Malaysia starts global “Solidarity Trial” – a research effort to test possible treatments for COVID-19

PUTRAJAYA, 6th April 2020 – The “Solidarity Trial”, launched by the World Health Organization (WHO), will see Malaysia’s involvement in an international effort to test several drugs in treating COVID-19.

The WHO globally coordinated trial is an unprecedented effort to collect reliable data and compare the safety and effectiveness of four treatment protocols using different combinations of Remdesivir, Lopinavir/Ritonavir, Interferon beta, Chloroquine and Hydroxychloroquine.

The Director General of Health, Ministry of Health (MOH) Malaysia Datuk Dr Noor Hisham Abdullah said, MOH has fast-tracked the process to implement the drug trials to treat patients with COVID-19, which will begin soon. The nine MOH hospitals included are Tuanku Fauziah Hospital, Sultanah Bahiyah Hospital, Pulau Pinang Hospital, Sungai Buloh Hospital, Kuala Lumpur Hospital, Melaka Hospital, Tengku Ampuan Afzan Hospital, Sarawak General Hospital and Queen Elizabeth Hospital.

“The global pandemic is affecting more than 180 countries, and one of these drugs may be our best hope for treating people infected with COVID-19,” said Dr Ying-Ru Lo, the Head of Mission and WHO Representative to Malaysia, Brunei Darussalam and Singapore. “This is our chance, as a global community, to turn the tide against the pandemic. Malaysia will be a valued partner in this trial to evaluate potential treatments that are more effective, and to save lives in the global battle to fight this virus.”

The research will be headed by Dr Chow Ting Soo, Infectious Disease (ID) Consultant at Pulau Pinang Hospital with a team comprising of 16 ID physicians and pharmacists as Co-Investigators at the respective MOH hospitals. Director General of Health, Datuk Dr Noor Hisham Abdullah gave his assurance that the trial will adhere to all safety standards set by the National Pharmaceutical Regulatory Agency.

“Malaysia’s participation in this worldwide trial could help find life-saving medicines for COVID-19 through evaluating their safety and effectiveness,” said Datuk Dr Noor Hisham Abdullah. He added that MOH Institute for Clinical Research (ICR) and Clinical Research Malaysia (CRM) would help facilitate the implementation of the WHO-initiated trial in Malaysia.

 

Media contact :
WHO: Dr Cory Couillard, Consultant WHO Country Office in Malaysia: couillardc@who.int;  +6017 6487520
MOH Malaysia: Dr Goh Pik Pin; Ministry Of Health Malaysia; gohpp@moh.gov.my;  +6013 3336822

 

Source: WHO Joint News Release

I Am Aware Photography Series Launch and Exhibition at Ministry of Health, Putrajaya

PUTRAJAYA, 19 December 2019 – The Ministry of Health aims to improve and provide better health care in the country by supporting the clinical research industry as well as in promoting participation in clinical trials.

Clinical trials which are largely funded by global pharmaceutical, medical device and biotechnology companies brings various innovative treatment options to clinical trial participants. Patients who participate in clinical trials receive either a promising new treatment or the best available conventional treatment. Especially in the area of cancer treatment, clinical trials have been proven to offer some of the most effective cancer treatments currently available today.

These clinical trials are often been misconstrued as experimental testing on patients despite the significant impact made on improving medical treatments. The misconception continues with the public’s limited understanding due to the lack of exposure on clinical trials.

The Health Ministry seeks to correct these misconceptions as well as improve the awareness of clinical trials among Malaysians. Through its corporatized entity, Clinical Research Malaysia (CRM), the I AM AWARE Photography Series collections were developed to raise the profile of clinical trials among patients and the general public in the country.

