Mainstreaming May Improve Access to Ovarian Cancer Genetic Testing in Malaysia

By Ms. Yoon Sook Yee, Cancer Research Malaysia

Mainstreaming may improve access to ovarian cancer genetic testing inMalaysia and help identify mutation carriers who may benefit from risk management and targeted treatment, suggests preliminary results of the MaGiC Study presented at the ESMO Asia 2018 Congress.

“Screening for BRCA1and BRCA2mutations is recommended for all patients with non-mucinous ovarian cancer,” said lead author Ms Sook-Yee Yoon, Genetic Counsellor, Cancer Research Malaysia, Subang Jaya, Malaysia. “Genetic testing identifies mutation carriers and triggers appropriate risk management and treatment. In Malaysia BRCAgenetic testing and counselling is only available at specialised centres in Kuala Lumpur but most people live outside the capital.”

TheMainstreaming Genetic Counselling for Genetic Testing ofBRCA1andBRCA2in Ovarian Cancer Patients inMalaysia (MaGiC Study) was set up to: 1) assess the prevalence of germlineBRCA1andBRCA2mutations amongovarian cancer patients; 2) determine the feasibility of mainstreaming of genetic testing and counselling at local hospitals; and 3) examine the psychosocial impact of genetic testing in Malaysia.

The study was designed to recruit 800 ovarian cancer patients over a three-year period. Basic genetic counselling workshops were held for 60 non-genetic clinicians from 25 hospitals across Malaysia. Patients are counselled by a trained non-genetic clinician in their local hospital in a clinical programme led by Professor Yin Ling Woo, MaGiC’s lead clinician, or by a genetic counsellor or clinical geneticist in a programme led by Professor Meow Keong Thong, who is the lead clinical geneticist at specialised centres in Kuala Lumpur.

All blood samples are analysed for BRCAmutations by Cancer Research Malaysia, led by Dr Joanna Lim who is the diagnostic lead. Patients receive pre-test counselling, followed by test results and post-test counselling. After both pre-and post-test counselling they are interviewed by a study researcher over the telephone to assess feasibility and the psychosocial impact of the experience. Interviews are based on scales adapted for use in Malaysia, including the Genetic Counselling Satisfaction Scale, the Decisional Conflict Scale, the Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire, the Distress Thermometer, and the Cancer Worry Scale. Interview results are being compared between the two counselling processes.

Two years into the study 476 patients have been recruited, of whom 445 received genetic testing and 59 (13%) had BRCA mutations.

“Around 13% of those tested were BRCAmutation carriers which is quite similar to that found in other populations,” said Yoon. “We found carriers throughout the country and are working with local clinicians to establish protocols in local hospitals that have not managed patients with known BRCAmutations before, thus building capacity in multidisciplinary teams for high risk management of breast and ovarian cancer risk.

In terms of feasibility, patients in the local and specialised counselling arms were equally satisfied with the counselling they received. The local counselling arm has been recruiting patients more quickly than the specialised arm. Yoon said: “Patients seem to prefer local appointments, so if they are referred to another centre for genetic counselling, they seem less likely to attend.”

Read more contents from CRM Bulletin Issue 16. Download here!

Preliminary results show that the answers to the psychosocial surveys were similar between the two groups. Mostpatients were satisfied with their counselling experience, felt informed about their choices, and found it easy to decide to go ahead with genetic testing. Yoon said: “These are preliminary results but mainstreaming of genetic counselling in Malaysia may be a feasible model to improve access to genetic testing services or patients with ovarian cancer. If successful, this model could be adopted for other cancers and in other parts of Southeast Asia.”

“Cancer is still a taboo subject in Malaysia and there is a fatalistic attitude to hereditary conditions,” continued Yoon. “Genetic information can cause conflict in families and the data we are collecting on the psychosocial impact of genetic testing will provide insights into the psychosocial challenges. With this knowledge, we can focus on interventions to overcome these challenges.”

In addition, in the past, genetic testing in ovarian cancer was limited to a small number of patients with the aim of identifying relatives at risk. Now that there is a drug that can potentially treat cancer patients with BRCAmutations, genetic counselling and testing may be requested by many more patients with epithelial ovarian cancer. This may increase the number of patients who qualify for testing and specialised centres may become overloaded.

