Malaysia made history this month when one of its Medical Oncologist, Dr Voon Pei Jye from Sarawak General Hospital (SGH) became the first Malaysian to be invited to co-author a First-in-Human trial publication. The results of the clinical trial was presented as a late-breaking oral presentation at the AACR-NCI-EORTC International Conference 2023 in Boston. Dr Voon’s significant contribution to the First-in-Human trial led to him being named as co-author in this distinguished platform. The said trial that was recently initiated in SGH in June this year, also places SGH and Dr Voon alongside top-ranking cancer institutes globally, and this include the highly renowned Memorial Sloan Kettering Cancer Center (2nd in global ranking) and the Dana-Faber Cancer Institute (8th in global ranking) both located in the United States.
Dr Voon was also recognized as the Regional First Recruiter for this First-in-Human clinical trial that aims to assess the preliminary safety and anti-tumor activity of an investigational product, which is a first-in-class, KRASG12C inhibitor in patients with advanced solid tumors with KRASG12C mutations. Dr Voon attributed his success to his dedicated team of Study Coordinators, Erfan and Li Fang, as well as the Clinical Research Centre (CRC) team at SGH as they have been instrumental to the delivery of the clinical trial.
The progress Malaysia has made in the space of early phase clinical research is the testament to the success of Clinical Research Malaysia (CRM) Phase 1 Realization Project (P1RP), which was initiated in 2016 as a five-year plan to ensure the country’s readiness for safe and quality conduct of early phase research. The P1RP project was fully funded and executed by CRM, a corporatized site management organization that is fully owned by the Ministry of Health.
Many of the nation’s firsts were accomplished from this project, including the development of the Malaysia Phase 1 Clinical Trial Guidelines, establishment of a Phase 1 accredited facility in SGH and establishment of a Scientific Review Panel. CRM also sponsored the training and development of three National Pharmaceutical Regulatory Agency officers in 2017 and 2018, as well as Dr Voon Pei Jye in 2020. While the P1RP concluded in 2021 with the return of Dr Voon from his fellowship training at the Princess Margaret Cancer Center in Toronto, CRM embarked on P1RP 2.0 to further expand its investment in human capital development, particularly in training and attachment of clinical research study coordinators and clinicians in early phase centres, and attracting more early phase trials into Malaysia.
Clinical trials often address the unmet medical needs of patients, particularly those who have exhausted all treatment options available. It also provides patient with early access to ground-breaking and innovative treatments that otherwise would not be available in the market as it may take years before a particular drug or treatment is registered by health authorities. It is with this principle of Humanity that CRM is guided to ensure patients in Malaysia will not be left behind in the promising drug development pipelines that the rest of the world is taking part in. To date, Malaysia recorded more than 2000 sponsored research since 2012, over 2600 skilled jobs in clinical research was created, and more than RM 1 billion of gross national income generated through clinical research contract values.