The Photography Series launched by the Secretary General of the Ministry of Health, YBhg Dato’ Seri Dr. Chen Chaw Min, on behalf of the Health Minister, features a photo collection of real-life patients that have participated in a clinical trial. It portrays the different stages of a clinical trial patient’s life, sharing their experience before and after participation. “Malaysia is an ideal clinical trial site because it has an adequate and efficient healthcare system with a strong pool of highly qualified medical professionals, consistent start-up timeline, competitive trial cost and strong commitment from the MOH that maintains the quality and integrity of clinical trials in our country. I hope that with this initiative, more Malaysians will understand the innovative treatments brought about by clinical trials and can make better informed decisions”, said YBhg Dato’ Seri Dr. Chen during the launching of the ceremony.

In order to reach wider audiences at the national level, mobile exhibition roadshows as well as instilling awareness through this photography series collection will be touring the country at major public and private hospitals from next year onwards to engage with patients. The photography series, comprising of stand-alone panels and booklets, showcases the core part of clinical trial which is the unsung heroes that have contributed to research that may improve medical treatments and advance medical science.

 

 

 

 

Visit our social media for more photos : FB Clinical Research Malaysia

 

First Facility in Malaysia Accredited under the Phase 1 Unit Accreditation Program by National Pharmaceutical Regulatory Agency

CRC SGH Team

 

Heartiest congratulations to Clinical Research Centre (CRC) Sarawak General Hospital (SGH) for being the 1st facility in the country to be accredited under the Phase 1 Unit Accreditation Program by National Pharmaceutical Regulatory Agency (NPRA).

CRC SGH Phase 1 Unit is an integrated facility with its own ward, pharmacy, procedure room, sample processing facility, clinical laboratory and a human physiological system testing assessment area (human cardiac/respiratory and neurology assessment). The unit is listed under the NPRA Phase 1 Accreditation programme. CRC SGH has a multidisciplinary team of research professionals who are trained and experienced in all aspects of clinical trial conduct in various therapeutic areas. The facilities at the site include: 

  • a dedicated 10 HDU bedded ward with 2 ICU equipped beds; 
  • temperature monitored drug storage areas with restricted access; 
  • a sample-handling area with refrigerated centrifuge; 
  • refrigerators and freezers (all temperature monitored) for drug and sample storage; 
  • synchronized digital clock; 
  • a physiology laboratory with instruments for cardiac, lung respiratory and neurological system assessment; 
  • a core laboratory. The laboratory at CRC SGH is MS ISO/IEC 17025: 2017 accreditated to perform drug plasma concentration analysis from June 2019 onwards. The laboratory is also MS ISO 15189: 2014 accreditated for medical testing which includes hematology, coagulation, biochemistry and immunoassay tests from November 2019 onwards; 
  • a dedicated procedure room; 
  • a subject recreation area; and 
  • Wi-fi enabled remote access monitoring capability. 

CRC SGH Phase 1 Unit is able to conduct: 

  • Early Phase Research in Human 
  • Proof of Concept Studies 
  • Single Ascending Dose & Multiple Ascending Dose 
  • Food/ Race/ Gender Effect Study 
  • ADME 
  • Drug-Drug Interaction Study 
  • Food/ Nutraceuticals Study 

In addition, CRC SGH is open to discuss other clinical studies that could potentially be conducted at the site.

 

 

 

 

 

Industry Dialogue 2019/2

CRM Industry Dialogue provides an avenue for Pharmaceutical companies (sponsors) and CROs to directly convey any issues, suggestions or opinions that they may have to CRM. Besides strengthening cooperation and networking between all parties, CRM also takes the opportunity to update the clinical research industry on local laws, guidelines and regulations. By bringing together these industry players, CRM uses this platform to connect with them and provide updates on its current and future activities.

Guest Speakers

We wish to express our sincere gratitude to our special guests, Dato’ Dr Goh Pik Pin (Director, Institute for Clinical Research) and Mr Ewe Kheng Huat (Executive Director of the Pharmaceutical Association of Malaysia (PhAMA))

Dato’ Dr Goh Pik Pin (Director, Institute for Clinical Research)

Mr Ewe Kheng Huat (Executive Director of the Pharmaceutical Association of Malaysia (PhAMA))

We also would like to thank our guest speakers Mr Normanshally Mohammad (Associate Director of Clinical Operations, Merck Sharp and Dohme), Mdm Aiza Adlina Abdullah (Senior Principal Assistant Director, NPRA), Dr Asyraf Syahmi Mohd Noor (MREC Secretariat), Mdm Aidahwaty Ariffin @ M. Olaybal (Head of Technical Evaluation Division, MDA) for sharing important updates with us today.

