research (QEH– Clinical Services)
 Quality & Governance
 Human Resource Development
 Collaborative Research & Development
 Clinical & Health Information
 Pharmaco/Health Economics

2
 CONTENTS

No Title Page number

1. Introduction 4

Industrial Sponsored Research (ISR) statistic

2. 5-9
report

Investigator Initiated research (IIR) statistic 10

CRC Achievements report

CRC Training/ Activities 11

CRC submission year end statistic report 12

3. CRC Staff 13-14

4. CRC’s in photo 15-16

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 CLINICAL RESEARCH CENTRE
HOSPITAL QUEEN ELIZABETH II
Clinical Research Centre (CRC) Queen Elizabeth Hospital II (QEH II) was
established in December 2011 as part of Ministry of Health (MOH) CRC Network. It is
headed by Dr.Liew Houng Bang with the aim to promote, support and conduct qual-
ity and ethical clinical research to improve patient outcome.

CRC was formed with the aim of enhancing clinical research activities on hospitals by creating
atmosphere as well as providing facilities to support research activities at Ministry of Health facility.CRC HQE II
undertakes clinical research (ISR & IIR), provides research-related administrative services and conduct training
courses annually.
Besides undertaking clinical research, CRC QEH II also provides research-related administra-
tive services and training such as research methodology, medical biostatistics and Good Clinical Practice (GCP)
workshop. CRC and Cardiology Department QEH II work closely in view of both sharing same Head of Depart-
ment, this also cultivate research culture among clinicians. CRC HQE II accepts staff of various background. The
team consists of medical officers, pharmacist, research nurse, research officers, CRM study coordinators and
administrative assistant.
The year 2017 is a remarkable year for the CRC HQE II as we are the organizer for 5th Sabah
Research Day that took place on 13-14 September. The theme for Sabah Research Day was “Strengthen Re-
search Capacity, Leave your Legacy” and we receive many research presentation submission from Tawau, San-
dakan and Keningau districts.

We even had guests

from Hospital Melaka and Insti-
tute Kanser Negara. In conjunc-
tion with the research day, we in-
vited the health minister YB Datuk
Seri Dr S Subramaniam to grace
this occasion by officiating the
opening of our CRC.

Pic 1 : YBMK Cutting Ribbon to officiate CRC accompanied by Dr.Liew HB (Head of CRC),
Datuk Dr. Christina Rudin ( State Health Director) , HQE II Director & Other VIPs.

We are located at level 5, beside Cardiology Clinic QEH II.

Our contact is as below:
Clinical Research Centre,
Level 5 (adjacent to Cardiology Clinic),
Hospital Queen Elizabeth II
Jalan Bersatu Off Luyang,
88300 Kota Kinabalu, Sabah.

Phone no : 088-324600 ext 2019 ; Fax no : 088-237553

Email : crcenquiry@gmail.com
Quick scan on this QR code to
our eCRC portal. 4
INDUSTRIAL SPONSORED RESEARCH (ISR)
In year 2017, CRC QEH II was involved in 18 Industrial Sponsored Research (ISR), 9 study is Phase III
clinical trial, 7 registries and 2 observational study. Out of 18 studies, 7 of these are still in patient re-
cruitment stage, 5 studies in close up stage and the remaining 6 studies involved active telephone/
clinical visit follow up.

TYPES OF INDUSTRIAL SPONSORED RESEARCH IN CRC QEH II

10
9
9

8
7
7
Number of Study (n)

3
2
2

0
PHASE III REGISTRY OBSERVATIONAL

Studies Type

Figure 1 shows The type of Industrial Sponsored Research is conducted at CRC HQE II in 2017

5
INDUSTRIAL SPONSORED RESEARCH (ISR)

In year 2017, most of our ISR’s have achieved 100 % recruitment rate before recruitment closure
date. Registry studies have achieved yearly target and remaining are in follow up/close up stages .

RECRUIMENT ACHIEVEMENT (%) FOR ISR UPDATED 2017

350%

<--Follow up stages-->
300%

250%
RECRUIMENT PERCENTAGE

<--Active Recruitment-->
200%
<--Close up stages-->
150%

100%

50%

0%

REGISTRY/CLINICAL TRIAL

INDUSTRIAL SPONSORED RESEARCH (CRC HQE II)

Figure 2 Summarized the ISR, its recruitment status and achievement .

