Intense competition for patients and clinical trial sites is making it harder to enrol studies in Asia-Pacific on time. In response, contract research organisations (CRO) are looking beyond traditional markets.
“I expect Vietnam and Cambodia to emerge as clinical trial regions. Large CROs are exploring these countries due to competition for patients in other areas of Asia-Pacific”, James Tsui, contracts and outsourcing manager for Roche in Asia-Pacific, said atPatient Recruitment Outsourcing (PRO) 2011.
Competition in oncology, cardiovascular disease, central nervous system, and diabetes is intense. The number of qualified trial sites is a limiting factor. Options are cut further, Tsui said, as some study centres prioritise recruitment of trials sponsored by CROs and biopharm to which they are affiliated.
Instead of focusing resources on out-competing rival trials some CROs are looking to less crowded countries such as Cambodia and Vietnam, Tsui said. A 2008 PricewaterhouseCoopers’ (PwC) report said the countries are the highest risk outsourcing locations in Asia-Pacific but they do offer benefits.
Combined the countries have a population of more than 100m people but just 26 open studies listed on ClinicalTrials.gov. Also, the PwC report said they are the lowest cost countries in Asia-Pacific, mainly because expenditure on compensation and wages undercuts other nations in the region.
Quintiles is already active in Phase II and III trials in Vietnam and has 20 staff at two offices, Anand Tharmaratnam, senior vice president and head of Asia markets, told Outsourcing-Pharma. The CRO is growing its presence in Vietnam but is yet to conduct feasibility studies on entering Cambodia.
Know your market
For CROs, an alternative to expanding geographically is being more effective in the countries in which they already work. Local understanding, as has been said before, is critical to making these gains.
Recruitment strategies that work in Western markets may be ineffective in Asia-Pacific, Tsui said, as people are sceptical of clinical trials but trust healthcare professionals. However, the workload of principal investigators means they may struggle to find time for clinical trial recruitment.
In many countries enrolment is shared across a network of clinics and sub-PIs that send patients to clinical trials. Failing to understand the network and the patient populations it can access will limit recruitment rates, Tsui said.
CROs must also understand the situation in China. Clinical trials face long regulatory approval times and Tsui said the situation is unlikely to improve in the next two years. The Chinese government is motivated to improve the clinical trial process, Tsui said, but bureaucracy means the process is slow.
A PRO 2011 attendee said submitting a draft protocol for consideration by Chinese regulators can cut the time between first thinking about a trial and enrolling patients. In the time between submission and regulatory review the company can finalise the protocol, saving a little time.