Mr Normanshally Mohammad (Associate Director of Clinical Operations, Merck Sharp and Dohme)

 

Mdm Aiza Adlina Abdullah (Senior Principal Assistant Director, NPRA)

 

Dr Asyraf Syahmi Mohd Noor (MREC Secretariat)

 

Mdm Aidahwaty Ariffin @ M. Olaybal (Head of Technical Evaluation Division, MDA)

Dialogue Session

We invited all of the special guests and speakers including our Senior Leadership Team (Dr Akhmal Yusof, Ms Joanne Yeoh, Ms Audrey Ooi, and Mr Yau Yit Huan) to have a dialogue session with the industry players. CRM has actively engaged and received feedback from the industry players in the dialogue session to move forward. We are also taking all the constructive feedback into consideration to improve our services and as an aspiration to deliver study with speed, reliability and quality.

Our humble gratitude to all that has make this event successful.

 

VOCAL Study, a Malaysian Perspective – InterVenn

By Ling Shen, Ley Hian, Kiat Yee and Clinical Science Team, InterVenn

Happy Malaysia Day (16th September 2019) to all Malaysians! On behalf of InterVenn Biosciences (InterVenn), I wish all Malaysians unity, prosperity, and importantly, happiness and good health! On this auspicious day, I would like to take some time to reflect on InterVenn’s efforts and contributions to women’s healthcare in Malaysia, and to reaffirm our commitment to reducing the burden of ovarian cancer, and improving the health and wellbeing of all Malaysian women.

Ovarian cancer is the fourth most common cancer among women in Malaysia. Unfortunately, due to the lack of effective tools for accurate early detection and confirmatory diagnosis, most women are diagnosed at an advanced stage, when the disease is less curable. In an effort to address this escalating problem, InterVenn (HQ in Redwood City, California) has established a strategic partnership with Clinical Research Malaysia (CRM) to conduct the VOCAL (Venn Ovarian Cancer Liquid Biopsy) clinical study in Malaysia, strengthening the capacity of our clinical studies as well as applicability of our study results in Southeast Asia, especially Malaysia. Read more

Congratulations to CRM Sponsored Research Award winners!

The CRM Sponsored Research Award is given out each year to outstanding Principal Investigators, clinical trials sites and the industry for their contribution in sponsored research to the nation. It is given to spur and encourage more of such efforts in the future. CRM would like to honour and acknowledge their dedication in participating in sponsored research and hope that they will keep up the good work. Congratulations to all CRM Sponsored Research Award recipients:

INVESTIGATOR & TOP RECRUITER OF THE YEAR

Dr Voon Pei Jye received the Investigator of the Year & Top Recruiter of the Year Award. For Investigator of the Year Award, he conducted the most studies that were initiated in 2018 and has the highest number of oncology trials in that year. He was also PI for 7 studies that was approved in 2018, one of which is a Phase 1, dose escalation study. He also co-authored in 3 publications in 2018 and 8 of his research findings were presented in ESMO Munich, ESMO Asia, World Conference on Lung Cancer, EndoBarcelona and Malaysia-Singapore Congress of Medicine.

For the Recruiter of the Year Award, Dr Voon has achieved first-patient-in within 100 days from site activation in 5 of his studies initiated in 2018. Four out of these 5 studies to date, have successfully reached its recruitment target.

 

CLINICAL TRIAL SITE OF THE YEAR

HOSPITAL PULAU PINANG

Hospital Pulau Pinang received the Clinical Trial Site of the Year Award for having conducted the highest number of sponsored research among all MOH sites. 27 sponsored research trials were conducted at this site in 2018, spanning 13 different therapeutic areas including areas of hematology, infectious disease, nephrology, gastroenterology, oncology and bioequivalence studies.