6
 INDUSTRIAL SPONSORED RESEARCH (ISR)
Table 1 and 2 highlight the important data of all ISR’s conducted in CRC QEH2. CRC and cardiology de-
partment staff worked closely to screen and recruit subjects for all the studies that we are committed to. For
most of the studies, we aimed to keep our first-patient-in (FPI) date less than 4 months after site initiation
visit. We are always motivated by our head of CRC department, to achieve at least 80% recruitment for all of
our studies.
TIME
PATIENT ACHIEVEMENT
TARGET TAKEN
SITE SCREENED TILL DECEM-
NUMBER DURATION TO
NO STUDY TYPES INITIATION (TILL 31ST BER 2016(%)
OF SIV TO FPI REACH
VISIT DECEMBER (NUMBER OF
SUBJECTS 80%
2017) PATIENTS)
TARGET

31
1 ASIAN HF OBSERVATIONAL 19 Nov 12 175 1000 95% (170) 4 days
months

2 COMMANDER PHASE III 15 Jul 15 5 358 60% (3) 3 months -

3 VICTORIA PHASE III 25 Oct 16 15 155 20% (3) 3 months -

2
4 ODYSSEY PHASE III 17 Jul 13 10 87 100% (10) 2weeks
months

10
5 REDUCE PHASE III 7 Oct 14 50 98 196%(98) 2 days
months

1
6 MIRAGE PHASE III 22 Jul 14 8 13 100 %(8) 1 day
month

7 LIMUS DEB PHASE III 15 Dec 15 10 33 30% (3) 9 months -

MORPHEUS
8 REGISTRY 5 Sept 17 30 - 17% (5) 15 days -
BIOMMIME

-
TARGET
9 REGISTRY 16 July 17 150 - 33.3% (50) 10 days
FIREHAWK

-
PASSWORD
10 REGISTRY 20 Sept 17 50 - 4% (2) 23 days
REGISTRY

-
COROFLEX
11 REGISTRY 20 Sept 17 50 - 4% (2) 15 days
ISAR NEO

Globally
12 STENTYS REGISTRY 4 Nov 15 3000 - (60) 1 day -

DES - 12
13 REGISTRY 30 Oct 13 20 58 290% (58) 7 months
COROFLEX months

Table 1. List of ISR with on going recruitment in 2017. 7

INDUSTRIAL SPONSORED RESEARCH (ISR)
Five ISR’s were completed in 2017 and ready for study closure. Big applause for MASCOT study because
we have exceeded the sponsor’s expectation and achieved 102% recruitment.

ACHIEVEMENT
PATIENT
TARGET TILL
SITE SCREENED TIME TAKEN
NUMBER DECEMBER DURATION
NO STUDY TYPES INITIATION (TILL 31ST TO REACH
OF 2016(%) SIV TO FPI
VISIT DECEMBER 80% TARGET
SUBJECTS (NUMBER OF
2017)
PATIENTS)

PAN ASIA
1 OBSERVATIONAL 28/9/16 50 55 72%(36) 5 days -
BOD

2 FOURIER PHASE III 12/6/13 10 212 10 %(1) 17 months -

RELAX
3 PHASE III 24/9/14 5 129 60% (3) 5 months -
ASIA

4 SONAR PHASE III 18/8/16 10 29 20% (2) 2 month -

5 MASCOT REGISTRY 6/11/14 50 56 102% (51) 20 days 11 months

Table 2. List of ISR completing in end of 2017.

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 In October 2017, we received our first ISR inspection from regulatory board National
Pharmaceutical Control Bureau (NPRA) were inspected on ODYSSEY study ( A Randomized, Double Blind,
Placebo –Controlled, Parallel-group study to Evaluate the Effect of Alirocumab on the Occurrence of Cardio-
vascular Events in patient who have recently Experienced an Acute Coronary Syndrome). The inspection
lasted for 5 days and these are the key findings:
1. Conduct research activity without MREC approval.
2. Initiation of study procedure/activity prior to completion of informed consent process.
3. Procedures were not performed as prescribed in the currently approved protocol.
4. Administrative non compliance issues such as data discrepancies between e Case Report Form (eCRF)
and source document.
There were a total of 16 major and minor deviations according to inspection report. The study team has gained
tremendous insight from the inspectors and learnt from our past mistakes in conducting clinical trial. This
inspection has also led us develop a comprehensive checklist for ISR internal audit

Group Photo with ODYSSEY Clinical Research Associates (CRA) & National Pharmaceutical Regulatory Bureau (NPRA) 9
Inspectors.
INVESTIGATOR-INITIATED RESEARCH (IIR)
Investigator Initiated Research (IIR) is KPI for all staff in CRC department. Since CRC & Cardiology
Department are under the leadership of Dr.Liew HB cardiology medical officers and pharmacists are encour-
aged to conduct researches and submit abstracts to relevant conferences. Besides medical officers and phar-
macists, CRC aims to bring staff nurses on board to conduct nursing-based clinical research.

