| |
|
| |
 |
| |
| What are the advantages of South East Asia for clinical research? |
| |
Subject access
- ASEAN countries have total population over 500,000 million with excellent health care infrastructure, in particular Thailand, Malaysia and Singapore (100 million inhabitants) at cost well below western world.
- Greater willingness to participate in clinical trials.
Sites and investigators
- Underutilized local investigators educated at top institutions globally, providing services at far better prices than in US, Europe or Japan.
- By now widespread and increasing competence in ICH-GCP guided research and IND studies.
- Excellent PK facilities and no regulatory obstacles to early phase (first in man) studies.
Good support infrastructure
- in terms of certified laboratories, warehouses, transportation, and overall infrastructure.
Patient population
- Highly literate population in Thailand, Malaysia and Singapore.
- Exceptional adherence rates and reachable subjects (near 100% mobile phone penetration).
- Access to great variety of patient populations, including metabolic disorders, cardiovascular diseases, oncology, pulmonology etc. in addition to unique opportunities in infectious diseases (dengue, TB, HIV, hepatitis).
Regulatory environment
- Greatly improving ECs and increasingly efficient regulatory bodies, also supported by government policies.
- Rapid recruitment at smaller number of sites, leading to better study expertise and adherence on site.
- Increasing market size, smaller than China or India in terms of consumers but larger than EU or US.
|
| |
Strengths of Ecron Acunova in SAE: Centre of excellence in Nutrition & HIV
HIV: The majority of Bangkok based staff have been actively affiliated with HIV-NAT for up to 14 years, a clinical trials organization with 90 HIV clinical studies (including US FDA IND studies) and 80 peer reviewed articles to its name. HIV-NAT is a recipient of two major US NIH research grants, is a UNAIDS collaborating center, and a site mentioned in the Lancet as ‘a good example of a three-continent collaboration in clinical trials and patient care’. HIV Studies conducted by Bangkok based staff with globally acknowledged KOLs in the field of HIV involve nearly all of the currently registered antiretrovirals, but also HIV vaccine and cytokines. Study expertise ranges from PK to phase IV and from newborns to adults. The Bangkok team boasts a drop-out rate of only 3% over 7 years in a cohort of 367 HIV+ subjects treated with IL-2 (a US IND study conducted according to CFR 21 regulations) and the team is involved in annual HIV treatment training symposiums for health care workers in the region.
Nutrition: The Bangkok team has conducted nutritional studies in mostly infants and toddlers in Thailand, Malaysia and Vietnam (more than 700 subjects combined), but also boasts the highest recruiting site globally in an HIV nutritional study. Nutritional studies are highly specific in their needs and requirements and the specific expertise gained and good outcomes have brought sponsors back for more. Regulations for nutritional studies are less well defined globally and in particularly in Southeast Asia as well but the EACL team has successfully navigated this environment to date and stays abreast of any new developments. In addition, non-medical nutritional studies are often regarded less by investigators in developed countries, while in Southeast Asia top-notch investigators can be engaged in nutritional trials.
|
| |
Regulatory/approval timelines, best estimates
Thailand: Protocol approval time 2 months at academic sites, 4 months if involving other sites requiring MOH approval. Study drug import approval 2 weeks. Total 4.5 months max, while many studies can be limited to academic sites.
Malaysia: Same as Thailand.
Singapore: 2.5 months max; HA and EC submission in parallel.
Vietnam: Up to 6 months total; consecutive submissions EC (first) and MOH (second). |
|
|
