CRC SABAH NEWSLETTER · ISSUE 3: September – December 2013 CRC Sabah Newsletter MESSAGE AND...

Issue 3 : September– December 2013

CRC’s OBJECTIVE 1. To promote a culture of research among healthcare workers in Sabah. 2. To disseminate skills in Methodology, Statistical tools, and techniques in designing and conducting clinical trials. 3. To provide healthcare workers the principle of methodology and biostatistics in clinical research

Warmest Greeting from CRC Sabah! Welcome 2014, and Happy New Year! As we begin this New Year, we hope that 2014 will bring bigger and better things for the Clinical Research Centre (CRC).

In This issue, we want to announce the upcoming workshop organized by CRC Sabah for the year 2014.

1. Good Clinical Practice (GCP) Workshop collaboration with Clinical Research Malaysia (CRM) 19th – 21st Feb 2014, Sabah Women and Children Hospital.

2. Sabah Good Clinical Practice (GCP) Workshop 26th – 28th Mar 2014, Hospital Queen Elizabeth II.

3. Basic to Intermediate Medical Biostatistics Using SPSS Workshop 2014 14 – 17 April 2014, School Of Medical, University Malaysia Sabah (UMS).

4. Advanced Medical Biostatistics Using SPSS Workshop 2014 2 – 6 Jun 2014, School Of Medical, University Malaysia Sabah (UMS).

Grab this opportunity and never stop Learning! See you there!

To be a leading clinical research institution in Asia

To improve patients health outcomes through ethical

and quality clinical research.

CRC SABAH NEWSLETTER

Inside This Issue

Welcome to Issue 3 of CRC Sabah Newletter

Investigator Initiated Research (IIR) and industry Sponsored Research (ISR) updates

Activities and Photo Gallery

Contact Us

Upcoming Events

CRC’s Vision

CRC’s Mission

WELCOME TO ISSUE 3 OF CRC NEWSLETTER

ISSUE 3: September – December 2013 CRC Sabah Newsletter

MESSAGE AND RESOLUTION CRC SABAH HEAD 2014

First and foremost, I would like to congratulate the editorial team for their success in publishing the third edition of CRC Sabah Newsletter. This latest edition marks another important milestone for CRC Sabah. It has been more than 5 years since the inception of CRC Sabah. Since then we have seen the number of industry-sponsored research and investigator-initiated research activities increase. CRC Sabah is committed to promote a research culture at all levels of the MOH in Sabah. In order to achieve this CRC Sabah has visited 13 district hospitals in the north, west and interior of Sabah. These visit helped to promote CRC services and resolve problems with regard to research matters in the districts. CRC Sabah will cover the hospitals in eastern Sabah this year.

In addition, CRC will organize numerous courses such as a Biostatistics Workshop, Research Proposal Development workshop and Good Clinical Practice workshop. This is to disseminate information to healthcare providers the proper way of conducting research. We hope to strengthen research capability through long lasting collaborations with local institutions and other hospitals. Additionally, we hope to facilitate research activities with emphasis on quality research from these collaborations.

Finally, I wish to thank all the staff of CRC Sabah for working tirelessly to achieve these objectives. Enjoy reading.

Datuk Dr Jayaram Menon Head of CRC Sabah Hospital Queen Elizabeth

Thank you for the opportunity to say a few words.

Congratulations to the editorial team from CRC Likas for producing the third edition of CRC Sabah Newsletter.

2013 has seen a number of successful industry sponsored research (ISR), which is the main focus at our centre. A Good Clinical Practice (GCP) Workshop will be held from 19-21 February 2014 in Likas Hospital itself, specially organised by Clinical Research Malaysia (CRM) in collaboration with CRC Sabah.

We hope to increase awareness in clinical research as well as to cultivate the research culture and have responsible investigators to conduct studies of high quality. We are committed to assist all the disciplines which are interested to conduct research, within our capabilities. Last but not least, I wish everyone a happy new year!

