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The CRC Sabah Newsletter is a joint publication of the three CRC networks in
Sabah which comprise CRC HQE, CRC HQE 2, and CRC Likas. The newslet-
ter will update you with the activities organized by the CRCs, the upcoming
events, and the research updates.
In this issue, we are delighted to announce the upcoming inaugural Sabah
Medical Research and Scientific Conference 2013 that will take place in the
Postgraduate Medical Centre (PGMC), Queen Elizabeth Hospital, Kota Kina-
balu, Sabah on 18th and 19th October 2013. The highlight of the event is the
poster/oral competition which will be the platform to all healthcare profes-
sionals and students to share their research works with their peers. For those
who participate in this event, we would like to wish you the best of luck and
see you there soon!
WELCOME TO ISSUE 2 OF CRC
SABAH NEWSLETTER
CRCs Objectives are:
1.To promote a culture ofresearch among healthcareworkers in Sabah.
2.To disseminate skills inMethodology, Statisticaltools, and techniques indesigning and conducting
clinical trials.
3.To provide healthcareworkers the principle ofmethodology and biostatis-tics in clinical research.
CRC SABAH Issue 2
May - August 2013
CRCs Vision
To be a leading clinical research institution in Asia
CRCs Mission
To improve patients health outcomes through ethical and quality clinicalresearch
Inside this issue:
Page
Welcome to Issue 2 of CRCSabah Newsletter
1
Investigator Initiated Research
(IIR) and Industry Sponsored
Research (ISR) Updates
2
Activities and Photo Gallery 6
RCC Progress Report 8
Contact Us 10
Upcoming Events 10
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CRC Sabah NewsletterIssue 2 (May-Aug 2013)
No. NMRR ID Study Title Study Site1 NMRR-12-1183-14034
Sequence Variants of Putave Tumor Suppressor Genes in Nasopharyngeal
CarcinomaQEH
2 NMRR-12-1105-13079 Molecular Phylogenec Analysis of Malaria Parasite Plasmodium knowlesi JKNS
3
NMRR-13
-217
-15663
Research on Asian Psychotropic Prescripon Paerns for Andepressants
Follow up survey in 2013
HMBP
4 NMRR-12-1324-13746 Malaysian Acromegaly Registry QEH
5 NMRR-12-1175-13912The Funconal Improvement Aer Carpal Tunnel Release Using the Mini
Open Technique in Hospital Queen Elizabeth IIQEH 2
6 NMRR-13-196-15238Awareness and Atudes Towards HPV Vaccine and HPV-Related Diseases
Among HPV Vaccine Seekers in Keningau Hospital, SabahKeningau Hospital
7 NMRR-13-291-15704A Case Control Study on Environmental and Host-Related Factors Predis-
posing to Tuberculosis in Kota KinabaluQEH
8 NMRR-13-285-15720Clinical Presentaon of Leptospirosis. A Retrospecve Study of Paents
Admied to a Single Instuon Lahad Datu Hospital, SabahLahad Datu Hospital
9 NMRR-13-155-15167Are We Ready Ror the Early Discharge of People With Mental Illness Into
the Community?HMBP
10 NMRR-13-332-15632Development of Novel Biomarkers and Assessment of Health
-Related Qual-
ity of Life in Malaysian Paents With Nasopharyngeal CarcinomaQEH
11 NMRR-13-332-15632Development of Novel Biomarkers and Assessment of Health-Related Qual-
ity of Life in Malaysian Paents With Nasopharyngeal CarcinomaQEH
12 NMRR-12-1135-12252
A prospecve, Proof-of-concept Study to Evaluate High on-Clopidogrel
Platelet Reacvity and its Role in Determining Treatment Strategy,
Amongst Paents Presenng With Acute Coronary Syndromes or Undergo-
ing Percutaneous Coronary Intervenon
QEH 2
13 NMRR-13-241-15699Sokongan Sosial Kepada Pesakit Yang Menghidapi "terminal illness" dan
Mendapat Penjagaan Paliaf: Kajian Kes di Hospital Queen ElizabethQEH
14 NMRR-13-429-14814Deliberate Self-Poisoning and Self-Injury Cases in Duchess of Kent Hospital,
SandakanHDOK
15 NMRR-13-410-15337
An Evaluaon of Inial Vancomycin Dosing Based on Measured Serum
Trough Concentraon in Paediatric Paents in SWACH: A Retrospecve
Review
HWKKS
16 NMRR-13-404-15569
Inuence of Age, Gender, Ethnicity and Distance of Hospital From Home
Towards Time in Therapeucs Range (TTR) Among Warfarin MTAC Paents
in Hospital Tawau
Tawau Hospital
17 NMRR-13-234-15329Prevalence and Idencaon of Plasmodium knowlesi in Humans, Ma-
caques and Mosquitoes at Sabah, Malaysia
QEH / Tenom
Hospital
18 NMRR-13-308-14792
The Development and Tesng of a Model of Community Based Collabora-
ve Care for Paents With Severe and Enduring Mental Disorders in Malay-
sia: Phase 1.
