The document provides an overview of research activities and outputs from Clinical Research Centres (CRCs) in Perak, Malaysia from 2018-2020. Key points include:
- CRCs in Ipoh, Seri Manjung and Taiping have seen increases in research projects, publications, and consultations from 2018-2020, with the largest CRC in Ipoh leading research activities.
- Investigator initiated research projects have increased year-over-year across all three CRCs, resulting in growth of local/international publications and presentations.
- Industry-sponsored clinical trials have also increased at two of the three CRCs over the period.
- CRCs provide important research services like ethics appro
Malaysia to Initiate First COVID-19 Vaccine Trial in Early 2021
1. Greetings everyone and welcome to the third edition of
the CRC Perak Network Bulletin. We are currently in
the midst of a devastating pandemic. It all started at the
end of 2019 in Wuhan China. Not long after that almost
every country has been affected. As of 23 December
2020, there are a total of 98,737 confirmed cases in
Malaysia and 76,858,506 confirmed cases globally.
The causative organism is a corona virus which is in the
same subgenus as SARS and MERSCOV. After almost
a year we are still battling the pandemic. The end is
nowhere in sight. Majority of the countries are still trying
to control the spread. So where do we fit in? What role
do we as researchers fit in the time of pandemic?
There are still many questions remain unanswered.
They can only be answered with research. Research
into the epidemiology, management and vaccines is
desperately needed. Not only that, pandemic like this
can cause lots of impact on medical personnel as well
as public and through research we will be able to gauge
the depth of the impact. There are no specific treat-
ments available yet. Vaccines are now the only way to
control and by no mean stop the pandemic. There are
many on the horizon, and they are being developed
very quickly
We still need answers and it is only through research that we
can find them. With them we will be able to unlock the
mystery of COVID-19 and hopefully eradicate it like we have
done with small pox and polio. We currently do not have an
effective treatment regime as most of the clinical trials do not
show promising results. The administration of antibodies
extracted from patients in convalescent phase proves to be
effective in certain patients, hence again more research is
needed. No antiviral drug available now has been shown to
be effective.
Even with vaccines available there are so much more to
learn about them such as the immune response and how
long it last as well as long term side effects. We now know,
through research, the virus is highly mutable hence vaccines
might not work in different regions. However, few countries
like United Kingdom and USA has started vaccination
programs for the front-liners and high-risk populations.
As of September 2020, in Perak state there are 32 studies
related to Covid-19 in progress and hopefully many more will
be initiated. Hopefully by the end of 2021 Covid-19 will be
history. With that till the next edition of Perak CRC Bulletin,
have a great and progressive researchful year ahead.
Issue 03
CRC Perak Network Bulletin
e-ISSN 2682-7867
Editorial Committee:
CRC HRPB Ipoh
Dr. Philip Rajan
Dr. Lim Xin Jie
Hasni Adha Ibrahim
Suria Junus
CRC Hospital Taiping:
Dr. Rosilawati Abdul Rani
Chua Kin Wei
CRC Hospital Seri Manjung:
Chiew Shoen Chuen
Norsarlizna Mat Sari
Advisors:
Perak State Health Director
Dr. Ding Lay Ming
Hospital Raja Permaisuri
Bainun, Ipoh Director
Dr. Abdul Malek bin Osman
Hospital Taiping Director
Dr. Hjh Narimah Yusof
Hospital Seri Manjung Director
Dr. Nordin bin Nasir
2. Up to 20th December 2020, the cumulative cases of coronavirus disease (COVID-
19) in Malaysia was 93,309 cases, with a total active case of 15,563 cases. On
December 11, 2020, the U.S. Food and Drug Administration issued the first
emergency use authorization (EUA) for a vaccine for the prevention of COVID-19
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in
individuals 16 years of age and older. The emergency use authorization allows
the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
Malaysia is going to initiate the first
COVID-19 vaccine trial in early 2021.
This involves 3,000 volunteers from
eight public hospitals under the
Ministry of Health Malaysia. The trial is
classified as Phase 3 clinical trial, in
which the inactivated vaccine was
produced by the Institute of Medical
Biology Chinese Academy of Medical
Sciences in China. This study had been
registered in the National Medical
Research Registry (NMRR) and
received Medical Research and Ethics
Committee (MREC) approval.
