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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Clinical Research Centre (CRC) Hospital Sultan Ismail, Johor Bahru

Hospital Sultan Ismail Johor Bahru (HSIJB) began fully operational in May 2006 and was the second hospital in Malaysia that has started using the electronic system Total Hospital Information System (THIS). It currently has 18 specialists services with 21 subspecialties. HSIJB is a tertiary specialist hospital that is the main oncology centre in the southern region of Malaysia. Besides having a paediatric palliative care centre, it also has its own Clinical Research Centre (CRC) that supports both Industry Sponsored Research (ISR) as well as Investigator Initiated Research (IIR).

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Have I Done Enough? – Recruitment and Retention

Read more contents from CRM Bulletin Issue 14. Download here!

The success or failure of a trial strongly lies in the recruitment achievements.  Although clinical trials has been conducted in more than few decades, the recruitment continues to be an immerse challenge for most trials. Investigators enthusiasm for ambitious recruitment targets is often misguided. This is called as “Lasagna Law” where by, investigators overestimate the pool of available patients and at the end of the study fails to deliver the promised target.

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Unraveling the Methodology of Risk Based Monitoring

Read more contents from CRM Bulletin Issue 14. Download here!

The growth of clinical research is extraordinary and the number of clinical trials being approved to run is increasing rapidly in the world. Therefore, there is an increase in the complexity of newer trials as well as the cost of monitoring them. This increasing complexity leads to clinical sites generating more errors during data collection, thus causing delays in the data-cleaning process. Furthermore, there is a higher chance for deviations to occur and be unnoticed at a clinical site. These deviations may directly affect patient safety and data integrity, and is in violation of Good Clinical Practice (GCP). Considering this development, most pharmaceutical companies (or sponsors) are moving towards a new monitoring approach called the Risk-Based Monitoring (RBM) model. For RBM to be defined, a comparative analysis needs to be made between RBM and the traditional monitoring model.

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Site Selection – What a Sponsor Looks For?

Read more contents from CRM Bulletin Issue 14. Download here!

Clinical research is a process that studies a new treatment effectiveness. While it is a very good opportunity for doctors to study the disease development and treatment, the conduct of clinical research by doctors themselves requires a huge budget. Industry Sponsored Research (ISR) provides a good opportunity for doctors to be involved in new and ground-breaking research that may potentially change the course of treatment globally. The number of clinical research has been increasing over the past 10 years. Almost 50% of all trials registered in clinicaltrial.gov showed that it is conducted in Asia. However, less than 1% of the registered clinical research came to Malaysia. To increase the number of ISR in Malaysia, feasibility process plays an important role.

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Malaysia Spearheads Stem Cell Research

Read more contents from CRM Bulletin Issue 14. Download here!

The Ministry of Health (MOH) Ampang Hospital is embarking on a pioneering stem cell research exploring the use of mesenchymal stem cells (MSCs) in acute graft-versus-host-disease (aGVHD). While this innovative treatment has already been approved in several countries, it has so far only been used as salvage therapy after failing steroids and other immunosuppresants, and rarely employed as a front-line therapy. Steroid refractory aGVHD has a dismal prognosis with mortality in excess of 90% and no viable second-line options.1Working in collaboration with Cytopeutics®, a local company with an impressive track record of basic and clinical trials in stem cell, this Phase I-II double blind randomized clinical trial has been approved by the Medical Research Ethics Committee (MREC) and the National Stem Cell Ethics and Research Sub-committee (NSCERT). More centres are expected to participate in the trial locally and abroad including Singapore and Australia. The success of the treatment will provide a real chance of the patient surviving against the odds as well as put Malaysia on the map in the field of stem cell advances.

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