Updated on 17 September 2013
Increasing involvement of regulators in GCP clinical trials, both global and local, in Vietnam, is attracting more trials to the country.
The clinical research environment in Vietnam has grown in the right direction with some remarkable achievement, in the last decade. However, in order to be a better destination for clinical trials, all the key players including Vietnam Ministry of Health (MoH), Ethics Committee (EC), investigational sites that participate in clinical trials and investigators, and sponsors for clinical research organizations (CROs) and site management organizations (SMOs) that provide site management service to hospitals, have to cooperate more actively.
Vietnam needs to learn from the successful endeavors of developed countries, especially in improving relevant laws and regulations, and to build up a synchronized system to ensure the smooth process for clinical trials, effective intellectual property protection for pharma/biotech companies, the legal assurance for institution and investigators, and beyond all, the safety and human rights of study subjects while still participating in the research and development of modern medicine/technology through early phase clinical trials and through own local research and development center in the future.
The first multinational clinical trial involving Vietnam was registered in ClinicalTrials.gov, a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world, in 2002.
Although, Vietnam has come a long way since it humble beginnings as clinical trial destination, it is still many steps away from becoming a sought after center for clinical trials and match up to its neighboring countries like Thailand, Singapore, Philippines or Malaysia. In the past few years, many initiatives were taken towards clinical research in drug and healthcare development by Vietnam Ministry of Health (MoH). Also, the MoH endorsed several activities including a workshop on clinical research environment in Vietnam for CROs and SMOs in 2011, release of a circular on clinical trial guidelines in 2012, providing guidance on CRO and SMO activities in 2012, and two workshops, so far, this year to finalize detailed circular on this matter.