The Clinical Research Centre (CRC) of
Hospital Raja Permaisuri Bainun was
selected as one of the site for this
trial. The purpose of this trial is to
evaluate the safety and efficacy of the
investigational vaccine, which had
elicited adequate antibody response
in the Phase 1 and Phase 2 stage. This
is a randomized, double-blinded,
placebo controlled trial which
involves 2 doses of intramuscular
injection with a 2-week interval.
Healthy volunteer above the age of
18 were encouraged to participate in
this trial.
Before participation, subjects are required to go through virology screening
(HIV and SARS-CoV-2). The eligible subjects will then be required to attend 6
on-site visits, for a duration of 12 months. The potential benefits of
participating in this trial is the development of immunity towards the SARS-CoV
-2 virus. Subjects will also receive routine medical follow-up and guidance on
health-related issues, to ensure their well-being. The investigational vaccines
will be given free of charge to the subjects.
Mr. Chang Chee Tao 2
3. While the safety of the investigational vaccine had been evaluated in
Phase I and Phase II trials, some common adverse events such as local
reactions include pain, swelling, redness and itchiness at the injection
site may happen. Additionally, subjects may experience common
systematic reactions such as fatigue, fever, and diarrhea etc. Acute
allergic reactions may happen in very small number of people.
Since this is a placebo-controlled trial, subjects
may be randomly received the control vaccine,
which would not elicit SARS-CoV-2 antibodies
response. Half of the subjects will be randomly
vaccinated with the investigational vaccine.
Even so, vaccination may not provide full
protection, and the ability of developing
resistance to the SARS-CoV-2 virus was not
guaranteed. Hence, all the subjects in this trial
were required to take continuous personal
precautions, according to the standard
guidelines by the Ministry of Health.
Participating in trial is a noble act, as it helps to develop potentially
lifesaving vaccines and contribute to the advancement of medicine and
humanity.
Purpose ?
To test if the COVID-19 vac-
cine is safe and effective
Who can be the volunteer?
Healthy adults, 18 years and
above
Why volunteer?
To contribute in finding a safe
and effective vaccine to protect
people from COVID-19
POSSIBLE BENEFITS
Free COVID-19 swab test
Physical examination by
doctors
Pain, swelling, redness and
itching at the injection site
Fatigue, fever, diarrhea,
etc
POSSIBLE RISKS
Randomized,
Double -Blinded,
Placebo Controlled
Phase III Clinical
Trial for the
Evaluation of
Efficacy and Safety
of SARS-CoV-2
Vaccine
Immunity towards COVID-19
3
4. COVID-19 Research Priorities Identified by the Global Research Community
Since the beginning of the Covid-19 outbreak, WHO has brought together the world’s scientist and health professionals to accelerate
understanding of the novel coronavirus and expedite research and development to find solutions to the pandemic. WHO has identified
the immediate and long term priorities, alongside the new priorities that were globally relevant, particularly to lower resource settings.
NEW RESEARCH PRIORITIES
Areas New Immediate priorities New Longer-term Priorities
Virus natural history,
transmission and diagnostics
Ensure effective measures including community
surveillance are in place to rapidly identify
emerging zoonotic diseases by developing ani-
mal screening techniques
Epidemiological studies Examine relationships to other lung diseases e.g.
Tuberculosis, Lung Cancer, Sarcoidosis, Idiopathic
Pulmonary Fibrosis
Research into long term health impacts and
complications of contracting COVID-19 – with
emphasis on children/those with comorbidities
The impact of improved WASH (Water, Sanita-
tion and Hygiene) practices on WASH-related
infections diseases.
Clinical Management Clinical guidelines for post-hospitalisation home
management and community rehabilitation. Palliative
care Vitamin D levels and disease severity
Infection prevention and
control
How to ensure effective social distancing in pub-
lic spaces and congregate settings post-
lockdown.