TYPE OF INVESTIGATOR INITIATED RESEARCH (IIR) STUDY AT HQE II

6

5
5

4
Frequency

2 2 2
2

1
1

0
Cross sectional Budget Impact Cohort Observational Clinical audit
Analysis
IIR Type

Figure 3. List of IIRs in collaboration with CRC

No FIELD TOPIC
1. Cross sectional Understanding the factors associated with self care behaviour among heart failure patients
2. Cross sectional Utilization of Ministry of Health medication return programme, knowledge and disposal
practice of unused medication in Malaysia
3. Cross sectional Knowledge & Competency among community pharmacist in Sabah : A stimulated patient
study
4. Cross sectional Factors contributing to fall among adult patients at HQE II : A cross sectional study
5. Cross sectional FERCAP - National IIR
6. Cross sectional Evaluating patient satisfaction in Emergency & Trauma Department of HQE II
7. Cohort TB event outcomes and compliance fixed dose therapy (FDC) when compared to separated
dose formula (SDF) in Pulmonary Tuberculosis patient : An analysis of TB database using
propensity score matching technique
8. Cohort Frusemide adjustment in Heart failure during Ramadan : Effectiveness and safety pilot study
9. Cohort To Evaluate and validate the same TT2R score in atrial fibrillation patient to predict the good
anticoagulant control with warfarin in good time therapeutic range setting centre
10. Clinical Audit Audit on Heart Failure Management
11. Budget Impact Analysis Budget Impact Analysis of Fibrinolytic Prescription for STEMI
12. Budget Impact Analysis Budget Impact Analysis of platelet function test amongst patients with ACS and/or PCI at
HQE II
Table 3 Types of IIRs in Hospital Queen Elizabeth II in 2017.

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 CRC TRAINING/ACTIVITIES
CRC organized a variety of activities for healthcare professionals who are interested in conducting
own research. We conducted workshops to cultivate the research passion among healthcare professionals and
provides trainings for researchers who lack research skills. On the other hand, CRC support healthcare profes-
sional to various national/regional conferences for poster/oral presentation to gain exposure and learn from the
experienced. Conferences also served as platform for researchers to socialize, communicate, exchange ideas
and learn from each other.

ACTIVITIES SUPPORTED BY CRC HQE II

7 8
6
Frequency

2
2
1
1
0
Workshop Conference Professional Certification
Activities

Figure 4 . Activities supported by CRC QEH2 in 2017 and its frequency.

ACTIVITIES TITLE NO OF PARTICIPANTS

Professional Good Clinical Practice Workshop 40
Workshop Introduction to Clinical Research 28
Evidence Based Workshop 25
Basic Research Methodology 24
Qualitative Workshop 16
Basic SPSS Workshop Level 1 18
Sabah Research Camp 10
Scientific Writing Workshop 10
Budget Impact Analysis Workshop 14
Conference National Conference for Clinical Research (NCCR) 10
Sabah Research Day 128
Table 4 . Activities supported by CRC QEH2 in 2017
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 CRC SUBMISSION

No Published Paper title Authors

1 Randomized Comparison of Absorb Bioresorable Vascular Scaffold and Mirage Microfiber Dr. Liew Houng Bang &
Sirolimus Eluting Scaffold using Multimodality Imaging Collaborations
2 Dr. Liew Houng Bang ,
Cost of Elective percutaneous coronary intervention in Malaysia : A multicentre cross sec-
Dr. Liau Siow Yen &
tional costing study
Collaborations
3 9 Month result of Polymer free Sirolimus eluting stents in young patients compared to a
Dr. Liew Houng Bang &
septuagenarian and octogenarian all comer population, Journal of Interventional Cardiol-
Collaborations
ogy
4 Multinational and multi ethnic variations in health- related quality of life in patients with Dr. Liew Houng Bang &
Chronic Heart failure – American Heart Journal Collaborations
5 Comparison of the treatment practice and hospitalization cost of percutaneous coronary
Dr. Liew Houng Bang &
intervention between a teaching hospital and general hospital in Malaysia : a cross sec-
Collaborations
tional study
6 Dr. Liew Houng Bang ,
Insights from a rheumatic Heart Disease Registry in a Tertiary Centre in Sabah Dr. Liau Siow Yen &
Collaborations

