SGH – preferred clinical trial site

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Khairy witnesses the MoU signing between SGH, CRM, and Novartis Malaysia, while Dr Sim and others looked on.

By Natasha Jee and Alexandra Lorna

KUCHING: The Sarawak General Hospital (SGH) is set to be a preferred clinical trial site in the country.

This follows the signing of a Memorandum of Understanding (MoU) between Clinical Research Malaysia (CRM), Novartis Malaysia and SGH.

SGH was represented by its director Dr Ngian Hie Ung, CRM by its chief executive officer Dr Akhmal Yusof, while Novartis Malaysia was represented by its country president Dr Mohamed Elwakil.

Health Minister Khairy Jamaluddin said the collaboration marks an important milestone in cementing Malaysia as a centre of excellence and a major regional player in medical clinical research.

“With the potential first in human (FiH) trials to be conducted in the country, we hope to comprehend the nature of diseases better, and provide vital information about disease trends and risk factors.

“More importantly, with the inclusion of early phase clinical trials in the country, Malaysian patients will now be able to access innovative therapies and treatments that may have previously been beyond reach,” he said before witnessing the MoU signing ceremony at Clinical Research Centre (CRC) Auditorium in SGH on Monday (Sept 5).

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Khairy said since 2012, Malaysia has conducted over 1,900 sponsored clinical researches, and Malaysia conducted 215 new sponsored clinical research projects for a total contract value of RM226 million where Novartis was the top contributor of new sponsored clinical researches in the last decade.

“With this MOU, we will now be Novartis’ preferred site and this is significant for the industry in three ways.

“From a research perspective, SGH will now become a centre of excellence in Malaysia for clinical trials – one that can cater for different phases of clinical trials, from FiH clinical trials to late phase clinical research,” he explained.

He added that from a patient’s perspective, clinical trials offer hope as patients who are part of a clinical trial may be the first to try a novel therapy.

“The close monitoring and evaluation done by a group of healthcare experts to ensure treatment safety and efficacy can be a booster for a patient’s morale,” he said.

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Khairy also said MOUs such as these create a platform to enhance capacity building among local talents, clinical trial quality and provide an opportunity for local drug discovery.

“With the strengthening of CRM, Malaysia aims to increase and promote more local and international research collaborations in line with healthcare development.

“Through the work led by CRM’s Phase 1 Realisation Project that aimed to establish and enhance the nations’ early phase capabilities and capacities, many of the nation’s firsts were accomplished from this project, including the development of Phase 1 Guidelines, establishment of the SGH Phase 1 site, training, and development of three National Pharmaceutical Regulatory Agency (NPRA) officers as well as fellowship attachment of our fellow oncologist,” he said.

Following this, he said SGH successfully conducted its first in-patient hematology study last year.

“The site investigator, Dr Chew Lee Ping is recognised as the first global recruiter in the study, ahead of other global sites. We have also more to look forward to from the team at SGH, especially with the return of Dr Voon Pei Jye, one of our top investigators in the country, following his fellowship in early phase research at Princess Margaret Cancer Center, Toronto,” he said.

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Khairy said these ongoing efforts to strengthen the clinical research and trials footprint in Malaysia were an integral part of Novartis’ mission to improve and extend the lives of patients.

“Novartis’ and its predecessor companies’ collective centuries of expertise in healthcare research, coupled with Switzerland’s healthcare system consistently ranking first in the World Index of Healthcare Innovation, can hopefully bring about a more data-driven, digitally-innovative healthcare system here in Malaysia,” he said.

Also present was Deputy Premier Datuk Seri Prof Dr Sim Kui Hian.

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