Therapeutics R&D Investigate the potential role of natural/alternative/
herbal/traditional remedies and practices in treat-
ment of COVID-19 Evaluate therapeutics in the com-
munity in early infection
Vaccines R&D Innovative vaccine delivery modalities
Ethics Considerations for
Research
Ethical considerations for resource allocation to
LMICs. Ethical considerations of recruitment of final
year medical/nursing students during the pandemic
Social Sciences in the Out-
break Response
Understanding COVID-19 in the contexts of conflict,
civil war, and refugee situations
Examine the effects of the pandemic on the par-
ticipation of the public in democratic processes
Source: The Global Health Network 4
5. Infection recurrence
Understanding infections and outcomes in vulnerable populations
including children, refugees, persons living with disabilities, ethnic
groups
Improved diagnostic tools for safer sample collection, faster and
easier assays
The effects of the disease on pregnant women
Health Systems research & strengthening to mitigate impact of
COVID-19 on capacity
Potential for zoonotic leap between human and companion animals
Health impact of redirecting resources and public health interventions towards
COVID-19 on mental health, reproductive maternal newborn and child health,
non-communicable diseases, other infectious diseases (especially vaccine
preventable disease, Dengue, HIV, chikungunya, tuberculosis, malaria, NTDs)
Adherence to public health interventions such as quarantine and
social distancing
Effectiveness of public health interventions
Public health messaging and addressing myths and mistrust
01
02
03
04
05
06
07
08
09
10
5
6. Investigator Initiated Research (IIR) in CRC Hospital Raja Permaisuri Bainun, Ipoh
Research Projects and Output 2018 2019 2020
IIR projects
No. of research projects initiated by CRC and/ or
in collaboration with other institutions
23 30 39
Publications
No. of published articles in local/ international jour-
nals
10 12 16
No. of manuscripts pending publication 7 7 9
Research re-
ports
No. of research reports completed 7 5 10
Research
presentation
No. of oral presentations 25 13 1
No. of poster presentations 13 14 8
Research
awards
No. of awards received 8 8 5
Industry Sponsored Research (ISR) in CRM/CRC Hospital Raja Permaisuri Bainun, Ipoh
Feasibility and Clinical Trials 2018 2019 2020
Feasibility No. of feasibility studies conducted 88 70 44
Clinical trials
No. of on-going clinical trials 40 28 36
No. of upcoming clinical trials 11 5 8
a
115 workshops were the training of standard operating procedure on BA/BE at CRC HRPB.
Research services provided by CRC Hospital Raja Permaisuri Bainun, Ipoh
Type of Research Service 2018 2019 2020
NMRR regis-
tration
No. of research/Case studies/Clinical audit registered 195 135 228
No. of research/Case studies/Clinical audit projects
with ethical approval
62 112 142
Research
consultation
No. of consultations (episodes) provided 972 627 638
Proposal re-
view
No. of proposals reviewed by Hospital Research Re-
view Committee (HRRC)
121 130 104
Publication &
presentation
submitted to
CRC Ipoh
No. of application of publication in local/ international
journals
5 11 12
No. of application of oral/poster presentation 38 39 9
Registry No. of patient registries supported 14 14 14
Training /
Conference
No. of training workshops organised 143a
25 18
No. of Ministry of Health staff trained 1953 1590 719
No. of state conferences organised 1 1 0
6
7. Research services provided by CRC Hospital Seri Manjung
Type of Research Service 2018 2019 2020
NMRR regis-
tration
No. of research/Case studies/Clinical audit regis-
tered
16 10 11
No. of research/Case studies/Clinical audit projects
with ethical approval
13 10 11
Research
consultation
No. of consultations (episodes) provided
196 379 432
Proposal re-
view
No. of proposals reviewed by Hospital Research
Review Committee (HRRC)
18 12 6
Publication &
presentation
submitted to
CRC Seri
Manjung
No. of application of publication in local/ internation-
al journals
11 3 8
No. of application of oral/poster presentation
14 19 0
Registry No. of patient registries supported 1 1 1
Training /
Conference
No. of training workshops organised 9 9 2
No. of Ministry of Health staff trained 304 478 103
No. of state conferences organised 1 1 0