HMBP
19 NMRR-13-590-15718 Database Registry of Children With Tuberous Sclerosis Complex HWKKS
20
NMRR-12
-1377
-14445
Muldisciplinary Approach in Improving Health Outcomes of Psoriasis Pa-
ents
QEH
21 NMRR-13-126-15119Prevenon of Post-ERCP Pancreas: A Randomized Clinical Trial using
Rectal DiclofenacQEH
22 NMRR-13-247-14802Validaon of the Malay version of the Strengths and Dicules Queson-
naire (SDQ) for the Malaysian PopulaonHMBP
23 NMRR-13-534-16348Kajian Kepenggunaan Portal MyHEALTH Dalam Kalangan Pesakit Hospital
Kementerian Kesihatan Malaysia 2013JKNS
24 NMRR-13-425-14815Substance Use Among Psychiatric npaents in Duchess of Kent Hospital,
SandakanHDOK
25 NMRR-13-354-16253 Amalan Gaya Hidup Sihat di Kalangan Paramedik Hospital Kuala Penyu Kuala Penyu Hospital
26 NMRR-13-546-16814Atude and Percepons of Healthcare Professionals towards Clinical Phar-
macy Services in Lahad Datu Hospital
Lahad Datu Hospital
Table 1: Investigator Initiated Research (IIR) approved by MREC
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CRC Sabah NewsletterIssue 2 (May-Aug 2013)
Table 2: Ongoing Industry Sponsored Research (ISR) in Sabah. May-Aug 2013.
No. NMRR_IDDepartment/
Unit
Site
InstuonResearch Title
Research
Subtype
1NMRR-10-
706-6055 Endocrine QEH I
A Phase III, mulcentre, internaonal, randomised,
parallel group, double blind cardiovascular safety
study of BI 10773 (10 mg and 25 mg administered
orally once daily) compared to usual care in type 2
diabetes mellitus paents with increased cardiovas-
cular risk.
Intervenonal
Study : ClinicalTrial
2NMRR-10-
628-5357Nephrology QEH I
Phase IIb/III Clinical Study Protocol
- Chronic Renal Failure (Primary Glomerular Dis-
ease/Nephrosclerosis) -
Intervenonal
Study : Clinical
Trial
3NMRR-12-
426-11014Rheumatology QEH I
A Phase 3b, Mulcenter, Open-Label Study to Evalu-
ate the Long-Term Safety and Ecacy of Subcutane-
ous LY2127399 in Paents with Systemic Lupus Ery-
thematosus (SLE) (ILLUMINATE-X)
Intervenonal
Study : Clinical
Trial
4 NMRR-
12-
1071-13841 Rheumatology QEH I
A Randomized, Double-Blind, Placebo-Controlled 52-
Week Study to Assess Adverse Events of Special
Interest in Adults with Acve, Autoanbody-
PosiveSystemic Lupus Erythematosus Receiving
Belimumab
Observaonal
Study : ClinicalEconomics
5NMRR-09-
401-4109Rheumatology QEH I
A Mulcenter, Randomized, Double-blind, Placebo-
controlled Trial of Golimumab, an An-TNF Mono-
clonal Anbody, Administered Intravenously, in
Subjects with Acve Rheumatoid Arthris Despite
Methotrexate Therapy
Intervenonal
Study : Clinical
Trial
6NMRR-10-
1193-5556Rheumatology QEH I
An observaonal study of Rheumatoid arthris pa-
ents on adalimumab to Evaluate quality of LIfe
Variables, Eects on work producvity and funcon-
al outcomes in Malaysia
Observaonal
Study : Clinical
Economics
7NMRR-10-
983-7456Rheumatology QEH I
A Phase 3, Mulcenter, Randomized, Double-
Blind,Placebo-Controlled Study to Evaluate the Ecacy
and Safety of Subcutaneous LY2127399 in Paents
with Systemic Lupus Erythematosus (SLE)
IntervenonalStudy : Clinical
Trial
8NMRR-10-
1203-7871Rheumatology QEH I
A randomized, double-blind, parallel-group study of
safety and the eect on clinical outcome of tocili-
zumab SC versus placebo SC in combinaon with
