The number of clinical trials conducted in the Asia-Pacific Rim is increasing, rising from 6% of the global total in 2005/2007 to 10% in 2011. (Clinical Trial Magnifier 2011,http://ctmagnifier.org/2011/M2011_4_01.aspx) One of the key factors driving growth is faster study start-up times compared with the West. Much of this timeline compression can be attributed to two issues: patient recruitment and regulatory approvals.
With over 60% of the world’s population living in Asia, (PriceWaterhouseCoopers 2009,http://www.pwc.be/en/pharma/The-changing-dynamics-of-pharma-outsourcing-in-Asia.pdf) one of the main reasons that trials enroll quickly is the sheer number of available patients. However, there are several other important factors that should not be overlooked.
- Patients in Asia often have fewer healthcare options than in the West, making clinical trials an attractive source of affordable care.
- The growing influence of Western culture means that an increasing number people in Asia are suffering from heavily researched conditions, such as diabetes, cardiovascular disease, and cancer.
- With fewer clinical trials enrolling, there is less competition for patients in a particular therapeutic area.
- As qualified trial sites tend to be in large, urban hospitals, the number of eligible patients at each site is higher than in the West.
- Doctors are revered in many Asian cultures, making patients in Asia more likely than their Western counterparts to follow a physician’s advice to enroll in a trial.
While regulatory timelines historically have been a significant hurdle when starting clinical trials, the median time for regulatory approval has decreased drastically in many Asian countries over the last decade. This improvement is particularly pronounced in some of the smaller countries in Southeast Asia, where governments have identified medical science as a key area for economic growth. For example, regulatory approval of a clinical trial usually takes less than 2 months in Singapore, Malaysia, the Philippines, and Indonesia. (Wong 2008, http://www.diahome.org/productfiles/8357/diaj_28111.pdf)
In contrast, regulatory timelines tend to be longer in the larger Asian countries, with approvals requiring approximately 9 months in India and 12 months in China. (PriceWaterhouseCoopers 2009,http://www.pwc.be/en/pharma/The-changing-dynamics-of-pharma-outsourcing-in-Asia.pdf) Fortunately, the regulatory delays can be somewhat offset by the huge treatment-naïve populations in these areas. Faster start-up times are a key reason to conduct clinical trials in Asia. Understanding why this difference occurs allows sponsors to further streamline processes in this large “pharmerging” market.