 

SPONSOR OF THE YEAR

Merck Sharp & Dohme (Malaysia) received the Sponsor of the Year Award for bringing in the highest number of studies that got initiated in 2018 and contributing to the highest value of sponsored research brought to the country.

 

CRO OF THE YEAR

IQVIA™ received the CRO of the Year Award with the highest number of studies and sites initiated in 2018 (9 studies and 22 sites), and having achieved over 71% of the total recruitment from the 22 sites activated.

Creating Awareness of Clinical Trials through Photography


KUALA LUMPUR
, 29 August 2019 – Clinical Trials Day 2019 was celebrated for its third consecutive year at the newly opened Women and Children’s Hospital Kuala Lumpur. This event, organized by Clinical Research Malaysia (CRM) in collaboration with Clinical Research Centre (CRC) of Kuala Lumpur Hospital, aims to elevate the awareness level of clinical trials among patients and the general public in the country.

During the event, an I AM AWARE Photography Series, featuring a photo collection of patients that had participated in a clinical trial, was launched by the Deputy Director-General of Health (Research & Technical Support), YBhg Datuk Dr. Christopher Lee Kwok Choong. The photography series portrays the different stages of a clinical trial patient’s life. The I AM AWARE campaign is one of the community outreach initiatives by CRM together with Universiti Kebangsaan Malaysia, CanWell Group as a strategic partner.

Clinical trials have been perceived as experimental testing and patients most often feel as though they are being used as guinea pigs. Despite the significant impact clinical trials has made on improving medical treatments, this misconception continues as the public’s understanding is limited due to lack of understanding of clinical trials.

In order to reach wider audiences at the national level, mobile exhibition roadshows will be touring the country at major public hospitals throughout the year to engage with patients. The photography series, comprising of stand-alone panels and booklets, showcases the core part of clinical trial which is the unsung heroes that have contributed to research that may improve medical treatments and move science forward.

Creating an Impactful Clinical Trials Day at Women and Children’s Hospital, KL

KUALA LUMPUR, 29 August 2019 – Clinical Trials Day 2019 was celebrated for its third consecutive year at the newly opened Women and Children’s Hospital Kuala Lumpur.

This event, organized by Clinical Research Malaysia (CRM) in collaboration with Clinical Research Centre (CRC) of Kuala Lumpur Hospital, aims to elevate the awareness level of clinical trials in the country, as well as to encourage participation of medical professionals in clinical research.

Clinical Trials Day is part of CRM’s ongoing efforts in enhancing the current clinical research ecosystem in the country by ensuring a robust pool of patients and volunteers for trials, while at the same time continuously investing in the infrastructure of qualified personnel, addressing the industry needs and promoting Malaysia as a hub for clinical research.

During this one-day event, Sponsored Research Award was given to individuals and organizations that have immensely contributed to clinical research in Malaysia. Dr. Voon Pei Jye, a Medical Oncologist from Sarawak General Hospital received the Investigator of the Year award as well as the Top Recruiter Award for his outstanding achievement in oncology trials last year.

The event was officiated by the Deputy Director-General of Health (Research & Technical Support), YBhg Datuk Dr. Christopher Lee Kwok Choong. Datuk Dr. Christopher touched on the importance of attracting sponsored research to the country as it provides access to ground-breaking as well as costly treatments that may not be available to patients outside of a clinical trial setting. He also commended the efforts and achievements of the doctors at Hospital Kuala Lumpur who have gone above and beyond their usual clinical practice to deliver clinical trials of good quality.

Congratulations! Hospital Seberang Jaya for being Top Recruiter in Malaysia

Congratulations! Hospital Seberang Jaya for the achievement of being the top recruiter in Malaysia for a neurology study recently. Kudos to our study coordinator team over in Hospital Seberang Jaya for contributing their effort in making it a success.

Congratulations! #TEAMCRM – PhAMA Annual Games 2019

Congratulations #TEAMCRM on the remarkable achievements in PhAMA Games 2019!