Investigator Initiated Research (IIR) in CRC Hospital Seri Manjung
Research Projects and Output 2018 2019 2020
IIR projects
No. of research projects initiated by CRC and/or
in collaboration with other institutions
14 13 19
Publications
No. of published articles in local/international
journals
3 0 3
No. of manuscripts pending publication 1 3 4
Research re-
ports
No. of research reports completed 7 4 3
Research
presentation
No. of oral presentations 4 4 0
No. of poster presentations 1 2 4
Research
awards
No. of awards received 0 2 1
Industry Sponsored Research (ISR) in CRC Hospital Seri Manjung
Feasibility and Clinical Trials 2018 2019 2020
Feasibility No. of feasibility studies conducted 14 6 10
Clinical trials
No. of on-going clinical trials 9 8 9
No. of upcoming clinical trials 2 1 2
7
8. Research services provided by CRC Hospital Taiping
Type of Research Service 2018 2019 2020
NMRR regis-
tration
No. of research/Case studies/Clinical audit registered 25 29 15
No. of research/Case studies/Clinical audit projects
with ethical approval
25 29 13
Research
consultation
No. of consultations (episodes) provided 118 46 24
Proposal re-
view
No. of proposals reviewed by Hospital Research Re-
view Committee (HRRC)
32 29 14
Publication &
presentation
submitted to
CRC Taiping
No. of application of publication in local/ international
journals
2 5 7
No. of application of oral/poster presentation 3 6 3
Registry No. of patient registries supported 0 0 0
Training /
Conference
No. of training workshops organised 13 16 7
No. of Ministry of Health staff trained 275 296 165
No. of state conferences organised 0 0 0
Investigator Initiated Research (IIR) in CRC Hospital Taiping
Research Projects and Output 2018 2019 2020
IIR projects
No. of research projects initiated by CRC and/or in
collaboration with other institutions
7 7 5
Publications
No. of published articles in local/international jour-
nals
2 5 8
No. of manuscripts pending publication 0 0 1
Research re-
ports
No. of research reports completed 0 0 0
Research
presentation
No. of oral presentations 0 1 0
No. of poster presentations 3 5 3
Research
awards
No. of awards received 0 0 0
Industry Sponsored Research (ISR) in CRC Hospital Taiping
Feasibility and Clinical Trials 2018 2019 2020
Feasibility No. of feasibility studies conducted 15 18 8
Clinical trials
No. of on-going clinical trials 11 12 13
No. of upcoming clinical trials 6 5 2
8
9. No. Published Article
1
Sharon Linus-Lojikip, Nur fatin Zulaika, Norasmah Mt Isa, Noor Hazilah Che Nordin, Norfariza Mustapa, Kaplana Muniandy,
Harvinderjit Kaur, Lai Jia Min, Shin Pue Siah, Haymalatha Rajagam, Amar-Singh HSS. Improving the support of neonates
post discharged from neonatal intensive care unit (NICU) or special care nursery (SCN). International Journal for Studies on
Children, Women, Elderly and Disabled Persons. 2019. Vol 8 (Oct), 96-108). ISSN 0128-309X. Published online on 22 Jan
2020.
2
Sharon Linus-Lojikip, Nur Fatin Zulaikha, Jazilah Mohamed Nor, Norain Ahamad Romazul, Nur Hidayah Shamsuddin,
Rosmaanira Ngah, Rosuzila Kamaruddin, Sakinah Safiei, Wan Afifah Wan Mazlan, Lai Jia Min, Heama Shunmugarajoo, Nors-
hazila Julia MS, Amar-Singh HSS. Parents' knowledge on pneumococcal vaccine and opinions on payment strategies in Ma-
laysia. International Journal for Studies on Children, Women, Elderly and Disabled Persons. 2019. Vol 8 (Oct), 86-95. ISSN
0128-309X. Published online on 22 Jan 2020.
3
Lee Ai-Vuen, Pang Hoong-Chee, Sharon Linus-Lojikip, Wong Koh-Wei, Goh Kheng-Wee, Chan Fei-Sia. Pattern of Biopsy-
Proven Renal Disease in Sabah: A Retrospective Cross-Sectional Study Over 3.5 Years. Med J Malaysia. Vol 75 No 2 March
2020.
4
Tan, PP., Fauzi, HM., Bahar, R., Chang, CT., Abdul Rahim, NA. 2019. Knowledge and Perceptions of Blood Safety among
Blood Donors in Kelantan, Malaysia. Malays J Med Sci, 26(6): 127–136
5
Ang Ju Ying, Lai Jia Min, Amar-Sigh HSS, Ramalingam P, Ramasamy M, Zainuddin NS, et al., 2020. Awareness, perception
and experience on child restraint system (CRS) and its legislation among Malaysian parents with newborns. Traffic Inj Prev
[Internet];21(4):278–82. Available from: https://doi.org/10.1080/15389588.2020.1746773
6
Ang JY, Bhojwani K, Chan HK, Chan AC. 2020. A Malaysian retrospective study of acupuncture-assisted anesthesia in breast
lump excision. Acupunct Med.;0(0).
