While browsing the internet the other day, I came across an interesting article on the aging population in China.¹ Advances in healthcare and nutrition, combined with a one child policy, have resulted in a rapid demographic change towards an older average population. This provides an opportunity for pharmaceutical companies to provide more medical supplies to the aging population, but it also puts a strain on the Chinese government to increase its budgetary policy to accommodate predicted heightened healthcare expenses.
It intrigues me to see the high number of clinical trials currently being conducted in China. According to www.clinicaltrial.gov, 5,552 studies have been registered throughout the world, of which 5,045 involved China (i.e. 90%). Being a Chinese national and resident of China with a career in clinical trial supplies, the reasons for this are obvious.
- An aging population, as outlined above
- A high increase in infectious diseases
- A rapid rise in chronic diseases including cardio-vascular disease, diabetes, cancer
- An extremely densely populated pool of patients
- Access to naive patient pools
- Rapid patient enrollment (with quoted savings of 30% on enrollment time due to urbanization)
- A talent pool of highly trained healthcare professionals
- Improved infrastructure
- Lower costs in comparison to western countries
Notwithstanding all of these positive points, there are a few considerations which should be taken into account by companies conducting clinical research in China. These considerations include a challenging regulatory landscape with often protracted timelines for clinical trial approvals; changing healthcare policies; import/export requirements; non-compliance to GCP (Good Clinical Practice) guidelines; not to mention cultural and language barriers. Add to this the recent media coverage of pharma executives weighing leaving China in wake of widening corruption crackdown.²
My next blog article will outline my own "Top 7 Tips for running clinical trials in China” measures to take to help you overcome the challenges we have discussed here.
(2) FiercePharma – pharma execs weigh leaving China in wake of widening corruption crackdown
(3) CFDA – China Food and Drug Administration