Dr Flora Chong Li Tze Head of CRC Hospital Likas


NO

NMRR ID

STUDY TITLE

STUDY SITE

1 NMRR-13-425-14815 Substance use among psychiatric inpatients in Duchess of Kent Hospital, Sandakan

Duchess of Kent Hospital, Sandakan

2 NMRR-13-354-16253 Amalan Gaya Hidup Sihat di Kalangan Paramedik Hospital Kuala Penyu

Kuala Penyu Hospital

3 NMRR-13-546-16814

Attitude and Perceptions of Healthcare Professionals towards Clinical Pharmacy Services in Lahad Datu Hospital

Lahad Datu Hospital

4 NMRR-12-134-13359

Mengkaji faktor-faktor yang mempengaruhi kesan psikososial terhadap pesakit talasemia.

QEH I/ Keningau/ HWKKS

5 NMRR-13-677-15713

Determining the Aetiology of Non-Malarial Acute Febrile Illness in Sabah QEH I/ HWKKS/ Kudat/Kota Merudu

6 NMRR-13-574-16749 CD44s expression in soft tissue sarcomas, a potential prognostic marker QEH I

7 NMRR-13-858-14725

The study of b-Thalassemia trait among adolescents in sabah, east malaysia, a population study

QEH I

8 NMRR-13-800-15838

Survey on knowledge of psychotropic medications among paramedics and nurses in Hospital Mesra Bukit Padang

HMBP

9 NMRR-13-804-16974 Risk factors of pacemaker Implantation Infection: a single centre experience. QEH II

10 NMRR-13-813-17173

Amalan kepatuhan rawatan tibi secara dot dalam kalangan pesakit tibi di Klinik kawalan tibi dan kusta Lahad Datu, Sabah.

Jabatan Pesakit Luar, Klinik Kesihatan Lahad Datu

11 NMRR-13-842-17444

Census on patients completing one year treatment of adjuvant Trastuzumab from January 2012 till July 2013 at Hospital Likas, Kota Kinabalu, Sabah.

HWKKS

12 NMRR-13-800-15838

Survey on knowledge of psychotropic medications among paramedics and nurses in Hospital Mesra Bukit Padang

HMBP

13 NMRR-13-804-16974 Risk factors of pacemaker Implantation Infection: a single centre experience. QEH II

14 NMRR-13-842-17444 Census on patients completing one year treatment of adjuvant Trastuzumab

from January 2012 till July 2013 at Hospital Likas, Kota Kinabalu, Sabah. HWKKS

15 NMRR-13-639-16766 A Randomized Controlled Study on Compliance towards MASA 1956 among Retail Pharmacies in Sabah

Cawangan Penguatkuasa Farmasi, Jabatan Kesihatan Negeri Sabah.

16 NMRR-13-649-16823 A Pilot Study of Barriers Towards Quit Smoking among Participants of Quit Smoking Clinic in Hospital Duchess of Kent, Sandakan.

HDOK

17 NMRR-13-732-16497 Implementation of hospital information system (his) in Malaysian public hospitals

Kunak/ Keningau/ Lahad datu Hosp

18 NMRR-13-843-16712

Human-animal Exposure Study in Malaysia, Kinabatangan District, Sabah State, Malaysia

JKNS

19 NMRR-13-906-16967

Epidemiological and Clinical Profile of Transfusion Dependent Thalassemia Patient in Sabah

QEH I/ HDOK

Table 1: Investigator Initiated Research (IIR) Approved by MREC


20 NMRR-13-1192-18473

Neonatal jaundis teruk: kegagalan ibu mematuhi rujukan pemeriksaan serum bilirubin mengakibatkan peningkatan kes neonatal jaundis teruk di daerah Sandakan.

Pejabat Kesihatan Kawasan Sandakan

21 NMRR-13-642-17166 Outcome of Pharmacist Intervention on Medication Compliance among Hemodialysis patients in Lahad Datu Hospital

Lahad Datu Hosp

22 NMRR-13-875-17115 Fluoride enamel opacities among 16-year-old school children in Malaysia

Oral Health Division, MOH, JKNS

23 NMRR-13-962-17898 Cardiovascular risk management among primary care patients in Malaysia Klinik Kesihatan Luyang

24 NMRR-13-915-16059

A retrospective Assessment of Integrated-Quit-Smoking-Service in Primary Healthcare Setting

Klinik Kesihatan Luyang

25 NMRR-13-373-14897 Current status of Drug Information Centers in Malaysia JKNS

26 NMRR-13-891-17366 DEB-only All Comers Registry QEH II

27 NMRR-13-904-16833

HER-2 Expression and Amplification in locally advanced, metastatic or unresectable gastric and gastroesophageal junction adenocarcinoma population in PPNR, Sabah.

