CRM Bulletin Issue 15: “Celebrating Clinical Trials” is out!

 

From CEO’s Desk

It is always an exciting time as we progress into the third quarter of each year because it is during this phase that we can see most of our efforts blossom into something of significance. At this juncture also, I would like to take this opportunity to highlight the fantastic achievements of our doctors in driving more high-quality clinical trials here in Malaysia. In recognising their contributions, we have held our annual Clinical Trials Day where we awarded them with the CRM Industry Sponsored Research Award – an award given to high achievers in clinical trials in Malaysia. We hope that with such awards, more people will step up their game in their respective fields.

As CRM is growing at a rapid pace, we recognise the importance of forging partnerships with global entities that are paving the way for better healthcare. To begin with, we have the National University Hospital Singapore (NUHS) team visiting the Director-General of Health, Datuk Dr. Noor Hisham in Malaysia. NUHS has also shown a strong interest to collaborate with Malaysia in clinical research and training. With this, we have reached another important milestone in our Phase 1 Realization Project. Next – with amazing help from our South Korean counterpart, C&R Research Inc. – the CRM team together with Datuk Dr. Noor Hisham went for a series of business networking meetings in Seoul. During the visit, we took the opportunity to promote Malaysia’s clinical research capabilities to the pharmaceutical companies in Korea in a bid to encourage them to conduct clinical trials here in Malaysia. I truly believe that by building trust with our current partners and expanding trust to our future partners, we will be able to position Malaysia as the site for sponsored research in this region.

As our faithful readers might know, one of our aims at CRM is to become a truly global research organisation. In line with our core values of Transparency, Honesty, Accountability & Trustworthiness, we strive to achieve the highest standards in the way we conduct our business.  As such, we are currently at the final phases of obtaining the ISO 9001:2015 accreditation, which we work very hard to obtain since last year. Being accredited with ISO 9001: 2015 will demonstrate the quality of management we are practicing within CRM and the consistent standard quality of clinical trials that are being conducted at all sites in Malaysia. We hope to achieve and obtain this accreditation by early 2019.

Finally, I would like to also take this opportunity to thank all of our people in CRM for striving hard in making the organisation a strong force it is today. For our readers, I hope you will enjoy reading this bulletin and will gain more insight on what we do, the kind of activities we conduct and most importantly, appreciate the efforts the whole community is putting in to make our world a better place to live in.

Dr. Akhmal Yusof
CEO, Clinical Research Malaysia

 

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) Read more

Embracing Digital Health

L-R: YBrs. Dr. Kalaiarasu M. Periasamy, Deputy Director, National Clinical Research Centre, Y.Bhg. Datuk Dr. Shahnaz Murad, Deputy General-Director of Health Malaysia (Research & Technical Support), YB. Dr. Lee Boon Chye, Deputy Minister of Health, YBrs. Dr. Akhmal Yusof, CEO of Clinical Research Malaysia, YBhg. Dato’ Dr. Goh Pik Pin, Director National Clinical Research Malaysia

KUALA LUMPUR, 24 September 2018 – The 12thNational Conference for Clinical Research (NCCR) brought together medical experts and researchers under one platform to understand the way digital technology can impact the Malaysian healthcare delivery system, thus potentially improving patient outcomes.

Annually held, the 12thNCCR showcased a rich and varied programme, with 20 renowned speakers from Malaysia, Singapore, China, Australia and the US. This year’s conference themed “Patient Centred Research – Digital Health” received more than 130 abstracts. The two-day conference was held at Hotel Istana and was officiated by the Deputy Minister of Health, Yang Berhormat Dr. Lee Boon Chye.

Dr. Lee Boon Chye, Deputy Minister of Health, Malaysia

“The digital transformation and revolution in health including embracing Industry Revolution 4.0 pose multiple challenges and we need to formalize strategies to progress ahead. These includes evidence, advocacy, ethics, policy and clinical practice. Evidence based medicine is the foundation in which delivery of healthcare rests on. Therefore, clinical research needs to expand to embark into translational research to ensure that the practical applications of digitalised healthcare provide relevant, effective and safe patient care,” said Dr. Lee Boon Chye.