 

Hepatitis C Elimination Through Access to Diagnostics (Head-Start) Comes to Malaysia!

Q&A with Sonjelle Shilton, Project Manager for the HCV Programme

 

Sonjelle Shilton, Project Manager for the HCV Programme

I joined FIND in 2017, and took on the role of Project Manager for the Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) project earlier this year. The majority of my career has been in Africa, where I spent 10 years as the Director of Operations of a community-based health outreach organization, HardtHaven, in rural Ghana – which showed me how critical it is that public health interventions be collaboratively designed and implemented with rigorous and meaningful data capture. If you don’t measure it, you can’t see if it’s making an impact. I brought my experiences from Ghana to the monitoring and evaluation team at Gavi, the Vaccine Alliance, where I coordinated multi-country, multi-year, prospective full-country evaluations before joining FIND. I hold a Master of Global Public Health and the Global WACh Graduate Certificate in Integrated Health of Women, Adolescents and Children from the University of Washington, USA.

Can you tell us a little more about FIND? Why are diagnostics so important?

FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. It is astounding to see how often diagnostics do not exist, are inaccessible, or cost too much. This needs to change: not only do diagnostics tell patients what is wrong with them, they allow patients to be linked to the right treatment. Plus they are essential to a fully functional health system for many reasons, including surveillance to detect disease patterns and inform public health decisions. Diagnostics also play an important role in the research and development of drugs and vaccines.

 

What is the HEAD-Start project all about?

Hepatitis C is an emergency – 4 out of 5 people with the virus are unaware that they have it, and the mortality rate is rising. Diagnostics exist but they are generally limited to specialist laboratory use, and not getting to the people who need them. A complicating factor is that hepatitis C predominantly affects at-risk or marginalized populations, like people living with HIV, and those who inject drugs. Our HEAD-Start project, funded by Unitaid, is working to improve diagnosis of hepatitis C by simplifying the testing process and making diagnostics more affordable and more widely available. We’re aiming to generate data that will help to drive a change in global implementation guidelines and national policies in support of the World Health Organization elimination targets for 2030.

 

Malaysia has declared hepatitis C to be a national health priority. How is HEAD-Start contributing to Malaysia’s efforts to tackle this disease?

The Malaysian government is showing the world how to tackle hepatitis C – we believe Malaysia should be a model and source of inspiration that other countries in the region can look to as they scale up their own HCV responses. It was therefore really important for us to include Malaysia in HEAD-Start, and it is the only high-middle-income country covered by the project. Earlier this year we signed a Memorandum of Understanding with CRM to collaborate in the research and development of an innovative hepatitis C diagnostic testing strategy that we hope will lead to more cost efficient and earlier detection of hepatitis C.

 

Read more contents from CRM Bulletin Issue 16. Download here!

Can you elaborate on the diagnostic challenges for hepatitis C?

In many countries, including Malaysia, health services are largely centralized – which broadly speaking means diagnostic services for hepatitis C are available in hospitals or laboratories, but not at the primary care level or in community healthcare settings where people first access health services. HIV testing sites offer some of the most accessible testing services, and we believe that integrating hepatitis C diagnostics into this existing infrastructure could be a game-changer for reaching people with hepatitis C/HIV coinfections, in addition to those who inject drugs.

 

What does that mean in practice? How will you make tests available in primary healthcare settings and what will happen to those who get a positive diagnosis?

We are working to demonstrate the feasibility of using new, rapid diagnostic tests in decentralized primary healthcare facilities, and provide technical assistance to the Malaysian Ministry of Health for their implementation. This work is being conducted in partnership between FIND and the Drugs for Neglected Diseases initiative (DNDi). Both FIND and DNDi are product development and delivery partnership organizations, so it’s in our DNA to value collaboration on projects that facilitate equitable development along the entire care cascade. People who test positive for hepatitis C will be offered treatment in one of two ways. They can either join an ongoing DNDi clinical trial, which is co-sponsored by the Malaysian Ministry of Health and designed to assess the efficacy and safety of a new, alternative treatment regimen combining sofosbuvir with the investigational drug ravidasvir. Initial results from the first stage of this trial have indicated extremely high cure rates, including hard-to-treat cases. Alternatively, they will enter the Malaysian national hepatitis C programme, which now offers free treatment (sofosbuvir/daclatasvir) in 22 government hospitals.