HWKKS

28 NMRR-13-1001-15684

The Effectiveness of Online Training for Interpretation of Video fluoroscopy of Swallowing Study Among Speech-Language Therapists in Malaysia.

QEH I/ HDOK

29 NMRR-13-883-16902 Program Pengubatan Beramai-ramai (MDA) Filariasis Limfatik Penduduk Di Kampung Keramat, Beluran, Sabah.

Pejabat Kesihatan Kawasan Beluran

30 NMRR-13-725-16306

Isolation of methicillin-resistant staphylococcus aureus (mrsa) from nasal swab in heterogenous studied group population

QEH I

31 NMRR-13-599-16838

Medication therapy optimization clinic (mtoc) dyslipidemia: evaluation of a pharmacist-managed lipid clinic that uses a novel lipid titration protocol

Tawau Hospital

32 NMRR-13-551-16402 Liver impairment in paediatric thalassaemia patients on deferasirox HDOK

33 NMRR-13-1066-17354

International multicentre prevalence study on sepsis QEH I/ QEH II/ Keningau/ HDOK/ Lahad Datu

34 NMRR-13-1088-17518

Psychometric evaluation of the malay version of alcohol use disorder identification test (audit-m)

Klinik Kesihatan Penampang

35 NMRR-13-1092-16922

Physician's satisfaction with the performance of pharmacists in pharmacist-involved anticoagulation clinic, Queen Elizabeth Hospital II

QEH II

36 NMRR-13-1023-14660

Identifying psychosocial and economic risk factors and quantifying the costs of age-related cognitive impairment: implications of population aging in Malaysia

QEH I

37 NMRR-13-1195-17901

Pharmacist-initiated lung function screening using validated copd-ps questionnaire followed by vitalograph copd-6 to detect the impaired lung function in people at risk of developing COPD in primary health care setting.

Klinik Kesihatan Luyang

38 NMRR-13-1167-18340

Kajian dalam dokumentasi penjagaaan pesakit yang menyebabkan bebanan di kalangan jururawat di Queen Elizabeth Hospital II

QEH II


NO NMRR ID Department/ Unit

Site Institution

Research Title

Research Subtype

1 NMRR-08-1377-2750

Oncology

HWKKS

Multicenter, randomized, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus

Interventional Study : Clinical Trial

2 NMRR-09-200-3744

Rheumatology HQE I

A Long-Term, Open-Label Follow-Up Study of Tofacitinib (CP-690,550) For Treatment of Rheumatoid Arthritis. Protocol No. A3921024


3 NMRR-09-401-4109

Rheumatology HQE I

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFá Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy.


4 NMRR-09-654-4406

Oncology HWKKS

A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-Type KRAS, Metastatic Colorectal Cancer


5 NMRR-10-628-5357

Nephrology HQE I

Phase IIb/III Clinical Study Protocol - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis) -


6 NMRR-10-198-5403

Cardiology HQE II

Prospective observational LongitudinAl Registry oF patients with stable coronary arterY disease.

Observational Study : Patient registry/Clinical database

7 NMRR-10-1193-5556

Rheumatology HQE I

An observational study of Rheumatoid arthritis patients on adalimumab to Evaluate quality of LIfe Variables, Effects on work productivity and functional outcomes in Malaysia

Observational Study : Clinical Economics

8 NMRR-10-706-6055

Endocrinology HQE I

A Phase III, multicentre, international, 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 patients with increased cardiovascular risk.


