PUTRAJAYA, March 22 – Sponsored clinical research in Malaysia recorded an exceptional performance in 2021, surpassing its previous years accomplishments, as highlighted in Clinical Research Malaysia’s (CRM) Annual Report 2021. The report was launched earlier today by the Minister of Health, YB Khairy Jamaluddin at the Ministry of Health complex in Putrajaya, witnessed by CRM Board of Directors and stakeholders.
The annual report detailed 215 new sponsored clinical research in the country, the highest annual number reported since CRM’s inception. In 2021, Malaysia moved a position up, now ranking second within Southeast Asia region after Singapore, in terms of the number of global industry sponsored studies.
These record-high numbers were also reflected in the Gross National Income generated, with highest annual value of RM 226 million investment reported from new sponsored studies, contributing to a cumulative value of RM 834 million generated from sponsored research since 2012.
Sponsored clinical research are usually funded by pharmaceutical companies, to conduct clinical trials that involve a research treatment or therapy. In Malaysia, half of these studies are conducted in public hospitals and primary health care centers, with the rest being conducted in university hospitals and private medical centers.
Ministry of Health (MOH), through CRM, have spearheaded the drive for sponsored clinical research in the country, by ensuring deliverance of speed, quality, and reliability in study conduct. Having been established as a one-stop center for sponsored research in the country in 2012, CRM is also an ISO 9001:2015 Quality Management System and ISO 37001: 2016 Anti-Bribery Management System certified organization, remaining steadfast in being a global trusted research management organization to its partners.
“The Ministry of Health remains committed in supporting the continuous growth of clinical research in Malaysia. We are especially proud of the achievements and accomplishments of our investigators in delivering quality study conduct, some of whom were recognized as top global and regional recruiters in multinational studies”, remarked YB Khairy during the event.
The event also saw the unveiling of the Phase 1 Realisation Project (P1RP) Report, wrapping up the five-year initiative which began in 2016. The P1RP was developed by CRM with the support of the Ministry of Health, mainly to ensure readiness of Malaysia’s clinical research ecosystem for safe and quality conduct of early phase research, especially First-in-Human (FIH) studies.
Many of the nation’s firsts were accomplished from the project, including the setup of Phase 1 guidelines, establishment of a Phase 1 accredited facility in Sarawak General Hospital (SGH), and the conduct of a First-in-Patient study in 2021. In addition, CRM had also sponsored the training and development of three National Pharmaceutical Regulatory Authority (NPRA) officers as well as Dr Voon Pei Jye, a medical oncologist from SGH, in their completion of postgraduate studies and fellowship respectively, centered in early phase research.
With the conclusion of P1RP in 2021, CRM has further supported the enhancement of FIH capabilities and capacities in Malaysia, by delivering on the needed framework, trained regulators, equipped study site and experienced study team in place.