Journey to success in Phase 1b Clinical Study for Hepatitis B at the University Malaya Medical Centre, Malaysia

By Chan Wei Quan, Site Manager, Global Clinical Operations (GCO) Malaysia, Janssen

Prof Rosmawati and her team, together with CIC and Janssen representatives.

If you were diagnosed with chronic hepatitis B, would you be willing to try an experimental compound developed by a world-renowned pharmaceutical company? On one hand, you may be hesitant but on the other, you may want to know more about it. For novel compounds to be approved for use in the market, pharmaceutical companies go through a period of pre-clinical and clinical phases to evaluate the compound’s effectiveness. To achieve this, volunteers are needed!

Based on statistics generated by Clinical Research Malaysia (CRM) on phases of clinical trials that were conducted in Malaysia for the year of 2017, Phase 3 studies topped the chart. Whereas for Phase 1 studies, a total of 5 Phase 1b studies were conducted in Malaysia. Is Malaysia too reserved in exploring Phase 1 studies? As a matter of fact, Malaysia has recently released a Phase 1 clinical guideline as well as a Phase 1-unit inspection and accreditation program. Malaysia is now one step closer to conducting more first-in-human (Phase 1) research. Thanks to the groups of regional key opinion leaders in initiating the Phase 1 realization project (P1RP), afflicted patients in Malaysia now have access to new treatment options and regimens. Furthermore, this allows room for economic growth as clinical research could be one of its main drivers as mentioned by the previous Malaysian Health Minister, Dr. Subramaniam. A little elaboration on what Phase 1 study is. Phase 1 study is to primarily to determine what dosage is safe and how treatment should be given. Dosage may be given in single ascending dose/multiple ascending dose. The target population is usually healthy volunteer and study is conducted in small scale. You may search for “Phase 1” to know more……

Chronic Hepatitis B (CHB) is one of the most alarming diseases that has captured the attention of the public health globally. One of the common infections by the hepatitis virus, CHB is often linked with major psychosocial issues due to social stigma. In Malaysia, a multicultural country in Asia, the CHB carries rate varies depending on ethnicity and gender. According to Raihan R (2016), CHB accounts for more than 80% of the hepatocellular carcinoma (HCC) cases seen in Malaysia, and HCC is the third most common type of malignant neoplasm and among the top ten leading causes of death. Following the implementation of the nationwide hepatitis B vaccination in 1989, there was a steady decline of CHB. There is currently no cure to hepatitis B and CHB patients require a daily medication regimen to suppress the hepatitis B viral load. This duration of this regimen is indefinite with the risk of patients developing side effects over the long run. There is an unmet medical need to a CHB cure and this has been the central focus of many pharmaceutical companies. There are several pharmaceutical companies working to develop a cure for CHB. Any of these companies wanting to conduct a trial in Malaysia would know that Prof Dr. Rosmawati Mohamed is a leading key opinion leader in this field.

L-R: Prof Dr Rosmawati awarded the “Top recruiter In Asia – Phase 1b: Session XI” and Dr Syed Mukhtar awarded with certificate of appreciation in ensuring study quality.

While managing the Phase 1b trial (namely HPB1001) clinical study in Malaysia, I had the privilege of working with a renowned hepatologist from the University Malaya Medical Centre (UMMC), Prof. Rosmawati Mohamed. The novel compound may or may not confer therapeutic benefits to the patient, however, the eagerness to look for a functional cure and to improve CHB patients’ quality of life for Prof Rosmawati prevailed. Prof Rosmawati as the principal investigator (PI) headed a team comprising Dr. Roma Basu and Dr. Abdul Malik (sub-investigators), in addition to Dr. Syed Mukhtar and Dr. Zainab Abu Kassim (study coordinators). During this time, Prof. Rosmawati and her team dedicated valuable time and effort in screening for suitable patients. Patients needed to be diagnosed with CHB, but also had to be relatively well in terms of medical health. Furthermore, patients needed adhere to protocol procedures and restrictions while being compliant to prohibited and allowed concomitant medications. At the end of the recruitment period, Prof Rosmawati and her team managed to recruit five patients into the HPB1001 study, ranking Malaysia as the second-best recruiter globally, and ahead of a few countries known for well-established Phase 1 experiences. This achievement puts Malaysia in the limelight as a rising competitive country in conducting Phase 1b trials, despite being initially considered naïve country in Phase 1 studies.