9 NMRR-10-753-6795

PSY HMBP

A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder


10 NMRR-10-983-7456

Rheumatology HQE I

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)


11 NMRR-10-1203-7871

Rheumatology HQE I A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of Tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis


12 NMRR-11-395-9024

Oncology HWKKS A Open-Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy


13 NMRR-11-991-9842

Oncology HWKKS A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 ìg Once-Every-3-


Table 2 : Ongoing Industry Sponsored Research (ISR) In Sabah. August – December 2013


Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

14 NMRR-11-

865-9930

Pathology HQE I Scientific Partnership for HER2 Testing Excellence (SPHERE) Clinical Audit


15 NMRR-11-800-10093

ENT/ Haematology/ Oncology

HQE I/ HWKKS

Cancer and its economic impact on household in the Asean countries (action study)


16 NMRR-11-1020-10569

Oncology HWKKS A phase iii prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous Trastuzumab as therapy in patients with operable her2-positive early breast cancer


17 NMRR-11-1010-10697

Gastroenterology HQE I A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects


18 NMRR-12-50-10793

Pediatrics HWKKS A hospital-based, retrospective study of the burden of community acquired pneumonia in children aged <5 years in Indonesia, Malaysia, South Korea and Vietnam

19 NMRR-12-181-10976

Gastroenterology HQE I A Multi-centre, Randomised, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Hepar-P Capsule for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)


20 NMRR-12-426-11014

Rheumatology HQE I A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)


21 NMRR-12-493-11112

Respiratory HQE I A randomized, double-blind, double-dummy, 4-week treatment, parallel-group study to evaluate the efficacy and safety of two doses of Mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthma


22 NMRR-12-322-11499

Rheumatology HQE I A randomized, double-blind placebo-controlled study of the maintenance of efficacy of Atanercept plus dmard(s) compared with dmard(s) alone in subjects with rheumatoid arthritis after achieving an adequate response with etanercept plus dmard(s).


23 NMRR-12-419-12390

Oncology HWKKS A randomized, multicenter, adaptive phase ii/iii study to evaluate the efficacy and safety of Trastuzumab Emtansine (t-dm1) versus Taxane (Docetaxel or Paclitaxel) in patients with previously treated locally advanced or metastatic her2-positive gastric cancer, including adenocarcinoma of the Gastroesophageal junction


24 NMRR-12-715-12597

Cardiology HQE II A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease


25 NMRR-12-914-12832

Oncology HWKKS A randomized, phase iii, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of Onartuzumab (metmab) in combination with 5-fluorouracil, folinic acid, and oxaliplatin (mfolfox6) in



patients with metastatic her2-negative, met-positive Gastroesophageal cancer

26 NMRR-12-690-13000

Cardiology HQE II Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) Prospective Observational Registry

Observational Study : Clinical Epidemiology

27 NMRR-12-770-13097

O&G HWKKS A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women


28 NMRR-12-826-13119

PSY HMBP A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Trial to Evaluvate the Efficacy, Safety, and Tolerability of Brexpiprazole(OPC-34712) as Maintenance Treatment in Adults with Schizophrenia


29 NMRR-12-900-13137

Haematology HQE I A randomized, open-label, multi-centre study to evaluate patient preference with subcutaneous administration of rituximab versus intravenous rituximab in previously untreated patients with cd20+ diffuse large b-cell lymphoma or cd20+ follicular non-Hodgkin's lymphoma grades 1, 2 or 3a


30 NMRR-12-1102-13587

Cardiology HQE II A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the ocurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome


31 NMRR-12-1096-13654

Oncology HWKKS A double-blind, placebo-controlled, randomized, multicenter phase iii study evaluating the efficacy and safety of Pertuzumab in combination with Trastuzumab and chemotherapy in patients with her2-positive metastatic Gastroesophageal junction and gastric cancer


33 NMRR-12-1071-13841

Rheumatology HQE I A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody- Positive Systemic Lupus Erythematosus Receiving Belimumab

Observational Study : Clinical Economics

34 NMRR-12-1283-14486

Oncology HWKKS A phase IIIb, multi-center, open-label, expanded access study of Everolimus (RAD001) in combination with Exemestane in post-menopausal women with Estrogen receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer EVEREXES


35 NMRR-13-58-14559

Opthalmology HQE I "Prospective, double-blind, placebo-controlled, randomized, parallel-group, multi-center study with an open-label extension period to investigate the efficacy and safety of two different doses of NT 201 in Botulinum toxin treatment-naïve subjects with Blepharospasm"


36 NMRR-13-54-14597

Pediatrics HWKKS Understanding Adherence, Stigma, and Behavioral Risk Factors of Adolescents in the TREAT Asia Pediatric HIV Observational Database using an Audio Computer-Assisted Self Interview (TApHOD ACASI)


