KUCHING: The Clinical Research Centre, Sarawak General Hospital (CRC SGH) began its First-in-Human (FIH) Clinical Trial on Friday (Apr 6).
The FIH clinical trial was led by Consultant Medical Oncologist and Head of Radiotherapy & Oncology Department of SGH Dr Voon Pei Jye.
CRC SGH is the first site in Malaysia to obtain approval from the Ministry of Health (MoH) to undertake FIH clinical trials.
Among the thirty-seven CRCs of the MoH nationwide, CRC SGH stands out as the only purpose-built facility within MoH hospitals with the capacity to conduct Phase I to IV of clinical trials onsite.
The facility features a fully monitored 10-bed ward, ISO-accredited laboratories, dedicated pharmacies, and a human physiology laboratory.
It is also capable of conducting clinical trials for pharmaceuticals, nutraceuticals, food science research and medical devices.
“There are four phases of the clinical trial, with the first phase being crucial for assessing safety of the new treatment in humans, as it is the first time a new drug is given to a human.
“The majority of FIH and Phase one of clinical trials are in the treatment of cancer such as oncology.
“It requires special preparation, trained medical personnel, and approvals from relevant agencies including the Medical Research and Ethics Committee and National Pharmaceutical Regulatory Agency,” it said in a statement.
CRC SGH is a partner site for global contract research organisations (CROs), including IQVIA, Parexel and Novotech, and local CROs including Borneo Kinetics.
They work closely with Clinical Research Malaysia (CRM), the Sarawak Research and Development Council (SRDC) to enhance the clinical research ecosystem and accelerate the process of translational research.
Deputy Premier Datuk Seri Dr Sim Kui Hian, Director of SGH Dr. Ngian Hie Ung, Medical Oncologist and Head of Radiotherapy, Oncology and Palliative Care Department of SGH Dr. Voon Pei Jye, and Head of Clinical Research Centre Unit of SGH Dr. Alan Fong deliberated on the issues at the online meeting.