Clinical trials are unable to commence without the approval from a local ethics committee (EC). Moreover, clinical trial proposals submitted to the EC may sometimes warrant justification from the PI on the risk-benefit assessment for conducting such a clinical trial (termed a EC defense meeting). The HPB2001 trial was one of the proposals requiring further clarification, for which Prof. Rosmawati defended excellently. Her effort in defending the proposal during the meeting ensured that the study was approved by the EC on time, allowing for country and global milestones to be met.

Another important aspect of clinical trials is the generation of quality data. Data is collected each time the patient makes a visit to the hospital. This data is compiled and analyzed on a global level, allowing further adjustments to protocols as required. This data is eventually required for the submission to the health authorities for drug approval and marketing. For the HPB2001 trial, Pros. Rosmawati showed great perseverance in ensuring the timely entry of patient data as well as implementing effective retention strategies for the patient during the three-month study period. Prof. Rosmawati managed to retain all of her enrolled patients in the HPB2001 clinical study, symbolizing a mark of excellence.

Read more contents from CRM Bulletin Issue 16. Download here!

In this highly regulated industry, subject safety, data integrity and quality are of the utmost importance. In August 2018, the Malaysia Health Authorities, the National Pharmaceutical Regulatory Agency (NPRA) conducted a three-day inspection for the HPB1001 at UMMC. The outcome was favorable with no major findings or observations noted. The results of this inspection are not only a reflection of Prof. Rosmawati’s dedication to conducting the HPB2001 trial but is also a form of favorable validation on the quality of the research. Furthermore, the success of the inspection is also attributed to the Clinical Investigation Centre (CIC), a clinical department at UMMC dedicated to conducting clinical trials.

Clinical research is a necessary step in sourcing alternative treatment options to many diseases. CHB is one of these diseases. The success of clinical research is largely dependent on the clinical study team chosen to manage it. However, aside from the study team, an even more pivotal element in ensuring the success of clinical trials are the patients. Patients who join the trials allow the generation of data, which in turns leads to more data contributing to the approval of the drug and eventually its availability to the community, hence bringing more benefit to more patients. The willingness of patients who volunteer in the early drug development phase is deserving of commending respect, despite the limited safety and efficacy data generated from pre-clinical studies. Their commitment to clinical trials is regarded as a major contribution in accelerating the development and approval of experimental treatment options. The “I AM AWARE” campaign, designed to increase awareness of clinical research in Malaysia is currently underway. These campaigns conduct regular roadshows at government hospitals and also happen to be a good source of information pertaining to clinical research.


Reference:
Raihan R. Hepatitis in Malaysia: Past, Present, and Future. Euroasian J Hepato-Gastroenterol 2016;6(1):52-55

Hospital Raja Perempuan Zainab II

Hospital Kota Bharu was established in the 1920s. In remembrance of the late Sultanah Kelantan, this tertiary care facility name was changed to Hospital Raja Perempuan Zainab II (HRPZII) and the ceremony was officiated by Kebawah Duli Yang Maha Mulia Al-Sultan Kelantan Tuanku Ismail Petra Ibni Almarhum Sultan Yahya Petra on 5 September 2005.  HRPZII is the main referral centre for the entire state of Kelantan and Northern District of  Terengganu. The undergraduate medical students from University Sains Malaysia (USM) and Post Graduate Distance Learning Program (PJJ) doctors use HRPZII for their practical training, as well as trainees preparing for examination conducted by Universiti Kebangsaan Malaysia (UKM), USM and professional bodies overseas. Basic and post basic training for paramedical personnel and are conducted as in-service training for all categories of staff. In addition, HRPZII was recently appointed as a Regional Hub for Telemedicine, Regional Referral Centre for Psychiatry service and Regional Clinical Research Centre (CRC).

