A Unique Model to Accelerate Industry-sponsored Research in Malaysia – Journal for Clinical Studies

This article originally appeared in Volume 11, Issue 1 of the Journal for Clinical Studes.

The influx of industry-sponsored research (ISR) into the Asia Pacific region is continually growing due to the rising costs and complicated processes involved in drug development. Several countries within the region such as Singapore and, more notably, South Korea, have taken the initiative to develop and further strengthen their place as preferred destinations to conduct clinical trials. One such initiative is the establishment of specific entities that focus on nurturing and expanding the existing clinical trial ecosystem within the individual countries. With over 20 years of experience in conducting late-phase trials, the Malaysian government is no exception.

In the last six years, Malaysia has been steadily building a comprehensive and supportive clinical research ecosystem within the country. This includes the creation of Clinical Research Malaysia (CRM), a non-profit company wholly owned by the Ministry of Health (MOH).1 This review will present CRM as a unique business model, established to create a thriving and comprehensive ecosystem for ISRs in Malaysia and how this business model may be relevant and replicated in Asian countries that are looking to focus on attracting ISRs. Read more

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 BRCA1 and BRCA2 mutations 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 BRCA genetic testing and counselling is only available at specialised centres in Kuala Lumpur but most people live outside the capital.” Read more

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. Read more

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! Read more

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). Read more

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. Read more

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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