The first First-in-Human (FIH) Clinical Trial commenced at the Clinical Research Centre, Sarawak General Hospital (CRC SGH) on 6 April 2023.
According to CRC SGH media release, the Site Initiation Visit (SIV) of this FIH Study – RMC-6291-001 – was successfully conducted.
This FIH clinical trial is led by Dr Voon Pei Jye, Consultant Medical Oncologist and Head of Radiotherapy & Oncology Department Sarawak General Hospital.
Clinical trials are a specific process to develop new treatments. There are four (4) phases of clinical trials. The most important of these is the Phase 1 clinical trial, where a multidisciplinary team assesses the safety of a new treatment in human beings.
A FIH clinical trial, or FIH study, is the most critical part of the Phase 1 clinical trial because it is the first time a new drug is first administered to a human being. To perform this, all the necessary medical personnel and facility must be specially prepared and trained.
In addition, approvals from the Medical Research and Ethics Committee, the National Pharmaceutical Regulatory Agency and other agencies must be obtained.
CRC SGH is the first site in Malaysia to obtain Malaysia Ministry of Health (MoH) approval to undertake FIH clinical trials, having done so in Nov 2019.
CRC SGH was established in 2003 by YB Dato Sri Prof Dr Sim Kui Hian, and led by Dr Alan Fong, since 2011.
CRC SGH is one of 37 CRCs of the MoH, and is the only purpose-built facility in an MoH hospital, able to undertake Phase I to IV clinical trials onsite.
It has a dedicated 10-bedded fully monitored ward, ISO-accredited laboratories, dedicated pharmacies, and a human physiology laboratory.
It can conduct clinical trials for pharmaceuticals, nutraceuticals, food science research, and also medical devices.
CRC SGH is a partner site for global CROs, including IQVIA, Parexel and Novotech, and local CROs including Borneo Kinetics. It works 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. Ultimately, bringing safer and more effective treatments to our patients.
As part of the Institute for Clinical Research (ICR), one of the six (6) National Institutes of Health (NIH, MoH), CRC SGH strives to lead the clinical research agenda – undertaking research that matters to patients, and ultimately to the population.
The majority of FIH and Phase 1 clinical trials are in the treatment of cancer i.e. oncology. Dr Voon Pei Jye, who leads this FIH clinical trial, is an eminent medical oncologist from Sarawak who underwent specialised training both at the National University Cancer Institute, Singapore, and subsequently at the world-renowned Princess Margaret Cancer Center, Toronto, Canada, supported by CRM.
CRM was established by the MoH in 2012. It exists to advance global health solutions for a brighter, more hopeful future for the people by providing speedy and reliable end-to-end clinical research support for quality studies. CRM has 21 staff based at CRC SGH and provides invaluable support to industry sponsored clinical trials.
Also present at the online meeting was the Deputy Premier of Sarawak, Minister of Public Health, Housing and Local Government of Sarawak, Dato Sri Professor Dr. Sim Kui Hian who is now in Australia, Director of Sarawak General Hospital, Dr. Ngian Hie Ung, Medical Oncologist and Head of Radiotherapy, Oncology and Palliative Care Department of Sarawak General Hospital Dr. Voon Pei Jye and Head of Clinical Research Center Unit of Sarawak General Hospital Dr. Alan Fong.