SPECIALTY

  • Accident & emergency
  • Anesthesiology
  • Dermatology
  • Forensic
  • Medical
  • Nephrology
  • Obstetrics & Gynaecology (O&G)
  • Ophthalmology
  • Oral surgery
  • Orthopaedic
  • Otorhinolaryngology
  • Pathology
  • Pediatric
  • Psychiatry
  • Radiology
  • Rehabilitation
  • Surgical

 

Evolution of CRC Kelantan

2002

  • CRC Hospital Kota Bharu created and operated as one of the quality activities at hospital level.

2007

  • Renamed to CRC Kelantan and has expanded its scope of services to state level.
  • Operates as an independent unit and is listed among other units and departments at HRPZII.

2013

  • CRM SC joins in as part of CRC Kelantan.
  • Officially selected as 1 out of 11 IQVIA (previously known as Quintiles) Prime Sites.

2015

  • CRC Kelantan office relocated to hospital staff quarters.
  • Comprises of 2 treatment rooms/clinics and research room used to conduct Industry Sponsored Research (ISR) and Investigator Initiated Research (IIR).

2017

  • Addition of CRC office space, SIV/monitoring room, Head of Unit room, staffroom,   record room and tutorial room.

2018

  • Officially selected as PARAXEL Preferred Site.

Total  staff : 19
Specialist : 2
Medical officer : 2
Pharmacist : 1
Research officer : 1
Nurse : 2
Administrative officer : 1
Contract Officer : 1
CRM Study Coordinator : 7
Freelance Study Coordinator : 2

 

Services

Consultation

  • NMRR online registration
  • Protocol & proposal development
  • Literature search / review
  • Review of Research Protocol for IIR
  • Statistical consultation
  • Manuscript and abstract write up
  • Assist in submission of research papers
  • Assist in grant application

Training

  • Good Clinical Practice (GCP)
  • Introduction to Clinical Research (ICR) Workshop
  • Statistical Analysis Workshop
  • Study Coordinator Workshop
  • Research Methodology Workshop
  • Scientific Writing Workshop
  • East Coast Research Camp
  • Other research related courses

 

Facilities

START UP TIMELINES, METRICS, QUALITY AND ACHIEVEMENTS

Average Days

Start-Up timelines: <75 days
Quality: 94.8% (IQVIA Spotfire 19thOct 2018)
SIV to FPFV: <60 Days
Contract Executed timelines: 30 days

 

Read more contents from CRM Bulletin Issue 16. Download here!

Standard Operating Procedures (SOP)

  • Availability of CRM SOPs at site enable site to use it as reference/guide for the conduct of clinical trial.
  • Each CRM SCs are certified, and they can train other hospital site staff on the proper conduct of clinical trial.

 

IQVIA Prime Site

  • Hospital Raja Perempuan Zainab II was selected as one of the 11 Prime Site in Malaysia in 2013.
  • This partnership enables to benchmark Malaysia with other global countries for these contributing factors; increase number of clinical trial, improve start up timeline, High quality and meet/exceed patient recruitment targets.

 

PAREXEL Preferred Site

  • Officially selected as PAREXEL Preferred Site on 21stNov 2018.
  • Objective: to outline the preferred site strategy, better understand site’s areas of therapeutic interest, capabilities, capacity and infrastructure and explore whether there are areas of mutual interest.
  • Ultimately, if both parties felt there was a desire for, and benefit in, a more strategic collaboration, PAREXEL would work with site’s leadership team to increase the flow of clinical trial opportunities to site, identity a relationship manager within PAREXEL to oversee the collaboration and agree how best to optimise communication and processes between the two parties.

HRPZII awarded for Highest Number of Newly Approved Endocrinology Clinical Trials in Year 2016.

 

CRM has successfully achieved the accreditation for ISO 9001: 2015.

 

Research Personality: Dato’ Dr Mahiran Mustafa

I started my career as a House Officer (HO) at Hospital Universiti Sains Malaysia (HUSM) after I graduated from the University Hospital of Wales, United Kingdom in 1987. Later, I joined a master program in Internal Medicine at HUSM and was subsequently qualified as a physician in the year 1993.

