Recruitment is everything in a trial!

By Soon Wen Xian, a medical graduate from Volgograd State Medical University, a Clinical Research Associate at an international pharmaceutical organization based in Singapore.

There are many stages in a clinical trial, for example: feasibility study, start up, active recruitment stage, maintenance stage and study closure. Each stage of a trial is important, but the recruitment process is undeniably the most important part. Because if there is no patient being recruited, there will be no data to analyse and without data, the trial will not meet any objectives. That is why recruitment process plays a very important role in ensuring a successful clinical trial. Recruitment rate is almost always the main issue in a trial. If we can speed up the recruitment rate, not only would we have the results faster, we would also be able to reduce the cost of the trial. In order to make recruitment process a successful one, both site member and sponsor must know their roles well. For this issue, I would like to share how we can make a trial recruitment process easier, faster, and more effective. 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

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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