The conference also provided an opportunity for local and international contract research organizations, pharmaceuticals and biotechnology and medical device companies to showcase and exhibit their products and services at various exhibition booths set up within the parameter of the conference area. The booths were flooded with delegates comprising of speakers, researchers, pharmacists, members of academia and clinical industry professionals during the two-day event.

CRC Named Lecture: Dato’ Dr. Amar Singh HSS

One of the conference’s highlight was the CRC Named Lecture which was delivered by Dato’ Dr. Amar Singh HSS, a senior consultant Pediatrician & Researcher and the former CRC Head of Raja Permaisuri Bainun Hospital, Malaysia.

More info on NCCR 2018, please visit www.nccrconference.com.my

Event Photos

Malaysia conducts clinical trials to improve patient survival

PUTRAJAYA, Sept 5 (Bernama) – Around 850 oncology and therapeutics clinical trials are conducted in Malaysia per year to improve patient survival, said Health Ministry (research and technical support) deputy director-general, Datuk Dr Shahnaz Murad.

Read more

Lee Wei Xin received CRM Education Scholarship

PETALING JAYA, 7 September 2018 – Clinical Research Malaysia (CRM) had the signing of CRM Education Scholarship Agreement between CRM and National Pharmaceutical Regulatory Agency – NPRA​ officer, Ms. Lee Wei Xin, signing witness on behalf of NPRA was Mr. Tan Ann Ling (Director of Enforcement Division) for the Phase I Realization Project (P1RP) earlier today.

Ms. Lee Wei Xin has been selected to receive a scholarship to further study Masters of Science in Clinical Pharmacology at the King’s College London, UK.

The signing was witnessed by Dr. Noraida Mohamad Zainoor (Senior Principal Assistant Director, NPRA), Ms. Zaleha Yusof (Head of Human Resource), Ms. Joanne Yeoh (Head of Clinical Operations) and Mr. Yau Yit Huan (Head of Finance and IT).

#CRMEducationScholarship #scholarship #advancingclinicalresearch #P1RP #askusaboutclincialtrials #NPRA

CRM ISR AWARDS 2018

We would like to congratulate 2018 ISR Award winners!

 

For highest number clinical trials with trial site activation & recruitment number for year 2017.

 

For consistent performance in patient recruitment for clinical trials initiated in Malaysia for year 2017.

For consistent performance in patient recruitment for clinical trials initiated in Malaysia for year 2017.

For outstanding achievement as principal investigator in clinical trials for year 2017.

For outstanding achievement in being among top oncology trial sites in Malaysia for year 2017.

 

Celebrating Clinical Research Through the Clinical Trials Day 2018 & 2nd IKN Research Day

PUTRAJAYA, 5 September 2018 – Clinical Trials Day 2018 was held at the Institut Kanser Negara (IKN), its second time since its initiation last year, to celebrate patients, volunteers and medical professionals involved in clinical trials. Clinical Research Malaysia (CRM) partnered with Clinical Research Centre (CRC) and IKN to organise this momentous event in conjunction of IKN’s 5th anniversary.

This event was well attended by all stakeholders in the clinical research industry. Various talks by prominent research personalities and patient support talks were organised for the general public as well as for the medical personnel to raise awareness on the importance of clinical trials.

At the event, a CRM Industry Sponsored Research Award was given to high achievers in clinical trials here in Malaysia to recognize their contribution in industry sponsored research, as well as to spur and encourage more of such efforts. IQVIA™ Malaysia received the CRO of the Year Award for highest number clinical trials with trial site activation & recruitment number for the year 2017, Dr Shereen Ch’ng Suyin (Hospital Selayang) and Dr Wong Yoke Fui (IKN) received  the Top Recruiter Award for consistent performance in patient recruitment for clinical trials initiated in Malaysia for year 2017, Dr Voon Pei Jye (Sarawak General Hospital) received the Investigator of the Year Award for outstanding achievement as principal investigator in clinical trials for year 2017 and Institut Kanser Negara received the Clinical Trial Site of the Year Award for outstanding achievement in being among the top oncology trial site in Malaysia for year 2017.