In 1993, I was posted at Hospital Raja Perempuan Zainab II (HRPZ II), Kota Bahru as a physician. Later in 2001-2003, I joined as a trainee in the field of Infectious Disease and was attached at Hospital Kuala Lumpur and Newcastle upon Tyne Hospital in the United Kingdom. During this training period, I did a lot of clinical audits and clinical studies and had successfully submitted for a poster publication in United Kingdom and Europe. In 2011, I did a short attachment at the Hospital of Infectious Control at Glasgow Hospital in Scotland.

Currently, I am actively involved as a coordinator for Technical Working Group for National Antimicrobial Action Plan. I am also the Chairperson for Clinical Practice Guidelines: Management of Dengue Infection in Adults where we train health providers on dengue management. Apart from that, I work as a State Physician in Kelantan as well as a coordinator for my Hospital Infection and Antibiotic Control. I carry out many more tasks at the national level as a committee member and continue to serve as a consultant for Infectious Disease.

 

Can you tell us when and how did you first got involved in clinical research?

I started to be interested in clinical research during my master’s degree training at HUSM. After I qualified as a physician, I started to be involved in pharma-drug trials from 1997 and continue to actively involve as a supervisor for postgraduate Internal Medical candidates in their research projects.

When I was the Head of Medical Department in HRPZ II from 2011 till 2017, I realised that having a strong research team was our asset to participate in international clinical research and be recognised as a centre of clinical trials. I took this opportunity to start training my junior specialists and paramedics by sending them to GCP courses conducted by CRC. As the Head of Department (HOD), I kept encouraging specialists to participate as investigator and our goal at that time was that each specialist to conduct or participate in two clinical trials.

As for my team, we have completed at least 10 trials and currently another 4 trials have been approved and are due to start in December 2018 and January 2019.

Based on the number of trials and appraisal by sponsors, we are very proud that our department is recognised as one of the leaders in clinical trials at hospital or ministry level.

 

How has clinical trials change your practice and management of patient care?

Often, I use the experiences I have gained in clinical trials to improve my own way of practicing medicine during my clinical work. I have become even more particular in documenting clinical history and signs, more particular in providing options on treatments to patients and more respecting of their choices.

Clinical research helps me to understand the need to do more research in clinical areas in order to have a better treatment options for both acute management and chronic diseases. The best drug today for disease treatment may not be the best treatment in 10 years time as there would potentially be a drug that is safer and has more efficacy than the current best.

No new clinical science discovery means the end of new drug development. Most clinical questions can be answered only from good and high-quality research either for drugs or intervention. So, most of the time you will look at current research in the journal publications in order to find answers. I do that most of the time.

 

What are the main challenges you encounter when conducting a clinical trial and how do you overcome them?

To have a good and experienced team to do research is one of the main challenges. I would not be able to do everything on my own. Most of us feel that our official clinical duty is already too much of a burden. I try to overcome this by getting them interested in clinical research; I invest on creating highly skilled co-investigators and research assistants by providing them quality training and opportunities. Currently, I have at least 10 of them on my team that are willing to participate in conducting clinical trials. We work closely together and have specific roles delegated when there are ongoing clinical trials. Clinical Research Center (CRC) and Clinical Research Malaysia (CRM) have provide amazing access to the training which should not be wasted and ignored.

It can be stressful to manage the limited time and the high work load we have. Hence, we need to organize our work and create time and space for it. Pre-screening the subjects helps the trials to run smoothly and enables us to achieve our target much easier. I also feel that the involvement in research provide an opportunity for me to do something I like and enjoy. I believe this can be considered as part of my productivity to Ministry of Health of Malaysia to be part of the research landscape. As I believe,productivity is about “knowing what you want to do, intending to do it, doing what you wanted to do and see the results”.

 

Read more contents from CRM Bulletin Issue 16. Download here!

What is your motivation behind conducting clinical trials?

The answer is PASSION and INTEREST. Often, I use research as a platform to provide an option to treat patients who are no longer on treatment or has access to new treatment.

 

What one word best describes your career as a clinical researcher / investigator? Why?

Satisfaction. Once a research has been completed, I felt like I have proven to myself that I have reached my goal that was set at the beginning of the research involvement. I want to set an example to junior doctors that as clinicians, we can still become a clinical researcher and play an important role to actively participate in clinical research.