tradional disease modifying an-rheumac drugs
(DMARDs) in paents with moderate to severe ac-
ve rheumatoid arthris
Intervenonal
Study : Clinical
Trial
9NMRR-09-
200-3744Rheumatology QEH I
A Long-Term, Open-Label Follow-Up Study of Tofa-
cinib (CP-690,550) For Treatment of Rheumatoid
Arthris. Protocol No. A3921024
Intervenonal
Study : Clinical
Trial
10NMRR-11-
865-9930Pathology QEH I
Scienc Partnership for HER2 Tesng Excellence
(SPHERE) Clinical Audit
ObservaonalStudy : Paent
registry/Clinical
database
11NMRR-11-
800-10093Hematology/
ENT/ OncologyQEH I/
HWKKS
Cancer and Its Economic Impact on Household in the
ASEAN Countries HOUSEHOLD IN THE (ACTION
Study)
Observaonal
12*NMRR-13-
127-14699Oncology HWKKS
A three-arm, randomized, open label, phase II study
of everolimus in combinaon with exemestane ver-
sus everolimus alone versus capecitabine in the
treatment of postmenopausal women with estrogen
receptor posive, locally advanced, recurrent, or
metastac breast cancer aer recurrence or pro-
gression on prior letrozole or anastrozole
Intervenonal
Study : Clinical
Trial
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CRC Sabah NewsletterIssue 2 (May-Aug 2013)
No NMRR_IDDepartment/
Unit
Site
InstuonResearch Title
Research
Subtype
13NMRR-12-900-
13137Hematology QEH I
A Randomized, Open-label, mulcenter study to eval-
uate paent preference with subcutaneous admin-
istraon of Rituximab versus intravenous Rituximab in
previously untreated paents with CD20+ diuse
large B-Cell Lymphoma or CD20+ Follicular Non-
Hodgkin's Lymphoma grade 1,2 or 3a
Intervenon-
al Study :
Clinical Trial
14NMRR-12-181-
10976
Gastroenterol-
ogyQEH I
A Mul-centre, Randomised, Double
-blind, Placebo
-
controlled Trial to Determine the Ecacy and Safety
of Hepar-P Capsule for the Treatment of Non-
Alcoholic Fay Liver Disease (NAFLD)
Intervenon-
al Study :
Clinical Trial
15NMRR-11-1010-
10697
Gastroenterol-
ogyQEH I
A Phase 3, Safety and Ecacy Study of Boceprevi-
r/Peginterferon Alfa-2a/ribavirin in Chronic HCV Gen-
otype 1 IL28B CC Subjects
Intervenon-
al Study :
Clinical Trial
16NMRR-12-493-
11112Respiratory QEH I
A randomized, double-blind, double-dummy, 4-week
treatment, parallel-group study to evaluate the eca-
cy and safety of two doses of mometasonefuroate
delivered via Concept1 or Twisthaler in adult and
adolescent paents with persistent asthma
Intervenon-
al Study :
Clinical Trial
17NMRR-10-198-
5403Cardiology QEH 2
ProspeCve observaonal LongitudinAlRegIstryoF
paents with stable coronary arterY disease
Observaon-
al Study :
Paent reg-
istry/Clinical
database
18NMRR-12-690-
13000Cardiology QEH 2
Asian Sudden Cardiac Death in Heart Failure (ASIAN-
HF) Prospecve Observaonal Registry
Observaon-
al Study :
Clinical Epi-
demiology
19NMRR-08-1443-
2996Cardiology QEH 2
Heart Outcomes Prevenon Evaluaon
(HOPE)-3
Observaon-
al Study
20*NMRR-12-715-
12597Cardiology QEH 2
A Double-blind, Randomized, Placebo
-controlled,
Mulcenter Study Assessing the Impact of Addional
LDL-Cholesterol Reducon on Major Cardiovascular
Events When AMG 145 is Used in Combinaon With
Stan Therapy In Paents with Clinically Evident Car-
diovascular Disease
Intervenon-
al Study :
Clinical Trial
21*NMRR-12-
