2017 Clinical Research Centre Queen Elizabeth II Hospital II

 
2017 Clinical Research Centre Queen Elizabeth II Hospital II
2017

                                   ANNUAL REPORT
Clinical Research Centre
Queen Elizabeth II Hospital II
2017 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
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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

                                                                                        3
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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)

                             6

                             5

                             4

                             3
                                                                                                  2
                             2

                             1

                             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
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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%

                         300%

                         250%
 RECRUIMENT PERCENTAGE

                         200%
                                                                                                        
                         150%

                         100%

                         50%

                          0%

                                                               REGISTRY/CLINICAL TRIAL

                                                           INDUSTRIAL SPONSORED RESEARCH (CRC HQE II)

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

                                                                                                                                6
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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.

                                                                                                                      8
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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.
2017 Clinical Research Centre Queen Elizabeth II Hospital II
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

               3

                                                  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.

                                                                                                                                           10
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

                 9

                 8

                 7               8
                 6
     Frequency

                 5

                 4

                 3

                 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
                                                                                                              11
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                                                              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.

                                                                                                                                       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.

                                                                                                                    14
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.

                                                                                                              15
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
                                                                                                                    16
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
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