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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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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Kuala Lumpur Sports Medicine Centre (KLSMC) On Stem Cells Research And Therapy

Read more contents from CRM Bulletin Issue 13. Download here!

Articular Cartilage Repair and Regeneration

Articular cartilage is the soft tissues that surround the bones in the knee joint enabling smooth movement of the knee. Anyone who has suffered or is suffering from damaged cartilage will know just how painful it can be. This can also seriously impact their quality of life and daily function. Regeneration of damaged cartilage has long been thought impossible due to the nature of its tissues. The conventional way of treating cartilage damage often involves complex surgery and is limited to small areas. Even so, the success rates were variable and inconsistent. Often the treatments result in the formation of scar tissues, which cause the cartilage to breakdown faster than normal healthy cartilage; and eventually lead to revision of surgery, higher medical care cost, and little to no improvement in quality of life.

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My Personal Experience in Conducting Trials in Sabah and Sarawak

By Soon Wen Xian

Soon Wen Xian, a medical graduate of Volgograd State Medical University, is currently a Clinical Research Associate at an international pharmaceutical organization based in Malaysia.


When I was a young boy, Sabah and Sarawak have always had an air of mystery about it. Despite both being the largest and second largest state in Malaysia, I never had a chance to visit them. And that was until I joined the clinical research industry.

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CRM’s Quality Improvement Plan

At clinical research sites, Standard Operating Procedures (SOPs) help define the study team standard practices and daily processes to assure execution of study tasks are in accordance with the requirements. SOPs should contain enough detail to guide the study team through a particular procedure and thereby establish uniformity in the everyday functions of each site.

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Esketamine Trial – A Success Story in Patient Recruitment

Written by Chan Wei Quan, Site Manager at Janssen

 

Of all the illnesses out there today, which one would you say is the leading cause of disability around the globe? The answer may surprise you.

It’s depression, which affects more than 15 million adults in the U.S. and more than 300 million worldwide, according to the World Health Organization (WHO). It can cause the affected person to suffer greatly and function poorly at work, at school and in the family. At its worst, depression can lead to suicide. Close to 800 000 people die due to suicide every year.

All existing antidepressants work on the same premise by increasing the brain levels of serotonin and/or norepinephrine—neurotransmitters. However, only about half of the patients receive an adequate response from them, which typically takes four to eight weeks or longer for someone to start feeling better. When you are that depressed and possibly on the point of contemplating suicide, 4 to 8 weeks is a long time….

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