PETALING JAYA, Oct 16 — Universiti Malaya Medical Centre (UMMC) has marked a major milestone in clinical research with the unveiling of its Phase I Unit at the Clinical Investigation Centre (CIC), the first facility of its kind within a Malaysian teaching hospital.
Phase I clinical trials are the earliest stage of testing new investigational drugs and medical devices in humans, focusing primarily on safety, tolerability and dosage before moving on to later phases of research.
The new unit is purpose-built to conduct First-in-Human and Phase I studies under hospital-standard conditions, and is progressing towards accreditation by the National Pharmaceutical Regulatory Agency (NPRA).
“The establishment of this unit is a significant milestone for UMMC as a teaching hospital and research centre. For patients, it means the possibility of accessing innovative treatments much earlier in a safe and closely monitored environment.
“At the same time, it strengthens our role in training doctors, researchers, and students, giving them invaluable hands-on experience in the complexities of early-phase clinical research,” said Prof Dr Nazirah Hasnan, hospital director and consultant rehabilitation physician at UMMC.
The Phase I Unit has been designed as a self-contained facility within UMMC, essentially operating as a “mini hospital” for research participants. It houses 10 clinical beds, including two observation rooms for intensive monitoring, and offers 24-hour medical oversight with seamless access to UMMC’s emergency and specialist services.
The unit, which is undergoing renovations, will be located at Menara Timur, Level 3, chosen for its accessibility and suitability as a specialised research facility.
The unit also features an in-house pharmacy with controlled storage and dispensing that complies with NPRA and ICH-GCP standards, as well as a Class II Biological Safety Cabinet for sterile handling of cytotoxic and high-risk investigational products.
Together with UMMC’s multidisciplinary expertise, this creates a unique bench-to-bedside ecosystem that advances scientific discovery while directly benefiting patient care.
Beyond First-in-Human and Phase I studies, the unit has also been designed to support selected Phase II trials, chemotherapy infusions, and the administration of cell and gene therapies, although manufacturing will not be conducted on-site.
“Every detail has been planned to meet the requirements of early-phase trials. From drug handling to patient monitoring, our processes are built on recognised clinical standards. This allows us to take on complex First-in-Human studies within a teaching hospital environment,” said Prof Dr Lim Soo Kun, head of the Clinical Investigation Centre, UMMC.
Oncology will serve as the flagship specialty for the Phase I Unit, reflecting the urgent need for new therapies in cancer care. Beyond oncology, the facility can also support rheumatology, neurology, haematology, respiratory medicine, nephrology and cardiology.
Unlike many centres that focus primarily on healthy volunteers, the CIC Phase I Unit will emphasise patient-based First-in-Human and Phase I studies, ensuring that Malaysians with serious or rare conditions can benefit from access to novel therapies earlier.
The establishment of the unit has been guided by NPRA’s Phase I requirements, Good Clinical Practice (GCP), and international standards. Staff are undergoing structured training and certification, while standard operating procedures (SOPs) have been developed to address the unique risks of early-phase trials.
Recent activities include knowledge-sharing sessions with international experts, early-phase workshops during the Clinical Research Malaysia (CRM) pre-conference, and continuous upskilling of CIC investigators and coordinators.
“Our readiness plan covers people, processes and place. The unit is directly linked to emergency pathways, and SOPs are written with Phase I risk management in mind. Our staff are being trained to handle complex early-phase work. This ensures that First-in-Human studies are both safe and feasible in a teaching hospital environment,” said Dr Mohmmad Salleh Yahya, deputy director of clinical (medical), UMMC.
The soft launch of the Phase I Unit marks the beginning of its journey. Once NPRA accreditation is secured, the facility will become fully operational and ready to host early-phase clinical trials in 2026.
By placing this capability within a teaching hospital, UMMC will strengthen its dual role in advancing research and training future clinicians.
Most importantly, the Phase I Unit gives patients the opportunity to access new therapies earlier and in a safe, closely monitored environment.
