The Malaysian government has committed funding to improve the healthcare systems in order to further support clinical research. Clinical Research Malaysia (CRM) is a non-pro t organisation – wholly owned by the government of Malaysia, which intends to develop infrastructure for the Clinical Research Centre networks, and be able to support global industry sponsored research (ISR) requirements. Recently, CRM appointed a new CEO, Dr Akhmal Yusof, who held individual meetings with various industry sponsors and CROs to promote the services provided by CRM. George Clinical Malaysia (GCM) was one of the CROs invited to participate. In addition to this, Dr Akhmal met with MOH investigators and institution directors to promote clinical research, as well as discuss ways to improve facilities and resources available to conduct clinical research.
To date, Malaysia has more than 80 ISR trial sites which have been approved by the Ministry of Health (MOH) and consists of an amalgamation of public and private hospitals. At the end of 2014, 202 new ISR trials were approved by the institutional review board (IRB). CRM targets 214 new trials for 2015, and their vision for 2020 is to conduct 1000 ongoing trials in Malaysia.
George Clinical Malaysia met with Dr Akhmal and discussed about initiating improvements to the site contracting process – in particular improving ethics approval timelines, which is currently one of the most time consuming hurdles for site start up. In order to alleviate this situation, CRM is in discussion with their legal officers along with the MOH legal advisor officer to update a bipartite clinical trial agreement (CTA) template for MOH sites. In addition, Malaysia recently introduced the goods and services tax (GST) which has affected the CTA and budget. To ensure smooth implementation of GST, CRM developed a CTA addendum for this GST clause. George Clinical Malaysia also suggested to CRM to construct a comprehensive database on patient populations for dedicated therapeutic areas at all MOH sites. This database will facilitate feasibilities and reduce start up timelines, as well as attract the industry.
Dr. Akhmal laid out five key strategies that have been the focus of CRM; grow the number of Principal Investigators and sites, attract new ISRs to Malaysia, enhance cooperation and collaboration with the stakeholders, create awareness of CRM among the medical fraternity, public and patients, and lastly, commit to developing human capital.
CRM has invested heavily in improving the facilities at the various clinical research sites as well as sponsoring Investigator’s Award in conjunction with the State Research Day. These initiatives were undertaken to grow the number of investigators and sites. Apart from this, CRM has improved the efficiency of its feasibility process by creating a dedicated database of PIs. This effort improved the number of feasibilities by 300% compared to previous years, with a 50% growth in new Sponsors. By actively participating in national and international conferences and exhibitions, CRM managed to create awareness among the local and foreign industry players. This resulted in a 200% growth in inquiries from interested parties about ISR opportunities in Malaysia.
As one of Malaysia’s key hurdles being the lack of quality resources in comparison to international standards, CRM has initiated refresher courses for MOH investigators and Study Coordinators. George Clinical Malaysia actively works with Principal Investigators to share information on these trainings to new investigators or unexperienced Study Coordinators. As a result of this, sponsors and CROs will gain a greater sense of assurance that Malaysia possess the necessary skills to conduct various clinical trials, while delivering a service of high quality.
Originally published in http://www.clinicalresearch.my/crmbulletin/ Issue 7