1102-13587Cardiology QEH 2
A Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group Study to Evaluate the Eect of
SAR236553/REGN727 on the ocurrence of Cardiovas-
cular Events in Paents Who Have Recently Experi-
enced an Acute Coronary Syndrome
Intervenon-
al Study :
Clinical Trial
22NMRR-10-753-
6795Psychiatrics HMBP
A Randomized, Double-blind, Placebo-Controlled,
Parallel-Group Study of PaliperidonePalmitate Evalu-
ang Time to Relapse in Subjects With SchizoaecveDisorder
Intervenon-
al Study :
Clinical Trial
23
*NMRR-12-826-
13119 Psychiatrics HMBPA Phase 3, Mulcentre, Randomized, Double-blind,
Placebo-controlled Trial to Evaluvate the Ecacy,
Safety, and Tolerability of Brexpiprazole(OPC-34712)
as Maintenance Treatment in Adults with Schizophre-
nia
Intervenon-
al Study :
Clinical Trial
24NMRR-09-654-
4406Oncology HWKKS
A Randomized, Mulcenter, Open-Label, Phase 3
Study to Compare the Ecacy and Safety of Pani-
tumumab and Cetuximab in Subjects with Previously
Treated, Wild-Type KRAS, Metastac Colorectal Can-
cer
Intervenon-
al Study :
Clinical Trial
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CRC Sabah NewsletterIssue 2 (May-Aug 2013)
No NMRR_ID Department/Unit SiteInstuon Research Title ResearchSubtype
25NMRR-11-395-
9024Oncology HWKKS
A Open-Label Study of Abiraterone Acetate in Sub-
jects with Metastac Castraon-Resistant Prostate
Cancer Who Have Progressed Aer Taxane-Based
Chemotherapy
Intervenon-
al Study :
Clinical Trial
26NMRR-11-991-
9842 Oncology HWKKS
A Randomized, Double-blind, Placebo-controlled
Study to Evaluate the Long-term Safety and Ecacy
of Darbepoen Alfa Administered at 500 g Once-
Every-3-Weeks in Anemic Subjects With Advanced
Stage Non-small Cell Lung Cancer Receiving Mul-
cycle Chemotherapy
Intervenon-
al Study :Clinical Trial
27NMRR-11-1020-
10569Oncology HWKKS
A phase II prospecve, two-cohort non-randomized,
mulnaonal, open label study to assess the safety of
assisted-and self-administered subcutaneous
Trastuzumab as therapy in paent with operable
HER2-posive early breast cancer
Intervenon-
al Study :
Clinical Trial
28NMRR-12-50-
10793
Paediatric
(Infecous
Disease)
HWKKS
A hospital-based, retrospecve study of the burden of
community acquired pneumonia in children aged
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Newslet ter Ti t le Page 7
Table 3: Summary of ISR Status in Sabah. 2008 - 2013.
ISR Status Total
ISR CompletedISR OngoingSR UpcomingISR Terminated
3535911
Total 90
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CRC Sabah NewsletterIssue 2 (May-Aug 2013)
NEW CRC HQE2 ROOM, 28th JUNE 2013
R E S E A R C H P R O T O C O L D E V E L O P M E N T W O R K S H O P , H Q E 2 , 1 8 - 1 9 T H M A Y 2 0 1 3
THERMO GUARD INSTALLATION & TRAINING, HQE2, 4th JULY 2013Thermoguardis a system for automac central
temperature monitoring. It is an industry standard for
online temperature and humidity control via a computer
network. In CRC, Thermoguardhas been used to monitor
refrigerators that store the Invesgaonal Product (IP) in
which the temperature needs to be maintained at a
certain level. The system comprises intelligent sensor
controllers with a network connecon, temperature
sensor connected to the network and the Thermoguard
soware.