The event was officiated by the Deputy Director-General of Health (Research & Technical Support), YBhg. Datuk Dr. Shahnaz Murad. Also present was the Director of Institut Kanser Negara, YBrs. Dr. Asmayani, CEO of CRM, Dr. Akhmal Yusof & the Deputy Director of CRC National, YBrs. Dr. Kalairasu Periasamy.

About “I AM AWARE” Campaign

The “I Am Aware” campaign is a public education programme about the importance of clinical trials. The campaign is initiated to promote understanding of the true benefits and risks of participation of clinical trials and to provide resources to help individuals make informed decisions about research involvement. Hence, we have organised activities such as roadshow to various public health clinics and public hospitals in Malaysia.

View more photos via our Facebook Page below:

Simpler diagnostic Hepatitis C test at government facilities – BERNAMA

PUTRAJAYA, Aug 6 (Bernama) — A simpler diagnostic test for Hepatitis C will be made available at 22 government hospitals and 25 health clinics nationwide, said Health Minister Dr Dzulkefly Ahmad.

This follow the signing of memorandum of understanding (MoU) between the Health Ministry’s Clinical Research Malaysia (CRM) and Foundation for Innovative New Diagnostics (Find) which he witnessed here today.

Dr Dzulkefly said the MoU marked an important milestone in achieving  the World Health Organisation viral hepatitis goals, which is to get 90 per cent of the population screened and diagnosed and 80 per cent treated by the year 2030.

He said the Health Ministry estimated about 500,000 Malaysians were living with Hepatitis C infection today without even knowing it due to the low level of awareness.

“Lack of awareness on Hepatitis C  needs to be addressed accordingly as undiagnosed  Hepatitis C could result in liver cancer and other serious illnesses,” he said at the MoU signing ceremony.

Dr Dzulkefly said the Health Ministry would conduct Hepatitis C  outreach and awareness activities in order to encourage the public to undergo the new simpler diagnose and test. – BERNAMA

Source

CRM-FIND MoU on innovative Hepatitis C diagnostic test – BERNAMA

KUALA LUMPUR, Aug 6 (Bernama) — Clinical Research Malaysia (CRM), a non-profit company owned by the Ministry of Health (MOH), and Foundation for Innovative New Diagnostics (FIND) today signed a memorandum of understanding (MoU) to collaborate in research and development of an innovative Hepatitis C diagnostic test.

The initiative is in continuation of a partnership with the Drugs for Neglected Diseases Initiative (DNDi) and forms part of a larger FIND project known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), supported by International Drug Purchasing Facility (Unitaid).

Malaysia is the only high-middle-income country included in the project.

The MoU was signed by CRM chief executive officer, Dr Akhmal Yusof and FIND chief access officer, Zachary Katz. It was witnessed by Health Minister, Dr Dzulkefly Ahmad, Health director-general, Datuk Dr Noor Hisham and head of FIND’s HCV & HIV Unit, Dr Francesco Marinucci, among the officials.

Dr Akhmal said, “It is a great honour to be part of this research and development effort with FIND, that will eventually lead to more cost-efficient and earlier detection of Hepatitis C. In line with our effort to be a globally trusted organisation and participate in research that matters to Malaysians, we will continue to strive to deliver together with our partner, FIND.”

CRM in a statement said although the World Health Organisation (WHO) has pre-qualified different types of HCV (Hepatitis C virus) tests, screening vulnerable and hard-to-reach populations remains a challenge due to centralised health services, making it difficult to identify those with the disease who need to be linked to care and treatment.

FIND will demonstrate the feasibility of using rapid diagnostic tests (RDTs) in decentralised primary healthcare facilities and provide technical assistance to the MOH in Malaysia to support the project.

HCV is one of the world’s most common infectious diseases, usually contracted through unsafe healthcare and injection drug use.

Globally, more than 71 million people are chronically infected, with over 80 per cent of them living in low- and middle-income countries – but only one in five people know they have the disease.

In Malaysia, the HCV disease burden is high and predicted to rise steeply over the coming decades, leading to a projected 63,900 HCV-related deaths by 2039.

– BERNAMA