Table 5 . CRC Publications for the year 2017

LEVEL
Hospital Queen Elizabeth II
NHAM - CRM Kuala Lumpur
HTA Asia Link 2017Annual Conference Hanoi
ESC Heart Failure, Paris
30th Sabah State Pharmacy Conference 2017
& 5th Sabah Research Day 2017
30th Sabah State Pharmacy Conference 2017
& 5th Sabah Research Day 2017
5th Sabah Research Day 2017
11th NCCR 2017
11th NCCR 2017
Table 6. List of papers presented at various conferences.
TOPIC
Factors contributing to fall among adult inpatients at Hospital Queen Eliza-
beth II. A Cross sectional study.
Exploring the cost of Heart failure in Hospital queen Elizabeth II, Kota Kinaba-
lu Sabah.
Economic Burden of Heart failure in Hospital Queen Elizabeth II, Kota Kina-
balu Sabah.
Frusemide adjustment in Heart Failure during Ramadan: Effectiveness and
safety pilot study
Knowledge and Awareness of patient toward unused medication: An investi-
gator guided survey in Sabah.
Knowledge and Competency among community pharmacist in Sabah: A stim-
ulated patient study.
Exploring the cost of stage C Heart Failure in Hospital Queen Elizabeth II Kota
Kinabalu.
Understanding the factors associated with self-care behaviour among Heart
Failure patients.
Clinical characteristic and survival rate of Advanced Heart Failure palliative
patient at Sabah Heart Centre

12
 CRC SUBMISSION
CRC provides NMRR submission advice to researchers during research consultation clinic. In order to expose
our young researchers with presentation experiences, CRC encourages poster and oral presentations in major
conferences in related field. We ended this fruitful year by having 6 publications from CRC HOD Dr. Liew HB (6) &
former CRC deputy Dr. Liau SY (2) in high impact peer reviewed journals. Not only that , this year 12 presentations
were made in regional/national conferences.

CRC HQE II SUBMISSION

40
35
35

30

25
frequency (n)

20

15
12
10
6
5

0
NMRR PRESENTATION PUBLICATION
Submission category

Figure 5. CRC submission year 2017.

16
NMRR SUBMISSION 2017
14
14 13
Number of submission (n)

12
10
8
6
4 3 3
2 1 1
0

Department
13
Figure 6. NMRR submission according to department.
NEW TEAM MEMBERS IN
CRC
Grazele Jenarun (BSc. Food Science and Nutrition) joined CRC HQE II as a Research Officer
since April 2017. She was introduced to the field of research since her undergraduate years and has
shown her great interest in doing research especially in matters related to public health science and
nutrition. As an avid learner, she continues to develop her skills and knowledge as a researcher, striving
to excel in this arena. She also a yoga practitioner and hiking junkie !!

Indoituwo Binti Kawaru (Staff Nurse) has been in service with

the government for 33 years. She has experience as an infection control
nurse for fourteen years in Hospital Lahad Datu. For the past two years,
she played an important role as state infection control coordinator in JKNS
under Infection Control Unit. She’s a very dedicated staff and she hopes
with the experiences that she has, she can serve CRC for a better future.

Dr. Teoh Eu Vin (MBBS) has joined CRC as a medical officer since May 2017 after completing
his housemanship training in Johor Bahru. He has had prior exposure to clinical research in 2015 from
a part-time stint at CRC Hospital Sultanah Aminah Johor Bahru, and decided to gain further exposure
in clinical research after his housemanship training.

Vimala Veni joined CRC as research nurse in early July 2017. She
has been in service with the government for 9 years. She has experience as
Cardiac Care Nurse for 7 years. She has had prior exposure to clinical
research in 2014 from an Advanced Diploma in Cardiovascular Nursing,
Kuching. She decided to gain further exposure in clinical research by given
opportunity to be a part CRC team HQE II.

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 FAREWELL CRC

Farewell Lunch with Dr. Fathiyah Ahmad

SN Lilyiana Pengui
Farewell dinner with Dr. Liau Siow Yen (CRC HQE II Deputy Head) (CRC Admin manager)

CRC HQE II team wish all the best to Dr.Liau Siow Yen (Deputy Head CRC HQE II), SN Lilyiana Pengui
(Admin Manager) & Dr. Fathiyah Ahmad (Medical Officer) who has extended their career path to new place.
The team appreciates and thank them for their diligence and enthusiastic spirit throughout their service in
CRC. We believed they loved working on group projects with CRC team and enjoyed all CRC activities. Thank
you for the support, guidance, and encouragement they have provided us during in CRC.

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HQE II Cardiology MO’s
YBMK Officiate CRC

CRC OPENING
CEREMONY
BY YBMK
Dr.Liew Briefing poster board to YBMK &
DATO’DR. S. SUBRAMANIAM
Datuk Dr. Christina
ON 16TH SEPTEMBER 2017

HQE II Cardiology Nurses

Group Picture with CRC staff, State Health Director, YBMK, Clinician &
Hospital Director

YBMK signing the plague

CRC Staff welcoming YBMK

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 SABAH RESEARCH
DAY 2017

NCCR
Conference
2017

Research
Camp 2017

Training &
Workshop

SPSS
Workshop 17
 Please scan the QR code or go to stated URL to view CRC 2017 news-
letter. Thank you.

https://www.dropbox.com/sh/71jodmogtpym913/AABoEPoIKAwWmdAyZo4g_BhBa?dl=0 18