KUALA LUMPUR, Sept 5 – Sarawak General Hospital (SGH) is expected to conduct first-in-human (FIH) studies in 2023, after signing a memorandum of understanding with Clinical Research Malaysia and Novartis.
FIH study, or Phase One clinical trials, is a type of clinical trial that tests new drugs, procedures, or treatments in humans for the first time after laboratory and animal studies.
Health Minister Khairy Jamaluddin said the tripartite agreement will see SGH as the preferred clinical research centre by Swiss multinational pharmaceutical corporation Novartis that has funded the most clinical trials in Malaysia.
He also expects industry-sponsored clinical research this year to exceed last year’s numbers.
“I’m proud because we will have first-in-human clinical trials in SGH next year,” Khairy told a press conference at the Clinical Research Centre at Sarawak General Hospital (CRC SGH) in Kuching, Sarawak, here.
Khairy cited CRC SGH deputy head Dr Chew Lee Ping and SGH medical oncologist Dr Voon Pei Jye as among “world class” principal investigators at the Ministry of Health (MOH) facility.
Dr Voon, he noted, was the first global recruiter for the first inpatient oncology study done last year.
Dr Voon told a webinar last November that the government should improve national policies on clinical research to increase early trials in line with developed nations, particularly in oncology.
He noted that limited Phase One oncology clinical trials in Malaysia were published from 2011 until 2020, with the majority of published Malaysian trials consisting of Phase Two and Three. These publications mainly involved clinical trials of breast and lung cancers in Malaysia, Dr Voon said, “revealing the gaps in the early phase of oncology clinical trials”.
Khairy said clinical research is a “big agenda” on the Health White Paper that he intends to table in Parliament by year end.
“How does it link with the big vision from sick care to health care and wellness? Of course, by having clinical research done here in Malaysia, we can attract the right sort of talent, the right sort of researchers, we can attract the right companies to invest in Malaysia.”
Khairy also pointed out that Malaysia has among the fastest clinical research approval processes in the world, including by the ethics committee and approval by regulators to conduct clinical trials.
He said Russia and Ukraine used to be clinical trial hubs in Europe.
“Now, those countries are at war, so this is an opportunity for us,” Khairy said, adding that Clinical Research Malaysia, a research institute under MOH, will be hosting an international conference in October.
“We will be inviting all the international clinical research specialists as well as pharmaceutical companies to come to Malaysia and to see what we have to offer for clinical research.”