Session 1: 16:10 – 16:25
Setting up clinical trial in resource-limited contexts: challenges andcurrent status (Thailand)
Abstract

Kulkanya Chokephaibulkit, MD. PhD.

(Director, Siriraj Institute of Clinical Research
SiCRES, Mahidol University)

Short CV
Professor Kulkanya Chokephaibulkit graduated and trained in Pediatrics at theFaculty of Medicine Siriraj Hospital.
She then specialized in pediatrics Infectious diseases and epidemiology from the CedarsSinai Medical Center, the University of Tennessee and at Emory University, respectively.
She is currently the Director of Siriraj Institute of Clinical Research (SICRES), Facultyof Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. She is also
Executive Board of national Vaccine Institute of Thailand, Member of Member of Expert
Panel of the Adverse Event Following Immunization (AEFI), Ministry of Public Health,Thailand, and Member of the Subcommittee of Board of National Immunization,
Ministry of Public Health, Thailand.
She is also Clinical Research Site Principal Investigator of International Maternal
Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT)supported by NIH.
She has served as Head of Pediatric Infectious Diseases Unit. Department of Pediatrics,Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Clinical research in resource-limited settings (RLS) is challenging for many reasons.
The regulatory requirement for investigational products importation can be complicatedand lengthy. The ethical review process in RLS can be relatively slower in than the moredeveloped countries. The infrastructures required to support clinical trials—e.g.,
preparation of trial products, protocols and case report forms, data management system,
statistical support, monitoring, and reporting— are not readily available.
Facilities for laboratory testing are insufficient and rarely accredited to meet theregulatory requirement. The quality management system may not be strong. Finally, thehigh routine workload with patient-care services competing priority may distract theinterest of expert clinicians from conducting clinical research.
Research infrastructure and capacity in RLS should be established and sustained. A strong
political support, effective collaboration, adequate expertise and resources, and clear
guidance are needed to overcome these barriers. This requires investments in training andcareer structures to develop a diverse pool of country’s highly skilled researchworkforce.
Clinical research in Thailand has been highly supported recently, but many hurdles
remain. The opportunity is the large diversified patient population available that canpotentially be the subjects. Other strengths include cost-effectiveness in conducting trials,
well-recognized medical schools, a high incidence of tropical diseases, and access tostate-of-the-art medical equipment and facilities. The challenges remain on theinsufficient skillful staff and routine working system to support the research work.
SICRES is the Faculty’s clinical research center and beyond. The experience of setting-up
SICRES, we found collaboration and engagement of public and private partners are
essential parts of how we work. We collaborate with governments, Ministry of Public
Health, Ministry of Higher Education, Science, Research and Innovation and local
partners to build capacity, strengthen research services. We optimize clinical research bylearning from each other’s .