Deputy Director-General of Health (Research and Technical Support), Ministry of Health Malaysia conferred the Darjah yang Mulia, Panglima Jasa Negara award which carries the title ‘Datuk’ in conjunction with the official birthday of the Yang di-Pertuan Agong Tuanku Abdul Halim Mu’adzam Shah.
[Putrajaya, 20 May 2016] Malaysia is fast becoming the preferred destination for industry sponsored clinical trials; from 143 trials in 2010 to 201 trials in 2015, a 41% increase. However, of the 201 clinical trials conducted in 2015, only one Phase 1 study was conducted, with the majority of the rest of the studies being in Phase III. The development of the Phase 1 guideline marks an important step in the Phase 1 Realization Project (P1RP) blueprint.
Phase I clinical trials play a key role in enhancing the capability of Malaysia in the development of medical science and treatment of diseases. Local pharmaceutical and biopharmaceutical industries will gain first-hand experience in ensuring the efficacy and safety of new drugs. The Government of Malaysia is committed to developing Malaysia into an internationally renowned centre of excellence for the development of new drugs and treatment strategies.
Keynote Address: P1RP and the Malaysian Ecosystem by YB Datuk Seri Dr. S. Subramaniam, Minister of Health Malaysia
“There are multiple economic advantages in opening our doors to early phase studies,” said Datuk Seri Dr. S. Subramaniam, the Minister of Health. “Firstly, is the transfer of knowledge and technologies to Malaysians. Many of these small trials test cutting-edge treatments and technologies that can only be applied and experienced through the conduct of early phase clinical studies.”
YBhg. Datuk Dr. Noor Hisham (Director General of Health Malaysia), YBrs. Dr. Akhmal Yusof (CEO of Clinical Research Malaysia, YB Datuk Seri Dr. S. Subramaniam (Minister of Health Malaysia) & YBrs. Dr. Goh Pik Pin (Director of CRC National) ushered by Ms. Krishna Veni (CRM Business Development Executive)
He also said, “We have many things to be proud of about our Malaysian clinical research ecosystem; for instance we have the Clinical Research Ward at Ampang Hospital and the Sarawak General Hospital which have invested heavily in building their respective capacity to conduct early phase studies; we have a large pool of dedicated well-trained investigators, clinicians and support staff; there is an extensive information and referral system; and the Government is staunchly committed to always placing the patients first. In other words, the infrastructure, processes, systems and manpower are well in place. Hence there should be no more debates about whether Phase I should be conducted or not, the time has now come for us to make this into realization via P1RP.”
“The challenges are real, but I am confident the benefits outweigh them. The amount invested by the Government into building the capability and capacity for Phase I studies will in time deliver its intended benefits and with the completion of the clinical research ecosystem, we target to achieve 300 ISR trials by 2019,” said Datuk Seri Dr. S. Subramaniam.
Clinical Research Malaysia (CRM)
CRM is a non-profit company wholly owned by MOH, established to position Malaysia as a preferred global destination for industry-sponsored research (ISR). CRM support growth in ISR, facilitate the needs and requirements of industry players, grow the pool of capable investigators, support staff and trial sites. www.clinicalresearch.my
Clinical Research Centre (CRC)
CRC is one of the six research institutes under the National Institute of Health (NIH) Ministry of Health Malaysia (MOH). CRC functions as the clinical research arm of the MOH. It has 33 branches located at major MOH hospitals as well as in the National Cancer Institute. CRC supports and facilitates research activities, particularly Investigator Initiate Research.
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