37 NMRR-13-127-14699

Oncology HWKKS A three-arm, randomized, open label, phase II study of Everolimus in combination with Exemestane versus Everolimus alone versus Capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic



breast cancer after recurrence or progression on prior letrozole or anastrozole

38 NMRR-13-197-14838

Gen Medical Keningau Hospital

An International Survey on Hypoglycaemia among Insulin-treated Patients with Diabetes - Non Interventional study


39 NMRR-13-96-15078

Gen Medical Keningau Hospital

DiabCare Asia 2012 - Malaysia A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of patients with type 2 diabetes in Malaysia Non-Interventional study

Observational Study : Clinical Epidemiology


Activities and Photo Gallery

SABAH RESEARCH DAY 2013

Opening CRC Building by Datuk Dr Jeyaindran Tan Sri Sinnadurai

18 Oct 2013

Opening Ceremony Sabah Research Day 2013 by Datuk Dr Jeyaindran Tan Sri

Sinnadurai 18 Oct 2013.

Poster Visit by Datuk Dr Jeyaindran

Sabah Research Day 2013 : The Speakers Sabah Research Day 2013 : The Secretariat


Sabah Research Day 2014 Participants

CRC DISTRICT VISIT

Objective: To promote CRC services and to attempt resolve problems in regards to research matters in districts.

CRC District Visit HOSPITAL TAMBUNAN Date: 07 November 2013 Total Participant: 24

CRC District Visit

HOSPITAL RANAU Date: 06 November 2013 Total Participants: 29


CRC District Visit

HOSPITAL TUARAN Date: 03 December 2013 Total Participants: 15

CRC District Visit

HOSPITAL PAPAR Date: 12 November 2013 Total Participants: 13

NCCR 3-5 SEPT 2013, HOTEL SERI PACIFIC, KUALA LUMPUR


RESEARCH CAMP ALUMNI 5 SEPT 2013, HOTEL SERI PACIFIC, KUALA LUMPUR

KURSUS PENGENDALIAN SAMPEL MAKMAL (7 NOV 2013), MAKMAL PATOLOGI HQE ll

COLLABORATION MEETTING BETWEEN SPU, UMS and CRC Sabah (21 Nov 2013), UMS Block, QEH


LAWATAN SAMBIL BELAJAR KE CRC HWKKS 15 NOV 2013

CRC HWKKS APPRECIATION AND CHRISTMAS LUNCH, (21ST DECEMBER 2013) SOUL OUT RESTAURANT, GRAND BORNEO HOTEL


CONTACT US

Clinical Research Centre Hospital Queen Elizabeth I 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 II Lorong Bersatu Off Jalan Damai Luyang 88300 Kota Kinabalu Sabah Tel: 088-324600(2019) Fax: 088-272454 Clinical Research Centre, 7th Floor, Pusat Perubatan Nuklear dan Radioterapi, Hospital Wanita dan Kanak-kanak Sabah (Hospital Likas), 88996 Kota Kinabalu, sabah. Tel:088-522600 (2272)

Fax: 088-435734

RESEARCH CONSULTATION CLINIC

Provide consultation services to facilitate researchers in:

1. Research idea

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 maybe made by email or by phone:

[email protected]

[email protected]

Tel : 088-517507 or 088-324600 ext 2019

DAY VENUE TIME

Monday

CRC,HQE 8.00am-12.00 noon 2.30pm-4.30 pm

Tuesday

CRC,HQE II 8.00am-12.00 noon 2.30 pm- 4.30 pm

UPCOMING EVENT

1. Good Clinical Practice (GCP) Workshop collaboration with Clinical Research Malaysia (CRM) 19th – 21st Feb 2014, Sabah Women and Children Hospital.

2. Sabah Good Clinical Practice (GCP) Workshop 26th – 28th Mar 2014, Hospital Queen Elizabeth II.

3. Basic to Intermediate Medical Biostatistics Using SPSS Workshop 2014 14 – 17 April 2014, School Of Medical, University Malaysia Sabah (UMS).

4. Advanced Medical Biostatistics Using SPSS Workshop 2014 2 – 6 Jun 2014, School Of Medical, University Malaysia Sabah (UMS).

mailto:[email protected]

tel:088-522600



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