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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.
2
CONTENTS
1. Introduction 4
3
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.
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.
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 .
<--Follow up stages-->
300%
250%
RECRUIMENT PERCENTAGE
<--Active Recruitment-->
200%
<--Close up stages-->
150%
100%
50%
0%
REGISTRY/CLINICAL TRIAL
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
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
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
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
RELAX
3 PHASE III 24/9/14 5 129 60% (3) 5 months -
ASIA
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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.
5
5
4
Frequency
2 2 2
2
1
1
0
Cross sectional Budget Impact Cohort Observational Clinical audit
Analysis
IIR Type
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.
7 8
6
Frequency
2
2
1
1
0
Workshop Conference Professional Certification
Activities
LEVEL TOPIC
Factors contributing to fall among adult inpatients at Hospital Queen Eliza-
Hospital Queen Elizabeth II
beth II. A Cross sectional study.
Exploring the cost of Heart failure in Hospital queen Elizabeth II, Kota Kinaba-
NHAM - CRM Kuala Lumpur
lu Sabah.
Economic Burden of Heart failure in Hospital Queen Elizabeth II, Kota Kina-
HTA Asia Link 2017Annual Conference Hanoi
balu Sabah.
Frusemide adjustment in Heart Failure during Ramadan: Effectiveness and
ESC Heart Failure, Paris
safety pilot study
30th Sabah State Pharmacy Conference 2017 Knowledge and Awareness of patient toward unused medication: An investi-
& 5th Sabah Research Day 2017 gator guided survey in Sabah.
30th Sabah State Pharmacy Conference 2017 Knowledge and Competency among community pharmacist in Sabah: A stim-
& 5th Sabah Research Day 2017 ulated patient study.
Exploring the cost of stage C Heart Failure in Hospital Queen Elizabeth II Kota
5th Sabah Research Day 2017
Kinabalu.
Understanding the factors associated with self-care behaviour among Heart
11th NCCR 2017
Failure patients.
Clinical characteristic and survival rate of Advanced Heart Failure palliative
11th NCCR 2017
patient at Sabah Heart Centre
Table 6. List of papers presented at various conferences.
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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.
30
25
frequency (n)
20
15
12
10
6
5
0
NMRR PRESENTATION PUBLICATION
Submission category
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 !!
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
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
Group Picture with CRC staff, State Health Director, YBMK, Clinician &
Hospital Director
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