VISIT AND MEETING FROM CRM OFFICER, 8-9th JULY 2013
Page 6
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CRC Sabah NewsletterIssue 2 (May-Aug 2013) Page 9
Site Initiation Visit ODYSSEY, HQE2 17th JULY 2013
RESEARCH AWARENESS DAY , HOSPITAL KENINGAU, 27th JULY 2013
Workshop on Basic Medical Biostatistics Using SPSS, SPU UMS, 27-28th Aug 2013
CRC Sabah Network Meeting, CRC HQE, 15th August 2013
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Page 8CRC Sabah NewsletterIssue 2 (May-Aug 2013)
Clinical Research Centre Sabah, Hospital Queen Elizabeth (CRC,HQE) has developed a
standard operating procedure for the research consultation clinic. It started the first formalresearch consultation clinic on 1 April 2013.
39.3%(11 out of 28) of them were specialists from various departments. It was followed bypharmacists (25%) and medical officers (21.4%). Other categories of researchers who did cometo the research consultation clinic were science officers, medical lab technologists and dieticians.
PRO GRESS REPO RT O F RESEARC H CONSULTATION C L INIC (RCC)
Since the setting up of the research clinic, the response has been quite good. We recorded the
highest number of researchers in July 2013 (15 clients with 9 new appointments). The ratio of
new appointments and follow up appointments in a month was 1:2. The cumulative number of
clients up to the end of Aug 2013 was 28 with 45 appointments.
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CRC Sabah NewsletterIssue 2 (May-Aug 2013)
Most of them were at the protocol development stage at the first consultation. About two thirds(67.8%, 19 researchers) came at the early stage of their research (ranging from literature searchto protocol review). 25% of them came for help in the data entry and analysis.
Page 11
About 35.7% of them were still in the protocol development stage at the end of August 2013.25%were at the process of data involvement either collection or analysis of the data. 7 of them (25%)have finished their research and had been writing their reports (2) or presented their researchresults at a conference (5).
0
1
2
3
4
5
No
type
Type of first consultation
10
5
4
3 3
2
0
2
4
6
8
10
12
No
Outcome
Research outcome
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Contact UsClinical Research Centre
Hospital Queen Elizabeth
Locked Bag No 2029
88586 Kota Kinabalu
Sabah
Tel: 088-517507
Fax: 088-211906
Email: [email protected]
Clinical Research Centre
Level 5, Cardiology Clinic
Hospital Queen Elizabeth IILorong Bersatu
Off Jalan Damai Luyang
88300 Kota Kinabalu
Sabah
Tel: 088-324600 (2019)
Fax: 088-272454
Clinical Research Centre
Hospital Wanita Dan Kanak-Kanak(Hospital Likas)
Karung Berkunci No 187
88996 Kota Kinabalu
Sabah
Tel : 088-522600
Upcoming Events1. Inaugural Sabah Medical Research and Scienc Conference In Conjuncon With Sabah
Research Day 2013
Date : 18-19 October 2013 ( PGMC, Hospital Queen Elizabeth)
Research Consultation ClinicProvide consultation services to facilitate
researchers in:
1. Research ideas
Literature Search
2. Research proposals Study design
Sample size calculation
Statistical analysis
3. Data analysis
4. Presentation / publication
Consulting services are provided at the CRC unit.
An appointment is required, and may be made
by email or by phone:[email protected],
Tel: 088-517507 or 088-324600 ext 2019).
TENTATIVE CONFERENCE PROGRAMPRE-CONFERENCE WORKSHOP18th October 2013 (Friday)
8.00 am 11.45 amMAIN CONFERENCE DAY 118th October 2013 (Friday)8.00 am 5.00 pmMAIN CONFERENCE DAY 219th October 2013 (Saturday)
7.30 am 5.00 pm
Good Clinical Practice Refresher Workshop Opening ceremony by Deputy Director General of Health, Ministry of Health Malaysia Keynote lecture 1 & 2
Keynote lecture 3, 4, 5 & 6 Oral Presentation Competition 1 & 2 Sessions Announcement of winners and prize giving ceremony
2. Intermediate Biostascs Workshop
Date: 28-30 October 2013
Venue: Sekolah Perubatan (SPU), UMS
Day Venue Time
Monday CRC, HQE 8.00am-12.00 noon2.30pm-4.30pm
Tuesday CRC, HQE 2(Level 5, Cardiology Clinic)
8.00am-12.00 noon2.30pm-4.30pm
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