7
Kan FK, Tan CC, Von Bahr Greenwood T, Khalid KE, Supramaniam P, Hed Myrberg I, et al. 2020. Dengue Infection Compli-
cated by Hemophagocytic Lymphohistiocytosis: Experiences From 180 Patients With Severe Dengue. Clin Infect Dis.;70
(11):2247–55.
8
Lee, P. M., Chang, C. T., & Yusoff, Z. M. 2020. Adherence to tyrosine kinase inhibitors among adult chronic myeloid leuke-
mia patients in a Malaysia hospital. International Journal of Clinical Pharmacy. https://doi.org/10.1007/s11096-020-01070-9
9
Randhawa, A. S., Balasubramaniam, A., Rajan, P., & Mohamad, I., 2019. Migratory foreign body in the neck. Pediatria i
Medycyna Rodzinna, 15(4), 416–418. https://doi.org/10.15557/PiMR.2019.0072
10
Chang CT, Ying AJ, Woei WJ, Siew TS, Kuen CS, Beoy LA, et al., 2020. Bioequivalence and pharmacokinetic comparison of
two fixed dose combination of metformin/glibenclamide formulations in healthy subjects under fed condition. Med J Ma-
laysia.75(3):286–91
11
George, D., Chang C.T., Kumarasamy, K., & Ranga, A., 2020. One-Year Outcomes of Two-Week Double-Dose Clopidogrel
Treatment following Percutaneous Coronary Intervention in a State General Hospital in Malaysia. 16(May), 187–192.
12
Pravin Sugunan, Netia Jeganathan, Philip Rajan Devesahayam. Concealed Foreign Body Aspiration: A Master of Disguise.
Malaysian Journal of Peadiatrics and Child Health (MJPCH). Vol 26 (1) June 2020.
13
Ramneeta-Kaur Suarn-Singh, Shoen-Chuen Chiew, Suria Junus, Sheila Gopal-Krishnan, Murniyati Abd-Wahid, Winnie HC
Ng. Are Siblings of Children with Autism More Prone to Behavioural and Psychological Problems as Compared to the Gen-
eral Population? Malaysian Journal Of Psychiatry, June 2021, Vol. 30, No. 1. http://www.psychiatry-malaysia.org/article.php?
aid=2298
14
Yee-Ling Yeo, Chee-Tao Chang, Chii-Chii Chew, Shamini Rama. Contactless medicine lockers in outpatient pharmacy: A safe
dispensing system during the COVID-19 pandemic. Research in social and administrative pharmacy. https://
doi.org/10.1016/j.sapharm.2020.11.011
15
Bee Sim Chua, Li Herng Song, Chee Tao Chang, Xin Jie Lim, Jeyaseelan Nachiappan. Drive-through transcutaneous bilirubin
screening for neonatal jaundice: A safe & efficient system during the Covid-19 pandemic. Journal Paediatric Child Health
2020 Oct 19. https://doi: 10.1111/jpc.15226.
16
Tan PP, Chang CT, Sabariah MN. Blood supply management during the Covid-19 pandemic: Experience in a tertiary referral
hospital in Malaysia. Transfusion and Apheresis Science 2020 Oct 30;102982. https://doi: 10.1016/j.transci.2020.102982.
Hospital Raja Permaisuri Bainun
9
10. Hospital Raja Permaisuri Bainun
1st
Runner up winner for Oral Presentation,
Taiping Research Day 2020
Best Poster Award , 13th National Conference for Clinical Research (NCCR) 2020
1st
Runner up winner for Poster Award , 13th National Conference for Clinical Research
(NCCR) 2020
Acknowledgement as Bioequivalence Centre by
NPRA
10
11. Hospital Taiping
No. Published Article
1
Hussin,N., Lim,A.L., Goh,P.P., et.al., 2020. Updates on malaria incidence and profile in Malaysia from
2013-2017. Malaria Journal, 19-55
2
K.C. See, S.M. Liew, David C.E. Ng, E.L. Chew, E.M. Khoo, C.H. Sam, D. Sheena, Z. Zahilah Filzah, S.Y.
