Seven Steps To Considering Clinical Trials in Asia



Pharma IQ
09/20/2011

Large patient pools and lower costs are just two of the enticing advantages of conducting clinical trials in Asia. Yet for many in the industry, the inner workings of the Asian market – and indeed the varied markets included under the huge banner – remain a relative mystery.

Here are seven steps to consider before deciding to embark upon clinical trials in Asia.

1. Cost

Reduced costs are one clear advantage of conducting research in the region. As a report from the Association of Clinical Research Organizations (ACRO) noted, the cost per patient of India and China can be as little as one third of that in the United States.

But, this is not the only factor to consider. Logistical costs must be considered and in some cases once these are taken into account the costs are comparable.

Costs also vary from country to country, with South Korea, for example, being noted as being one of the most expensive.

2. Practical considerations and infrastructure

Emerging markets in Asia are unlikely to have the level of infrastructure in place as more established western nations, although the picture certainly varies across the continent.

Nations like South Korea and Taiwan have invested significantly in their clinical research capabilities in recent years, with the end result being greater scientific capabilities and more advanced facilities, although these are likely to come at a cost.

Wide variations are also likely to exist between institutions in the same country, although the situation is improving. ACRO noted major hospitals in China are making efforts to attract western-trained expatriates back to work in the country.

The level of support the location needs will be greatly determined by the expertise in the individual facilities chosen.

3. Cultural differences

Even once the practical considerations of running a clinical trial in an emerging market have been addressed, cultural challenges are likely to remain.

Partnerships with CROs are one option for pharmaceutical companies, particularly those which entered Asian markets early. Their local language and cultural understanding can lead to better relationships with regulators and investigators, ultimately leading to better trail execution, ACRO noted.

The long-standing relationships built by CROs can also build trust with communities where clinical trials are taking place, particularly if there has been controversy surrounding medical research in the past.

4. Ethics

While strides have been made in improving the ethics surrounding clinical trials in Asia in recent years, concerns still remain. Companies must consider the ethical implications of undertaking trials in countries where they are not intending to market the drug.

This is a particular consideration in countries where the population is poor and access to free healthcare is extremely limited, such as India, where the ethics surrounding clinical trials have been in the spotlight recently.

Reports suggest only a handful of ethics committees in the country have been granted official accreditation, and these rarely release details of how they function.

5. Enrolling patients

Figures show the number of patients participating in the clinical trials is increasing. Previous research from the French organisation Les Entreprises Du Medicament found a 40 percent increase in the number of patients being used in trials by major pharmaceutical companies between 2006 and 2008.

Emerging markets with their large patient pools are essential for filling this role, however, increasing competition is making this resource harder to access. Countries such as China, Indonesia, Japan, the Philippines, Thailand and Malaysia are proving more of a challenge, World Pharma noted, making less populous countries potentially more attractive.

6. Different regulations and changing environments

Regulatory environments differ across Asian nations, and these separate bodies of regulations are evolving as countries look to facilitate a greater number of clinical trials. Although more are looking to harmonise with the Food and Drug Administration and European Union, gaps remain.

In a recent Cutting Edge report into Clinical Research in Asia, it was noted that despite the growth being seen in CROs in China, "multiple study respondents stress the difficulty of establishing FDA-level oversight when using vendors in the country".

7. Standards of medical care

Treatment for breast cancer, lung cancer and diabetes, including a number of other diseases, in Asia is of a similar standard as that delivered in the west, World Pharma notes, yet this is certainly not the case for all conditions.

As with the availability of resources and facilities, standards are also likely to vary between sites, as well as countries, and pharmaceutical companies are likely to want to undertake their clinical trials in countries where standards are closest aligned with the United States and the EU.

 

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