In the field of clinical research, where do you wish to see Malaysia in the next 10 years?

As one of the main players that provides high quality research centres and investigators globally. CRC and CRM are 2 important bodies that will enhance and bring more research to our country.

 

What changes would you like to see being made by the policy makers to create a more conducive ecosystem for the conduct of clinical trials in Malaysia?

For clinicians who are interested to do research – especially for investigator-initiated research – a specific/protected time should also be allocated to them to carry out the research and do the write up for journal publications. This should be for both investigator and industry-sponsored clinical trials. Investigators with successful publication at international congress or high impact journal should be given some incentives in form educational grant.

Hospital Sultanah Bahiyah

Hospital Sultanah Bahiyah (HSB) officially operated at its new building complex on 29 July 2007 after a complete transfer and replacing Hospital Alor Setar. Located 6 km from the centre of Alor Setar City, and within the sight of the PLUS North-South Highway, its location makes Hospital Sultanah Bahiyah easily accessible to the public. Surrounded by a vast area of paddy fields, this building complex incorporates 4 main buildings, namely the Medical Support Block, Ward Block, Main Block and Non-Medical Support Block. Read more

Research Personality: Dr. Toh Teck Hock

Before I joined Sibu Hospital, I have worked in the United Kingdom, Singapore and Australia for a number of years as a paediatric trainee. Besides general paediatrics, I also work in the areas of developmental-behavioural paediatrics and community child health. I am an Adjunct Professor for SEGi University Medical School as well as the Special Olympics Asia Pacific Regional Clinical Advisor in Health Promotion®, Vice President for the National Early Childhood Intervention Council, Council Member for Sarawak State Council for Early Childhood Education and Development, National Assessor for the Baby-Friendly Hospital Initiative and Secretary of the Association for Children with Special Needs Sibu. Besides scientific papers, I have also published parent-teacher handbooks on ADHD, language development and breastfeeding, as well as children reading / colouring books, and books on Chinese literary prose/short stories. I received The Outstanding Young Malaysian Award in 2010, and Special Education Network in Asia Advocacy Award in 2018.

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DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

According to the DiabCare 2013, despite the effort in improving diabetes care in Malaysia, glycemic control and the prevalence of many diabetes related complications were unchanged over the years.There is still an inertia in getting the patients to clinical targets early with the right treatment.  In view that global real-world data on the management of type 2 diabetes (T2D) are limited, the global DISCOVER study was initiated with the primary objective of describing disease management patterns and disease evolution over 3 years in patients with type 2 diabetes initiating a second-line glucose-lowering therapy.2

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Evolution of Clinical Trial Agreement Review in Malaysia Through CRM

To regulate the conduct, relationships, responsibilities, and obligations of the parties involved in the clinical trial, the Clinical Trial Agreement (CTA) must be in place. The parties in a CTA are not usually limited to sponsors or contract research organizations (CROs), but also include institutions and principal investigators. The Malaysian Guideline for Good Clinical Practice, has defined the CTA as“A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.”(1)

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Where Are Clinical Trials Studies? – SIN CHEW DAILY (Translated)

Where Are Clinical Studies?
Check Online to Find Out 

“In October last year, Clinical Research Malaysia added a brand-new function to its official website http://www.clinicalresearch.my/. It is a prominent column in the lower right corner of the web page, with the tab “Find a Clinical Trial”. This new function brought good news to critically ill patients, especially those unable to afford expensive medical treatments. Patients and their families can find out which government or private hospitals provide new research or treatment options according to their medical conditions. 

Syed Hamzah -Business Development Executive, Clinical Research Malaysia (CRM)

In the website, the users can select between “Healthy Volunteer” or “Patient” and proceed to fill in their personal information to register themselves. Based on the information provided in the website, for “Healthy Volunteers”, they can choose Ampang Hospital in Selangor, three different hospitals in Penang and a hospital located in Kuching. For “Patients”, the diagnosis of illness and their location must be filled in order to search for the appropriate hospital. The participating hospitals in this clinical trial cover all parts in Malaysia, which include hospitals in major cities, as well as several large private hospitals. 

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