Chin, P.Y. Lee, L.P. Tan, Z. Farah Najwa, S. Sabrina, W.W. Them, T. Saipriya, Z.A. Muhammad Za-
makhshari, W.K. Cheah, K. Peariasamy, P.P. Goh, H. Ibrahim, 2020. COVID-19: Four Paediatric Cases
in Malaysia. International Journal of Infectious Diseases 94 (2020) 125–127
3
Hor C.P. , Narwani H. , Saravanaa N. ,Ooi W.T., Tang X.Y. , Sara Z. ,Singh G.P. , Rosilawati A.R.
,Kunaraj P. ,Cheah W.K. 2020. Experience of short-term hydroxychloroquine and azithromycin in
COVID-19 patients and effect on QTc trend. Journal of Infection , doi: https://doi.org/10.1016/
j.jinf.2020.05.058
4
Fann,R.J., Vidya,R.R., Chong, H.E., Vaithlingam, I., Christopher, C.W.S., 2020. Clinical presentations
and predictors of mortality for leptospirosis- A study from suburban area in Malaysia. Medical
Journal of Malaysia, Vol.5, No.1
5
Ambigapathy S, Rajahram GS, Shamsudin UK, Khoo EM, Cheah WK, Peariasamy KM,Goh PP, Khor
SK, 2020. How should front-line general practitioners use personal protective equipment (PPE)?
Malaysian Family Physician Volume 15, Number 1
6
Liew SM, Khoo EM, Cheah WK, Kalaiarasu P, Goh PP, Hishamshah MI. 2020. We have to write and
share valid and reliable information on Covid-19. Malaysian Family Physician; Volume 15, Number
1
7
Nurul Raihan A.K., Narwani H., Mohd Effendi M.G., Chung W.M. 2020. Meralgia Paresthetica - Im-
portance of Anatomical Knowledge in Diagnosis. Med & Health ; 15(1): 280-287
8
Sin Hong Chew, Irene Looi, Kar-Keong Neoh, Joshua Ooi, Wee-Kooi Cheah, Zariah Binti Abdul Aziz.
Clinical outcomes of acute stroke thrombolysis in neurologist and non-neurologist centres - A
comparative study in Malaysia. Accepted by Medical Journal of Malaysia on 5th December 2020.
11
12. Hospital Seri Manjung
No. Published Article
1
Tan TL, Lee LY, Yong KT, Rohimi MA, Chiew SC, Cheng SH, Mo-
hamed Haniba H, Ding MT, 2020. Pre-existing Chronic Medical
Illnesses and Follow Up Status among Active Pulmonary Tuber-
culosis Cases in a District Population. Med J Malaysia;75(3):204-
208.
2
Yeoh SL, Chiew SC, 2020. The prevalence and risk factors of vit-
amin B12 deficiency among patients with type 2 diabetes melli-
tus in a district of Manjung, Perak, Malaysia. e-PMJ;2(1).
3
Teh PN, Chiew SC, Gopal-Krishnan S, Yap EL, Yusof F, Abdul-
Manan R, Santhrasegaran M, Ismail R, Abdul Kadir H, 2020.
Comparison of two clinical case definitions in detecting over-
weight and obesity among registered nurses in a district spe-
cialist hospital. e-PMJ;2(1).
Certificate of Merit Dr. Wu Lien- Teh Young Investigator Award
12
13. Premaa Supramaniam, & Chew Chii Chii
Emphasizes
quantitative
analysis, followed
by interviews or
observation
(qualitative
measures) to as-
Explanatory Sequential Design
Exploratory Sequential Design
Qualitative data
collection and
analysis
contributes to the
design. Leads to a
more extensive
quantitative study.
Data collection and
analyses conducted
simultaneously for both
quantitative and
qualitative methods.
Results will be compared
to look for patterns or
contradictions.
Convergent Parallel Design
“Good, sound
research projects
begin with
straightforward,
uncomplicated
thoughts that
are easy to read
and
understand.”
13
14. *Some of these courses were conducted before the implementation of Covid-19 SOP
14
15. *Some of these courses were conducted before the implementation of Covid-19 SOP
15